Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT06883708

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

Led by Sunway University · Updated on 2025-03-19

70

Participants Needed

4

Research Sites

94 weeks

Total Duration

On this page

Sponsors

S

Sunway University

Lead Sponsor

S

Sarawak General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years and older, any gender
  • Able to understand written Malay language
  • Self-reported caregiver of a person living with any form of dementia (score 2 2 on the AD8)
  • Providing unpaid care to the person living with dementia for at least 6 months at recruitment
  • Experiencing psychological distress indicated by subjective burden (score 2 4 on 1-item burden scale), or symptoms of depression or anxiety (score 2 8 on depression or anxiety subscales of HADS)
  • Regular internet user, using the internet at least twice a week
Not Eligible

You will not qualify if you...

  • Previously participated in Phase 1 iSupport-Malaysia studies (focus groups, usability testing)
  • Another family member in the same household has participated or is currently participating in the iSupport study
  • Limited comprehension of written Malay language
  • No access to a device with internet connection more than twice a week
  • Unable or unwilling to provide written informed consent

AI-Screening

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Trial Site Locations

Total: 4 locations

1

University Malaya Medical Centre, Selangor

Petaling Jaya, Kuala Lumpur, Malaysia, 50603

Actively Recruiting

2

Sarawak Heart Centre

Kota Samarahan, Sarawak, Malaysia, 94300

Actively Recruiting

3

Sarawak General Hospital

Kuching, Sarawak, Malaysia, 93586

Actively Recruiting

4

Sunway University

Subang Jaya, Selangor, Malaysia, 47500

Actively Recruiting

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Research Team

A

Alvin Lai Oon Ng, DPsych

CONTACT

K

Ken Joey Loh, MPsych

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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