NCT06883708 Feasibility & Preliminary Impacts of an Online Psychoeducational Program (iSupport-Malaysia) for Informal Dementia Caregivers
| NCT ID | NCT06883708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunway University |
| Condition | Caregiver Subjective Burden |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-02-05 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 * Experience some extent of psychological distress, such that they should experience some levels of subjective burden (defined by a score of ≥ 4 on the 1-item burden scale ranging from 1 to 10), OR some symptoms of depression OR anxiety (defined by a score of ≥ 8 on either the 'depression' or 'anxiety' subscales of HADS) * Regular internet user, defined as using the internet at least twice a week. Exclusion Criteria: * 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 * Unable or unwilling to provide written informed consent
Contact & Investigator
Ken Joey Loh, MPsych
PRINCIPAL INVESTIGATOR
Sunway University
Frequently Asked Questions
Who can join the NCT06883708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Caregiver Subjective Burden. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06883708 currently recruiting?
Yes, NCT06883708 is actively recruiting participants. Contact the research team at alvinn@sunway.edu.my for enrollment information.
Where is the NCT06883708 trial being conducted?
This trial is being conducted at Petaling Jaya, Malaysia, Kota Samarahan, Malaysia, Kuching, Malaysia, Subang Jaya, Malaysia.
Who is sponsoring the NCT06883708 clinical trial?
NCT06883708 is sponsored by Sunway University. The principal investigator is Ken Joey Loh, MPsych at Sunway University. The trial plans to enroll 70 participants.