Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial

Abstract Background Caregivers of people with dementia (PwD) face burden, feelings of loneliness, and social isolation. Previous studies have shown promising effects of online e-health interventions. Using social media may facilitate support for dementia caregiver networks. In an iterative step-wise approach, a social support tool entitled “Inlife” was developed. This paper describes the design of a study evaluating the effects of Inlife and its process characteristics. Methods A mixed-method, randomised controlled trial with 122 caregivers of PwD will be conducted. Participants will be assigned to either the Inlife social support intervention or a waiting-list control group. After 16 weeks, the control group will obtain access to the Inlife environment. Data will be collected at baseline (T0) and at 8-week (T1), 16-week (T2) and 42-week follow up (T3). The 16-week follow-up assessment (T2) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. The primary outcomes include feelings of caregiver competence and perceived social support. The secondary outcomes include received support, feelings of loneliness, psychological complaints (e.g., anxiety, stress), and quality of life. A process evaluation, including semi-structured interviews, will be conducted to examine the internal and external validity of the intervention. Discussion Using a mixed-method design, our study will provide valuable insights into the usability, effectiveness, and factors related to implementation of the Inlife intervention. Our study results will indicate whether Inlife could be a valuable social support resource in future routine dementia care. Trial registration Dutch trial register, NTR6131 . Registered on 20 October 2016

Development and feasibility of Inlife:A pilot study of an online social support intervention for informal caregivers of people with dementia

Informal caregivers of individuals with dementia have an increased risk to face social isolation due to progression of the disease. Online social media interventions might offer a new opportunity to increase access to social support and enhance positive interactions and openness in dementia care networks.This explorative pilot study describes (1) the development of an online social support intervention Inlife, and (2) the evaluation of the feasibility of this intervention and the measurements to assess its effectiveness.The Medical Research Council (MRC) framework guided the development of the online social support intervention. This is a stepwise approach that integrates potential users' views with the development and validation of the program content. The program was developed by combining (1) individual caregiver interviews (n = 10), (2) focus group sessions with experts and web designers (n = 6), and (3) individual think-aloud tests (n = 2). Subsequently, a pilot study with informal caregivers was conducted (n = 25) to examine the program's feasibility and preliminary effectiveness. Online self-report measures were completed at baseline and at four follow-up time points.In total, 23 participants completed the newly developed Inlife intervention. Despite the high number of low-active users (17/23, 73%), Inlife had a good feasibility score of 7.1 (range: 1-10). The Calendar and Timeline were used most frequently and contributed to better care coordination and positive interactions.Although the Inlife platform received a sufficient feasibility rating, the uptake was not optimal. Therefore, the Inlife platform was adapted to limit the number of low-active users and improve user friendliness. Recommendations for additional treatment adherence were provided. The development according to the MRC framework and the sufficient feasibility rating of Inlife formed the basis for a future effectiveness study

Executed sprints during the iterative development process.

<p>Executed sprints during the iterative development process.</p

Iterative development and piloting process informed by the elements of the MRC framework.

<p>Iterative development and piloting process informed by the elements of the MRC framework.</p

Overview of positive, negative and neutral evaluations of the features of the Inlife platform.

<p>Overview of positive, negative and neutral evaluations of the features of the Inlife platform.</p

Functionalities and content of the Inlife web application.

<p>Functionalities and content of the Inlife web application.</p

Inlife program questionnaire.

<p>Inlife program questionnaire.</p