Resilience-Building Intervention for Older Informal Caregivers

NCT07712744 | Not Yet Recruiting

• 2 other identifiers: NUS-IRB-2023-889A-8001599-00-00
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Resilience, Psychological; Older Adults (60 - 85 Years Old); Community Dwelling; Informal Caregiver

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

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

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

• Participant Retention Rate

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

  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.

• 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.

  Throughout the 8-week intervention period.

• 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

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

• AI Chatbot Usability

  Usability of the AI chatbot will be assessed using the Simplified System Usability Scale (SUS). The SUS consists of 10 items rated on a 5-point Likert scale. Responses are converted to produce a total score ranging from 0 to 100, with higher scores indicating better perceived usability.

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

Secondary Outcomes (6)

• Psychological Resilience

  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.

• Intrinsic Capacity

  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.

• Health Self-Efficacy

  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.

• Social Isolation

  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.

• Caregiver burden

  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 (2)

• Exploratory digital engagement outcomes

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

• Intracluster Correlation Coefficient for Future Trial Planning

  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.

Study Arms (3)

Multicomponent Resilience-building Program

EXPERIMENTAL

8-week multicomponent resilience-building intervention comprising alternating weekly in-person and online sessions. Key components include: 1) psychoeducation; 2) peer support group sharing; and 3) access to an AI chatbot for caregiving support.

Behavioral: Multicomponent Resilience-building Program

AI Chatbot and Telephone Follow-up Group

ACTIVE COMPARATOR

Access to the AI chatbot trained using local official health education and caregiving support resources, with weekly telephone follow-up calls to guide chatbot use and address technical difficulties.

Behavioral: AI Chatbot and Telephone Follow-up Group

Usual Practice

NO INTERVENTION

Participants in the control arm will not receive the intervention or access to the AI chatbot during the study period until the last follow-up assessment. They will continue their usual caregiving routine and existing care practices as usual.

Interventions

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.

Multicomponent Resilience-building Program

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.

AI Chatbot and Telephone Follow-up Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Have an Abbreviated Mental Test (AMT) score of 8 or above;
• Self-identify as an informal caregiver providing unpaid care to a family member, friend, or other individual;
• Provide care to a care recipient with impairment in at least one activity of daily living, as assessed using the Older Americans Resources and Services Activities of Daily Living (OARS-ADL) scale;
• Have at least weekly contact with the care recipient.

You may not qualify if:

• 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;
• Provide care primarily to grandchildren or children under 18 years of age, rather than to an adult with functional impairment.

Sponsors & Collaborators

• National University of Singapore: lead
• Lions Befrienders Service Association (Singapore): collaborator
• FlocCare Pte. Ltd: collaborator
• National University Health System, Singapore: collaborator

Central Study Contacts

Ruochen Feng

CONTACT

+6566012756; rfeng@nus.edu.sg

Vivien Xi Wu

CONTACT

vivien.wu@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Group allocation will be coded using neutral labels (e.g., Group A, Group B, and Group C) throughout data management and analysis. Due to the nature of the intervention, participants and intervention facilitators cannot be masked to group allocation. As all outcomes are assessed using self-reported questionnaires, outcome assessor masking is not applicable. Data analysts will remain masked to group allocation until the primary feasibility and outcome analyses have been completed and documented. Unmasking will occur only after the analysis plan has been finalized and all primary analyses have been conducted.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study uses a 3-arm parallel cluster randomized design. Participating Active Ageing Centres will be randomly assigned to one of three groups: the THRIVE intervention group, the active control group, or the usual care control group.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07