Comparing the Effectiveness of a Web-Based Application With a Digital Live Seminar to Improve Safe Communication for Pregnant Women: 3-Group Partially Randomized Controlled Trial

Background Medical internet interventions such as asynchronous apps and synchronous digital live seminars can be effective behavior change interventions. The research question of this study was whether digital interventions based on the Health Action Process Approach can improve pregnant women’s safe communication and patient safety in obstetric care. Objective This study aims to compare a digital live seminar with a web-based application intervention and a passive control group and to identify which social cognitive variables determine safe communication behavior and patient safety. Methods In total, 657 pregnant women were recruited, and hereof, 367 expectant mothers from 2 German university hospitals participated in the pre-post study (live seminar: n=142; web-based app: n=81; passive control group: n=144). All interventions targeted intention, planning, self-efficacy, and communication of personal preferences. The 2.5-hour midwife-assisted live seminar included exercises on empathy and clear communication. The fully automated web-based application consisted of 9 consecutive training lessons with the same content as that of the live seminar. Results Controlled for sociodemographic characteristics, repeated measures analyses of covariance revealed that pregnant women significantly improved their self-reported communication behavior in all groups. The improvement was more pronounced after the digital live seminar than after the web-based application (P<.001; ηp2=0.043). Perceived patient safety improved more for pregnant women participating in the live seminar than for those participating in the web-based application group (P=.03 ηp2=0.015). A regression analysis revealed that social cognitive variables predicted safe communication behavior. Conclusions Overall, the web-based application intervention appeared to be less effective than the digital live training in terms of communication behavior. Application interventions addressing communication behaviors might require more face-to-face elements. Improving intention, coping planning, and coping self-efficacy appeared to be key drivers in developing safe communication behavior in pregnant women. Future research should include social learning aspects and focus on the practical application of medical internet interventions when aiming to improve pregnant women’s communication and patient safety in obstetrics. Trial Registration ClinicalTrials.gov NCT03855735; https://clinicaltrials.gov/ct2/show/NCT03855735

Approx. Percentage of Users (starters) still using the app as recommended after Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) subitem not at all important 1 2 3 4 5 essential 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o�ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study web-based app

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Your answer must have a minimum of 25 characters.
subitem not at all important Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study digital live seminar 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study The study aimed to compare a digital live seminar to a web-based app intervention and a passive control group, and to identify which social-cognitive variables determine safe communication behaviour and patient safety.

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Improving safe communication behaviour in clinics in order to reduce preventable adverse events.

METHODS
3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study H1: Pregnant women who used the web-based app prior to giving birth will improve in the primary outcome of safe communication behaviour and the secondary outcome of perceived patient safety more than women from a passive control group. Their improvement is comparable to an intervention group that received an online intervention (online live seminar). H2: The HAPA model can explain safe communication behaviour of pregnant women after web-based app interventions: Coping planning, coping self-efficacy, and intention are associated with safe communication behaviour after the digital interventions. H3: Perceived patient safety is associated with safe communication behaviour after webbased app use.
Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study The randomization for the live seminar was prepared and performed by project affiliated team members (study nurses and research assistants) at the two hospitals. For this purpose, closed envelopes were prepared in a ratio of 3:2 for N=222 (77.6%) of the pregnant women. A third group of expectant mothers were recruited for the web-based app intervention (IG2).
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS... 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study >18 years, fluent in German, pregnant at the moment of participation, delivery at one of the two university clinics

3b-i) Bug fixes, Downtimes, Content Changes
Bug �xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug �xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in�uenced study design such as staff changes, system failures/downtimes, etc. [2].
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4a) Eligibility criteria for participants
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study >18 years, fluent in German, pregnant at the moment of participation, delivery at one of the two university clinics

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari�ed.
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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o�ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con�rmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study web-based vs. digital live seminar vs. control group 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

4b) Settings and locations where the data were collected
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-iii?
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Meine Antwort
Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study At two university hospitals 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Does your paper address subitem 4b-ii?
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Meine Antwort
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, a�liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con�ict of interest" section or mentioned elsewhere in the manuscript).

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5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
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5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

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5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Meine Antwort 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing �owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti�c reporting.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-v?
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5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
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5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci�c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study free access via a website or microsoft teams for live seminar Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study web app included 10 learning units specifically created for the project (self-managed learning). Live seminars: digitally delivered via microsoft teams in form of group discussions and presentations.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
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5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important 1 2 3 4 5 essential Your answer must have a minimum of 25 characters.
Does your paper address subitem 5-x?
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5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study No reminders were given.
subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study The aim of the study was to compare and identify the effectiveness of different digital intervention modes for pregnant women regarding the primary outcome of safe communication behaviour and the secondary outcome of perceived patient safety in obstetric care. It was hypothesized that participation in a digital web-based app would prove equally effective as a live seminar and more effective than a passive control group. However, this could empirically not be supported: compared to the intervention group, the pregnant women who used the web-based training app improved their safe communication behaviour significantly less, and not more than a passive control group that did not receive any intervention. The effectiveness of the two interventions were evaluated with a repeated measured ANCOVA. essential 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de�ned/measured/monitored (logins, log�le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?

Copy and paste relevant sections from manuscript text
Meine Antwort 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

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6b) Any changes to trial outcomes after the trial commenced, with reasons
Your answer must have a minimum of 25 characters.

7a) How sample size was determined
NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study No changes were made.

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.

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7b) When applicable, explanation of any interim analyses and stopping guidelines
Your answer must have a minimum of 25 characters.

8a) Method used to generate the random allocation sequence
NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study n.A Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

9)
Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study The randomization for the live seminar was prepared and performed by project affiliated team members (study nurses and research assistants) at the two hospitals. For this purpose, closed envelopes were prepared in a ratio of 3:2 for N=222 (77.6%) of the pregnant women.
Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study For this purpose, closed envelopes were prepared in a ratio of 3:2 for N=222 (77.6%) of the pregnant women.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS... 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Project affiliated team members 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study For this purpose, closed envelopes were prepared in a ratio of 3:2 for N=222 (77.6%) of the pregnant women.
subitem not at all important 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

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Meine Antwort
Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study n.A CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Missing values occurred in less than 5% of all cases. Thus, missing data was handled via listwise deletion. Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study sociodemographic characteristics were controlled for in all analyses

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
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X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
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RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study N=367 (NIG= 142, NCG= 144, NApp= 81) expectant women participated in the two survey waves, while providing matchable codes and were thus included for data analysis.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other �gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the �gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

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Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Between June 2020 and August 2021, participants were randomized to either an intervention group (IG1) that received a digital live seminar training, or a passive control group (CG). To ensure that the live seminar worked in a group setting, N = 12 (8.4%) of N = 144 women who provided postpartum survey data for the intervention group were not randomized but were assigned when the live intervention started between August 2021 and June 2022, a third group of expectant mothers were recruited for the web-based app intervention (IG2) subitem not at all important 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi�cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

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Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide de�nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci�c pre-de�ned time points of interest (in absolute and relative numbers per group). Always clearly de�ne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study There was a significant time X group interaction effect, meaning that the change of communication behaviour across time differed between the live seminar group and the webbased app group: F(1,336) = 15.046, P<.001, ηp2= .043. Between the control group and the web-based app group no significant time X group interaction effect emerged F(1,336) = 2,732 P=.099, ηp2= .008. There was a significant time X group interaction effect, meaning that change in perceived patient safety across time did significantly differ between the live seminar group and the web-based app F(1,304)=4.709, P<.031, ηp2= .015.There was no significant time X group interaction effect between the control group and the web-based app group F(1,304)= 0.108, P= .742, ηp2= <.001.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study There was a significant time X group interaction effect, meaning that the change of communication behaviour across time differed between the live seminar group and the webbased app group: F(1,336) = 15.046, P<.001, ηp2= .043. Between the control group and the web-based app group no significant time X group interaction effect emerged F(1,336) = 2,732 P=.099, ηp2= .008. There was a significant time X group interaction effect, meaning that change in perceived patient safety across time did significantly differ between the live seminar group and the web-based app F(1,304)=4.709, P<.031, ηp2= .015.There was no significant time X group interaction effect between the control group and the web-based app group F(1,304)= 0.108, P= .742, ηp2= <.001.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS... In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de�nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de�ned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study All analyses controlled for age, marrital status, education level and nationality

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Meine Antwort
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study The aim of the study was to compare and identify the effectiveness of different digital intervention modes for pregnant women regarding the primary outcome of safe communication behaviour and the secondary outcome of perceived patient safety in obstetric care. It was hypothesized that participation in a digital web-based app would prove equally effective as a live seminar and more effective than a passive control group. However, this could empirically not be supported: compared to the intervention group, the pregnant women who used the web-based training app improved their safe communication behaviour significantly less, and not more than a passive control group that did not receive any intervention.

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Meine Antwort

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

21) Generalisability (external validity, applicability) of the trial findings
NPT: External validity of the trial �ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study From a methodological perspective, the group of web-based app users was smaller than the other two groups. Absolute sample size as well as potential distortions (for example, due to dropout issues and social desirability) might explain the difference between hypothesized and empirically observed group differences [63,64]. The use of the web-based app by expectant mothers took place without further observation or consultation with the research staff, which is why interference effects (for example frequent interruption of an exercise, multitasking, or environment) could not be controlled for. The assessments were selfreported measures and thus potentially biased by subjective beliefs and social desirability. Additionally, we used only subjective reports and single-item scales due to reasons of feasibility, but they might have had a low reliability. Therefore, future research might benefit from developing and further validating multi-item scales to assess safe communication behaviour or use observations assessments for a more objective assessment. This could offer additional insights regarding potential subjectivity within the self-reported measures. In this study, mostly well-educated women participated which probably had an effect on the results and thus limits generalizability. The web-based app should also be tested and verified with other socio-demographic groups with lower levels of education and migration backgrounds [40,65]. Consequently, future studies should aim for a more diverse participant pool [40,66]. Collaborations with cultural associations or municipal services could aid in this strategy and the sustainability of the intervention [55].

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study yes no Sonstiges: STOP -Save this form as PDF before you click submit To generate a record that you �lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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