Resilience-Building Intervention for Older Informal Caregivers
14 luglio 2026 aggiornato da: Vivien Xi WU, PhD, National University of Singapore
Community-Based Resilience-Building Intervention for Older Informal Caregivers: Protocol for a Cluster Randomized Feasibility 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
90
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ruochen Feng
- Numero di telefono: +6566012756
- Email: rfeng@nus.edu.sg
Backup dei contatti dello studio
- Nome: Vivien Xi Wu
- Email: vivien.wu@nus.edu.sg
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Multicomponent Resilience-building Program
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.
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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.
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Comparatore attivo: AI Chatbot and Telephone Follow-up Group
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.
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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.
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Nessun intervento: Usual Practice
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Recruitment Rate
Lasso di tempo: From date of randomization until the date of first session of the intervention, assessed up to 2 months.
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Proportion of eligible participants who provide informed consent and complete baseline assessment.
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From date of randomization until the date of first session of the intervention, assessed up to 2 months.
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Participant Retention Rate
Lasso di tempo: 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.
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Proportion of enrolled participants who complete the post-intervention (T1) and 3-month follow-up (T2) assessments.
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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.
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Intervention Adherence
Lasso di tempo: Throughout the 8-week intervention period.
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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.
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Throughout the 8-week intervention period.
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Intervention Acceptability
Lasso di tempo: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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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
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Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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AI Chatbot Usability
Lasso di tempo: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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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.
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Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Psychological Resilience
Lasso di tempo: 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.
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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.
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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.
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Intrinsic Capacity
Lasso di tempo: 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.
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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.
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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.
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Health Self-Efficacy
Lasso di tempo: 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.
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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.
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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.
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Social Isolation
Lasso di tempo: 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.
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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.
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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.
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Caregiver burden
Lasso di tempo: 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.
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Caregiver burden will be assessed using the 4-item Zarit Burden Interview (ZBI-4).
The ZBI-4 consists of 4 items assessing the perceived impact of caregiving on the caregiver's time, stress, strain, and uncertainty.
Total scores range from 0 to 16, with higher scores indicating greater caregiver burden.
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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.
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Resource Awareness and Navigation
Lasso di tempo: 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.
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This outcome will be assessed using a study-specific 2-item questionnaire developed for this pilot study.
The questionnaire evaluates participants' awareness of caregiving support services and confidence in accessing caregiving support when needed.
Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree).
Total scores range from 2 to 10, with higher scores indicating greater awareness and confidence in accessing caregiving support resources.
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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.
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Exploratory digital engagement outcomes
Lasso di tempo: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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Assessed using AI chatbot usage analytics, including interaction time, frequency, query categories and click-through rates for recommended resources.
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Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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Intracluster Correlation Coefficient for Future Trial Planning
Lasso di tempo: 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.
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Estimated for key feasibility and exploratory outcome measures to inform sample size calculation and design considerations for a future definitive cluster randomized controlled trial.
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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.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 agosto 2026
Completamento primario (Stimato)
31 marzo 2027
Completamento dello studio (Stimato)
31 marzo 2027
Date di iscrizione allo studio
Primo inviato
30 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 luglio 2026
Primo Inserito (Effettivo)
17 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- NUS-IRB-2023-889
- A-8001599-00-00 (Altro numero di sovvenzione/finanziamento: National University Health System Seed Grant)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
The decision regarding sharing of de-identified individual participant data has not yet been finalized.
Data sharing will be considered following study completion, taking into account participant consent, ethical and regulatory requirements, institutional policies, and the potential risk of participant re-identification due to the relatively small sample size and specific study population.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .