About this trial
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.
Eligibility criteria
Qualifiers
Aged 18 years and older, any gender
Able to understand written Malay language
A self-reported caregiver of person living with any form of dementia (defined by a score of ≥ 2 on the AD8)
Provide unpaid care to the PLWD for at least 6 months at the time of recruitment
Disqualifiers
Already participated in Phase 1 iSupport-Malaysia studies (focus groups, usability testing)
Where another family member in the same household has participated/ currently participating in the iSupport study
Have limited comprehension of written Malay language
Do not have access to a device with an internet connection (e.g. mobile phone, tablet, laptop, desktop) more than twice a week
Trial design
Treatments tested in this trial
- iSupport-Malaysia Web-Based Intervention
- iSupport-Malaysia eBook
Treatment groups
Sponsors and collaborators
Sunway University
Lead sponsor
Sarawak General Hospital
Collaborator
Sarawak Heart Centre
Collaborator
University of Malaya
Collaborator