Resilience-Building Intervention for Older Informal Caregivers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorNational University of Singapore

About this trial

The goal of this pilot study is to test whether a newly developed resilience-building program is feasible and acceptable for older adults who provide unpaid care to people with functional impairment in the community. The program was developed based on earlier research with older caregivers, existing scientific evidence, and feedback from key stakeholders.

The main questions this study aims to answer are:

* Can older caregivers be successfully recruited and retained in the study? * Is the program feasible and acceptable to deliver in community settings? * Does the program show potential to improve resilience among older caregivers?

Researchers will compare:

* an intervention group receiving an 8-week multicomponent resilience-building intervention delivered through alternating in-person and online sessions at participating Active Ageing Centres and through Telegram group video calls. The program includes psychoeducation, peer support group, and access to an artificial intelligence (AI) chatbot developed to support caregivers. * an active control group receiving access to the AI chatbot and weekly telephone follow-up only. * a control group continuing their usual caregiving routine.

Participants will:

* Be assigned to 1 of the 3 study groups based on the Active Ageing Centre they attend. * Complete self-reported questionnaires before the intervention (T0, baseline), immediately after the intervention (T1, post-intervention), and 3 months later (T2, follow-up). * Some participants may also be invited to participate in focus group discussions after the 8-week intervention period as part of a process evaluation to explore their experiences, perceived usefulness of the intervention components, barriers and facilitators to participation, and recommendations for refinement.

Findings from this pilot study will help refine the intervention and study procedures of a larger future trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be aged 60 to 85 years;

Reside in the community;

Be attending a participating Lions Befrienders Active Ageing Centre;

Be able to communicate in English or Mandarin;

Disqualifiers

Have severe visual or hearing impairment that would prevent participation in study activities;

Have a known diagnosis of dementia or other severe cognitive impairment;

Have a known diagnosis of a severe psychiatric disorder that may impair study participation (e.g., psychotic disorders);

Have an AMT score below 8;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multicomponent Resilience-building Program

    Behavioral

    Participants in the intervention group will receive the THRIVE program, an 8-week multicomponent resilience-building intervention developed based on prior participant need assessment, empirical evidence on resilience theory and caregiver resilience interventions, and stakeholder input. The intervention aims to strengthen psychological resilience among older informal caregivers. The format will be alternating in-person and online sessions conducted weekly over 8 weeks. In-person sessions will be held at participating Active Ageing Centres, while online sessions will be conducted through Telegram group video calls. Each 1.5-hour session will include: 1) psychoeducation; 2) peer support group sharing; and 3) an AI chatbot trained using local official resources. Sessions will be delivered by the same trained facilitator using a standardized intervention protocol. An independent observer will complete a fidelity checklist during each session to assess adherence to the protocol.

  • AI Chatbot and Telephone Follow-up Group

    Behavioral

    Participants will receive access to the same AI chatbot trained using information from local official health education and caregiving support resources. Participants will also receive weekly telephone follow-up calls from the research team over the 8-week study period. The telephone follow-ups aim to: 1) encourage use of the AI chatbot; 2) address any technical difficulties encountered during chatbot use; and 3) gather participants' feedback and experiences using a standardized telephone follow-up guide. All telephone calls will be audio-recorded and reviewed by the research team for fidelity monitoring to ensure consistency of delivery across participants.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Multicomponent Resilience-building ProgramExperimental treatment 1 intervention
Group B: AI Chatbot and Telephone Follow-up GroupActive comparator 1 intervention
Group C: Usual PracticeNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment Rate

Proportion of eligible participants who provide informed consent and complete baseline assessment.

Time frame
From date of randomization until the date of first session of the intervention, assessed up to 2 months.
2

Participant Retention Rate

Proportion of enrolled participants who complete the post-intervention (T1) and 3-month follow-up (T2) assessments.

Time frame
Assessed from the first session of the intervention to Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
3

Intervention Adherence

Participant adherence to intervention activities, including attendance at in-person and online sessions, completion of telephone follow-up calls, and engagement metrics with the AI chatbot.

Time frame
Throughout the 8-week intervention period.
4

Intervention Acceptability

Participant acceptability of the intervention will be assessed using a post-intervention satisfaction survey and qualitative feedback collected through focus group discussions to explore participants' experiences, perceived usefulness of the intervention, barriers and facilitators to participation, and recommendations

Time frame
Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.

Secondary outcomes

1

Psychological Resilience

Assessed using the Connor-Davidson Resilience Scale (CD-RISC-25) to explore preliminary trends in intervention effects on resilience. The CD-RISC-25 consists of 25 items, with total scores ranging from 0 to 100. Higher scores indicate greater psychological resilience.

Time frame
Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
2

Intrinsic Capacity

Intrinsic capacity will be assessed using the World Health Organization (WHO) Integrated Care for Older People (ICOPE) screening tool to explore preliminary trends in intervention effects on intrinsic capacity. The tool assesses six domains of intrinsic capacity. Each domain is scored as 1 if no impairment is identified and 0 if impairment is present, yielding a total score ranging from 0 to 6, with higher scores indicating better intrinsic capacity.

Time frame
Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
3

Health Self-Efficacy

Health self-efficacy will be assessed using the Self-Rated Abilities for Health Practices Scale (SRAHP). The SRAHP consists of 28 items assessing self-perceived ability to perform health-promoting behaviours across four domains: exercise, nutrition, responsible health practices, and psychological well-being. Total scores range from 0 to 112, with higher scores indicating greater health self-efficacy for health-promoting practices.

Time frame
Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
4

Social Isolation

Social isolation will be assessed using the Social Isolation Scale (SIS). The SIS consists of 6 items assessing the size and quality of participants' social relationships and social connectedness. Total scores range from 6 to 30, with higher scores indicating lower levels of social isolation (greater social connectedness) and lower scores indicating greater social isolation.

Time frame
Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.

Other outcomes

1

Exploratory digital engagement outcomes

Assessed using AI chatbot usage analytics, including interaction time, frequency, query categories and click-through rates for recommended resources.

Time frame
Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
2

Intracluster Correlation Coefficient for Future Trial Planning

Estimated for key feasibility and exploratory outcome measures to inform sample size calculation and design considerations for a future definitive cluster randomized controlled trial.

Time frame
Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Singapore

Lead sponsor

Lions Befrienders Service Association (Singapore)

Collaborator

FlocCare Pte. Ltd

Collaborator

National University Health System, Singapore

Collaborator

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