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

NCT06883708 | Recruiting

• 3 other identifiers: iSupport-Malaysia 2024/REC0133NMRR-ID-24-01472-ZAIMRECID 202499-14190
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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. 1.How feasible is it to implement iSupport-Malaysia as an accessible resource for ICs of PLWD in Malaysia?
2. 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. 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. 4.What are the perceptions of ICs of PLWD on the usability, satisfaction and perceived usefulness of the modules in iSupport-Malaysia?

Conditions

Caregiver Subjective Burden; Caregiver Wellbeing; Feasibility Pilot Study

Keywords

informal caregivers; dementia; caregiver support; internet-based intervention; psychoeducation

Outcome Measures

Primary Outcomes (4)

• Recruitment Feasibility

  Percentage of ICs who meet the eligibility criteria among all the screened ICs of PLWD.

  Screening

• Randomisation Feasibility

  Percentage of ICs who agree to randomisation among all eligible ICs.

  Baseline

• Retention Rates

  Percentage of participants retained until the end of the study in both arms.

  3 months

• Program Engagement Rate

  Percentage of ICs who comply to the treatment protocol in both arms.

  3 months

Secondary Outcomes (4)

• Zarit Burden Interview (ZBI), Malay version

  Baseline, 1 month, 3 months

• Hospital Anxiety & Depression Scale (HADS), Malay version

  Baseline, 1 month, 3 months

• Perceived Stress Scale (PSS-10), Malay version

  Baseline, 1 month, 3 months

• WHO Quality of Life, Brief Version (WHOQOL-BREF), Malay version

  Baseline, 1 month, 3 months

Other Outcomes (4)

• System Usability Scale (SUS), Malay version

  3 months

• Ascertain Dementia 8-item (AD8), Malay version

  Screening

• Sociodemographic Data

  Screening, baseline

Study Arms (2)

iSupport-Malaysia Web-Based Intervention

EXPERIMENTAL

Access to the online, web-based version of iSupport-Malaysia throughout the 3-month study period. The 23 lessons will be arranged under the 5 modules in the same way as the original iSupport manual. Each lesson will be delivered in bite-sized knowledge, using engaging videos, interactive quizzes with feedback, and reflection exercises. Each lesson will take an average of 10-20 minutes to complete. At the end of each lesson, a completion batch will be given. The lesson plan can be personalised by the caregivers themselves according to individual needs. Caregivers will also have the option to receive a course completion certificate if they successfully completed all 23 lessons in the program. Additionally, in each lesson, participants are encouraged to post comments in response to the prompt questions, and also reply to others' comments.

Behavioral: iSupport-Malaysia Web-Based Intervention

iSupport-Malaysia eBook

ACTIVE COMPARATOR

Receive the Malay-translated, culturally adapted version of the 'iSupport for Dementia' manual in PDF format throughout the 3-month study period. This eBook is approximately 275 pages long, containing comprehensive text-based details for the 5 modules and 23 lessons. The modules and lessons are similar to the iSupport-Malaysia web-based program. Each lesson includes at least one case 1 scenario(s) presented in a quiz format. Some lessons offer additional worksheets for caregivers to reflect on their own caregiving experiences and apply the strategies learned to their caregiving journey. A completion batch is given at the end of each lesson. The lesson plan can be personalised by the caregivers themselves according to individual needs.

Behavioral: iSupport-Malaysia eBook

Interventions

iSupport-Malaysia Web-Based Intervention BEHAVIORAL

iSupport-Malaysia web-based intervention is a website version of the culturally adapted "iSupport for Dementia" into the Malaysia context (in local Malay language). The 23 lessons is arranged under the 5 modules in the same way as the original iSupport manual. Each lesson is delivered in bite-sized knowledge, using engaging videos, interactive quizzes with feedback, and reflection exercises. Each lesson takes an average of 10-20 minutes to complete. At the end of each lesson, a completion batch is given. The lesson plan can be personalised by the caregivers themselves according to individual needs. Caregivers will also have the option to receive a course completion certificate if they completed all 23 lessons in the program. Additionally, in each lesson, participants are encouraged to post comments in response to the prompt questions, and also reply to others' comments.

iSupport-Malaysia Web-Based Intervention

iSupport-Malaysia eBook BEHAVIORAL

iSupport-Malaysia eBook is the Malay-translated, culturally adapted version of the "iSupport for Dementia" manual in PDF format. This eBook is approximately 275 pages long, containing comprehensive text-based details for the 5 modules and 23 lessons. The modules and lessons are similar to the iSupport-Malaysia web-based program. The main lesson content is delivered in text-based format. Each lesson includes at least one case 1 scenario(s) presented in a quiz format. Some lessons offer additional worksheets for caregivers to reflect on their own caregiving experiences and apply the strategies learned to their caregiving journey. A completion batch is given at the end of each lesson. The lesson plan can be personalised by the caregivers themselves according to individual needs.

iSupport-Malaysia eBook

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunway University: lead
• Sarawak General Hospital: collaborator
• Sarawak Heart Centre: collaborator
• University of Malaya: collaborator

Study Sites (4)

University Malaya Medical Centre, Selangor

Petaling Jaya, Kuala Lumpur, 50603, Malaysia

RECRUITING

Sarawak Heart Centre

Kota Samarahan, Sarawak, 94300, Malaysia

RECRUITING

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Sunway University

Subang Jaya, Selangor, 47500, Malaysia

RECRUITING

Related Publications (1)

• Loh KJ, Ng ALO, Chia YC, Lee WL, Mohan D, Renganathan E. Caring for people living with dementia and their informal caregivers: Current perspectives in Malaysia. Malays Fam Physician. 2024 Dec 27;19:69. doi: 10.51866/cm.674. eCollection 2024.

  PMID: 39780913 BACKGROUND

Related Links

• World Health Organisation (2019). iSupport for Dementia: Training and support manual for carers of people with dementia.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ken Joey Loh, MPsych

  Sunway University

  PRINCIPAL INVESTIGATOR

• Alvin Lai Oon Ng, DPsych

  Sunway University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvin Lai Oon Ng, DPsych

CONTACT

+603-7491 8622; alvinn@sunway.edu.my

Ken Joey Loh, MPsych

CONTACT

+6016-601 5132; ken.l25@imail.sunway.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants are aware of the intervention they receive (web program or eBook). Nonetheless, site investigators involved in recruitment are blinded to the randomisation sequence. The data analyst will also be blinded to the intervention assigned to the participants, as all participants' data are labelled using universal subject IDs that do not distinguish between groups of participants. Data collection of baseline and post-intervention assessments will be self-administered online by the participants and remain anonymous. Hence, researchers have no influence over the outcomes of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist & PhD Candidate

Model Details: Experimental parallel between-group design with two arms

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: February 5, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Interested researchers should submit a reasonable request to the corresponding author (alvinn@sunway.edu.my). The requestor will need to sign a data access agreement that agrees to use the data solely for reasons outlined in the request.

Locations

MY (4)