Feasibility & Preliminary Impacts of an Online Psychoeducational Program (iSupport-Malaysia) for Informal Dementia Caregivers

The general objective of this pilot feasibility study is to implement the pilot randomised controlled trial (RCT) and evaluate the feasibility of its methods and procedures for iSupport-Malaysia intervention. Another objective is to assess the acceptability and preliminary impacts of the iSupport-Malaysia web-based intervention on the psychological well-being of informal caregivers (ICs) of persons living with dementia (PLWDs) in Malaysia, compared to iSupport-Malaysia eBook. The main questions this pilot study aims to answer are: 1. How feasible is it to implement iSupport-Malaysia as an accessible resource for ICs of PLWD in Malaysia? 2. Does the use of iSupport-Malaysia lead to a reduction in caregiver burden among the ICs of PLWD in both web and eBook conditions? 3. Does the use of iSupport-Malaysia lead to improvements in psychological well-being (e.g. reduced depression, anxiety, stress; and increased quality of life) among the ICs of PLWD in both web and eBook conditions? 4. What are the perceptions of ICs of PLWD on the usability, satisfaction and perceived usefulness of the modules in iSupport-Malaysia? To answer these research questions: Seventy ICs of PLWD who met the study criteria will be recruited from the geriatric facilities of three hospitals, as well as via social media and referrals from elderly care centres. Eligible participants will sign an informed consent form, and be randomly assigned to the intervention (iSupport-Malaysia web program) or active comparison group (iSupport-Malaysia eBook) using stratified block randomisation. In both arms, participants are required to complete at least 10 out of 23 lessons within 3 months. Outcome measures will be administered online at baseline, 1-month and 3-month follow-up. Feasibility outcomes will also be measured. Upon completion of the program, ICs in the experimental group will be invited for in-depth interviews via an online teleconferencing platform. Expected outputs: A free, adaptive web-based iSupport-Malaysia in the local Malay language. iSupport-Malaysia can facilitate self-directed training in public and private dementia services, integrate into caregiver training programs, and promote self-directed public education on dementia care.

NCT Number	NCT06883708
Lead Sponsor	Sunway University Collaborators: Sarawak General Hospital, Sarawak Heart Centre, University of Malaya
Conditions	Caregiver Subjective Burden, Caregiver Wellbeing, Feasibility Pilot Study
Enrollment	70 participants
Start Date	2025-02-05
Primary Completion	2025-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-03-19