WeChat as a Platform for Baduanjin Intervention in Patients With Stable Chronic Obstructive Pulmonary Disease in China: Retrospective Randomized Controlled Trial

Background Pulmonary rehabilitation is a crucial part of the nonpharmacological treatment of stable chronic obstructive pulmonary disease (COPD), but management remains problematic. WeChat could serve as a useful tool in patient management. Baduanjin is a popular exercise in China that is usually applied in pulmonary rehabilitation, which has been confirmed to be effective in improving lung function and life quality. Objective This study aimed to explore the efficiency of WeChat in the management of Baduanjin exercise in COPD patients. Methods A total of 200 patients from the respiratory department of Putuo Hospital participated in the Baduanjin rehabilitation project from September 2018 to October 2019, and were randomly assigned to the WeChat and control groups and followed up using the WeChat platform or telephone for 12 weeks. The frequency of Baduanjin exercise, lung function (percentage of forced expiratory volume in 1 second predicted, FEV1% predicted), and COPD assessment test (CAT) scores were collected and compared between the two groups. The number of message exchanges and a satisfaction survey on the WeChat platform were used to assess the feasibility of WeChat management outside the hospital. Results The Baduanjin exercise frequency significantly differed between the control group and WeChat group (F=33.82, P<.001) and across various time points (F=214.87, P<.001). After the follow-up on WeChat, there were fewer patients not performing Baduanjin exercise. The FEV1% predicted value significantly differed before and after Baduanjin exercise in the control group (Z=−3.686, P<.001) and the WeChat group (Z=−6.985, P<.001). A significant difference in the FEV1% predicted value was observed after Baduanjin exercise between the two groups (Z=−3.679, P<.001). The CAT score significantly differed before and after Baduanjin exercise in the control group (Z=−4.937, P<.001) and the WeChat group (Z=−5.246, P<.001). A significant difference in the CAT score was observed after Baduanjin exercise between the two groups (Z=−5.246, P<.001). The number of completed Baduanjin exercises, lung function, and CAT scores in active patients were higher than those in nonactive patients. All satisfaction survey items were scored with more than 4 points. Among the items, the highest score (mean 4.54, SD 0.77) was for continued WeChat management, followed by the effective management of Baduanjin exercise (mean 4.46, SD 0.87). The patients in the WeChat group showed much higher enthusiasm for and compliance with Baduanjin exercise, resulting in better life quality and lung function. The patients were very satisfied with the WeChat management because of the obvious curative effect and home feeling. Conclusions The WeChat platform provided a feasible, effective, and sustainable management plan for Baduanjin rehabilitation. Trial Registration Chinese Clinical Trial Registry ChiCTR1900028248; http://www.chictr.org.cn/showprojen.aspx?proj=46995


2a-i) Problem and the type of system/solution
For further information see manuscript, heading "HEADING".

2a-ii) Scientific background, rationale: What is known about the (type of) system
For further information see manuscript, heading "HEADING".

Does your paper address CONSORT subitem 2b?
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3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio
This study was a "parallel controlled study" conducted from September 2018 to October 2019 in Shanghai, China. Two hundred stable COPD patients were included, and the participants were randomly divided into the following two groups "(1:1 ratio)": the WeChat intervention group and routine nursing control group (Figure 1). 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons No. 3b-i) Bug fixes, Downtimes, Content Changes 4a) CONSORT: Eligibility criteria for participants "The inclusion criteria were as follows: (1) 50 to 80 years of age regardless of gender; (2) confirmed clinical diagnosis of stable COPD according to the standard of GOLD 2018 [20]; (3) informed consent (patients and families); (4) ability to use WeChat proficiently (patients and primary caregivers); and (5) ability to perform Baduanjin independently.
The exclusion criteria were as follows: (1) severe heart, liver, and kidney diseases, tumors, or other conditions that may affect the observation; (2) life expectancy less than 1 year; and (3) history of conducting physical exercise for a long time (≥3 times/week, ≥20 minutes/time, persisting for more than 12 months) [21]." 4a-i) Computer / Internet literacy 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: "All patients with stable COPD were discharged from the respiratory medicine ward of a large general hospital.All candidates first completed a brief screening questionnaire. Patients who met the inclusion criteria were invited to participate in the study and received more detailed information regarding the study. After providing written informed consent, all qualified patients were divided into the WeChat group and control group. " 4a-iii) Information giving during recruitment 4b) CONSORT: Settings and locations where the data were collected "The Baduanjin exercise frequency was collected each week in WeChat and once a week by telephone. At the end of the study, the lung function evaluation, quality of life evaluation (CAT), personal activity evaluation, and satisfaction survey were completed by all participants." 4b-i) Report if outcomes were (self-)assessed through online questionnaires At the end of the study, the lung function evaluation, quality of life evaluation (CAT), personal activity evaluation, and" satisfaction survey "were completed by all participants. 4b-ii) Report how institutional affiliations are displayed 5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners

5-vii) Access
"WeChat is the mainstream instant communication platform in China [13]. The "2018 WeChat Annual Data Report" reported that 1.01 billion users logged on to WeChat daily in 2018. The function of the platform is quite strong but is very easy to operate."

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
For further information see manuscript, heading "HEADING".

5-xi) Report any prompts/reminders used
WeChat is an open platform for the masses, and we have no control over its various other reminders. 5-xii) Describe any co-interventions (incl. training/support) "The patients very actively participated in the communication. Responses to all questions were obtained from the medical staff in a timely manner." 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed For further information see manuscript, heading "HEADING". 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons "The Baduanjin exercise frequency was collected each week in WeChat and once a week by telephone. At the end of the study, the lung function evaluation, quality of life evaluation (CAT), personal activity evaluation, and satisfaction survey were completed by all participants." 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size 7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines For further information see manuscript, heading "HEADING". 8a) CONSORT: Method used to generate the random allocation sequence For further information see manuscript, heading "HEADING". 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) "Using the method of block randomization, 200 research patients were randomly assigned to the WeChat and control groups. The block size was defined as four, and there were six sequential arrangements and combinations. Excel (Microsoft Corp) randomly generated 50 (1-50) numbers that did not repeat. Then, the numbers were divided by six to obtain the remainder, and six combinations were matched according to the remainder. A random block group table was then completed. After the research patients were included, the random block table was assigned to a group. By the nature of the trial design, neither the research staff nor the participants were blinded to the intervention." 9) CONSORT: 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 "Using the method of block randomization, 200 research patients were randomly assigned to the WeChat and control groups. The block size was defined as four, and there were six sequential arrangements and combinations. Excel (Microsoft Corp) randomly generated 50 (1-50) numbers that did not repeat. Then, the numbers were divided by six to obtain the remainder, and six combinations were matched according to the remainder. A random block group table was then completed. After the research patients were included, the random block table was assigned to a group. By the nature of the trial design, neither the research staff nor the participants were blinded to the intervention." 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions "Using the method of block randomization, 200 research patients were randomly assigned to the WeChat and control groups. The block size was defined as four, and there were six sequential arrangements and combinations. Excel (Microsoft Corp) randomly generated 50 (1-50) numbers that did not repeat. Then, the numbers were divided by six to obtain the remainder, and six combinations were matched according to the remainder. A random block group table was then completed. After the research patients were included, the random block table was assigned to a group. By the nature of the trial design, neither the research staff nor the participants were blinded to the intervention." 11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't "Using the method of block randomization, 200 research patients were randomly assigned to the WeChat and control groups. The block size was defined as four, and there were six sequential arrangements and combinations. Excel (Microsoft Corp) randomly generated 50 (1-50) numbers that did not repeat. Then, the numbers were divided by six to obtain the remainder, and six combinations were matched according to the remainder. A random block group table was then completed. After the research patients were included, the random block table was assigned to a group. By the nature of the trial design, neither the research staff nor the participants were blinded to the intervention." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" The Baduanjin exercise frequency was collected" each week in WeChat and once a week " by telephone. "At the end of the study (3 months)", the lung function evaluation, quality of life evaluation (CAT), personal activity evaluation, and satisfaction survey were completed by all participants. 14a-i) Indicate if critical "secular events" fell into the study period 14b) CONSORT: Why the trial ended or was stopped (early) No.

15) CONSORT: A table showing baseline demographic and clinical characteristics for each group
For further information see manuscript, heading "HEADING" 15-i) Report demographics associated with digital divide issues For further information see manuscript, heading "HEADING". 16a) CONSORT: For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions For further information see manuscript, heading "HEADING". 16-ii) Primary analysis should be intent-to-treat 17a) CONSORT: For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) For further information see manuscript. 17a-i) Presentation of process outcomes such as metrics of use and intensity of use 17b) CONSORT: For binary outcomes, presentation of both absolute and relative effect sizes is recommended For further information see manuscript. 18) CONSORT: Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory For further information see manuscript.

19) CONSORT: All important harms or unintended effects in each group
No.