An Online Minimally Guided Intervention to Support Family and Other Unpaid Carers of People With Dementia: Protocol for a Randomized Controlled Trial

Background About three-quarters of people with dementia live in their own homes, with help from family members and/or other unpaid carers, such as friends or neighbors. Often, unpaid carers themselves experience negative consequences, such as stress, burden, and symptoms of depression or anxiety. Research has shown that these consequences can be alleviated by psychosocial and psychological interventions. Moreover, there are indications that those interventions can be effective when offered online. Objective This paper describes the protocol of a randomized controlled trial (RCT) that will take place in the Netherlands to evaluate the effectiveness of iSupport, a minimally guided, internet-based intervention to improve carers’ mental health and coping resources. Methods A superiority two-arm RCT comparing the effects of the online support program with a waiting list control condition will be carried out in the Netherlands. The iSupport intervention was developed by the World Health Organization and is based on cognitive behavioral therapy principles. It has five main themes divided into 23 lessons. Carers can pick and choose which lessons they want to complete. We aim to recruit 200 unpaid carers. The experimental group (n=100) will be provided with access to the intervention for 3 months following randomization; those in the waiting list control group (n=100) will be granted access to the intervention after 3 months. Assessments will be conducted at baseline (T0), 3 months after baseline (post intervention, T1), and 6 months after baseline (follow-up, T2). The primary outcome is perceived stress, measured by the Perceived Stress Scale. Secondary outcomes are symptoms of depression and anxiety, caregiver burden, sense of competence, self-efficacy, mastery, and carers’ attitudes toward dementia and their person-centered approach (ie, to what extent carers tailor the provided care to the interest, needs, and history of the person with dementia). Results Recruitment for the trial started in January 2019. As of July 2019, we have enrolled 120 participants. Data collection is expected to be completed by March 2020. Once all the data have been collected, we will conduct the data analyses between April and May 2020. We aim to publish our results in a manuscript by June 2020. Conclusions Online interventions have shown promising results in improving the mental health of carers of people with dementia. Additionally, online interventions may overcome accessibility barriers. If successful, this intervention will have important potential for implementation as a public health intervention, since costs and support by trained staff are minimal. Trial Registration Netherlands Trial Register (NTL) NL6417; https://www.trialregister.nl/trial/6417 International Registered Report Identifier (IRRID) DERR1-10.2196/14106

Dementia raises complex challenges for people with dementia, their families, and society. The European Parliament has called for investment in high quality, innovative technology research to improve dementia care but so far there has been little benefit because research has generally been limited, small scale and methodologically flawed. In particular: the poor understanding between research and business of how people with dementia use technology means new applications are designed without an in-depth appreciation of people's needs, preferences and limitations; there is little knowledge about practical, psychological and social barriers and facilitators to implementation making it hard to get results into practice; there is a serious shortage of research trained professionals who combine expertise on dementia care research and technology. In conjunction with INTERDEM the world's largest network of psychosocial research for people with dementia this ITN will: develop a European multidisciplinary, intersectoral educational research framework for Europe, to comprehensively train 15 early stage researchers (ESRs) to PhD level; provide the research evidence to show how technology may improve care and quality of life for people with dementia; and provide the European workforce with a much needed new generation of excellent research trained professionals. The objectives of INDUCT are to: determine practical, cognitive & social factors to improve usability of technology; evaluate the effectiveness of specific contemporary technology; trace facilitators & barriers for implementation of technology in dementia care. Using advanced methods in applied health research (e.g. randomised controlled trials, qualitative studies) INDUCT will provide the evidence needed to demonstrate how to make dementia care technology more usable, more effective, and better implemented in practice, culminating in an international consensus guideline for improving policy and practice.

Evaluation Summary Report Evaluation Result
Total score: 99.20% (Threshold: 70/100.00) Form information SCORING Scores must be in the range 0-5.

0-
The proposal fails to address the criterion or cannot be assessed due to missing or incomplete information.

1-Poor.
The criterion is inadequately addressed, or there are serious inherent weaknesses.

2-Fair.
The proposal broadly addresses the criterion, but there are significant weaknesses.

3-Good.
The proposal addresses the criterion well, but a number of shortcomings are present.

4-Very good.
The proposal addresses the criterion very well, but a small number of shortcomings are present.

5-Excellent.
The proposal successfully addresses all relevant aspects of the criterion.Any shortcomings are minor.

Criterion 1 -Excellence
Score: 5.00 (Threshold: 0.00/5.00 , Weight: 50.00%) Quality, innovative aspects and credibility of the research programme (including inter/multidisciplinary and intersectoral aspects) Quality and innovative aspects of the training programme (including transferable skills, inter/multidisciplinary and intersectoral aspects) Quality of the supervision (including mandatory joint supervision for EID and EJD projects) Quality of the proposed interaction between the participating organisations

Overall comments
Overall coherence and effectiveness of the work plan, appropriateness of the allocation of tasks and resources have been very convincingly demonstrated. Management structures and procedures as well as infrastructures of participating organisations are highly adequate.

Status: Operational Capacity: Yes
Not provided

EU funding to International / Third Country Organisations
In the case of a participating international organisation, or in the case of a participating legal entity established in a third country not listed in the Annex I of the Work Programme, please confirm whether the participation is deemed essential for carrying out the action (mention the short name(s) of the participant(s) concerned).
Should this proposal be retained for funding, the participant World Health Organisation may exceptionally be granted the requested EU funding.