A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults

NCT ID: NCT06522516

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-30

Brief Summary

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This is a 3-arm controlled trial. The participants are caregivers of the community-dwelling dependent older adults. There will be around 105 participants to be recruited and randomly allocated into 3 groups. Caregiving training group will receive a evidence-based caregiving training delivered via home visit of community nurse. Caregiving training plus family resilience group will additionally receive a structured family resilience intervetion. Control group will receive usual community health care service by nurses. The primary outcomes are caregiving ability, family resilience and psychological distress, and the secondary outcomes are caregiving burden, resilience, coping, social support, and quality of life the caregivers and the older adults. The measurement will be conducted four times at baseline, after, 1-month and 3-month after intervention.

Detailed Description

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Conditions

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Caregiver Burden

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 intervention groups.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Caregiving training group

Caregiving training group will receive an evidence-based caregiving training via manual during nurse home visit.

Group Type EXPERIMENTAL

Evidence-based caregiving training

Intervention Type BEHAVIORAL

This is designed based on evidence of daily living activity ability caregiving, including① Dietary training: guiding caregivers to choose appropriate tableware according to the functional status of disabled elderly people, and training them in eating posture such as changing positions and using tableware; ② Dressing training: guide caregivers to train disabled elderly people on how to put on and take off clothes, shoes, socks, etc.; ③ Personal hygiene training: including washing face, hands, brushing teeth, etc.; ④ Excretion function training: including urination function training and defecation function training; ⑤ Mobile training: including support walking training, cane walking training, etc.; ⑥ Wheelchair training: Guide caregivers to use wheelchairs according to the specific situation of disabled elderly people.

usual service

Intervention Type BEHAVIORAL

This means the usual service provided by the local community health center from nurses during bi-weekly home visit.

Caregiving training plus family resilience group

Caregiving training plus family resilience group will receive an evidence-based caregiving training and family resilience psychological intervention via manual during nurse home visit

Group Type EXPERIMENTAL

Evidence-based caregiving training

Intervention Type BEHAVIORAL

This is designed based on evidence of daily living activity ability caregiving, including① Dietary training: guiding caregivers to choose appropriate tableware according to the functional status of disabled elderly people, and training them in eating posture such as changing positions and using tableware; ② Dressing training: guide caregivers to train disabled elderly people on how to put on and take off clothes, shoes, socks, etc.; ③ Personal hygiene training: including washing face, hands, brushing teeth, etc.; ④ Excretion function training: including urination function training and defecation function training; ⑤ Mobile training: including support walking training, cane walking training, etc.; ⑥ Wheelchair training: Guide caregivers to use wheelchairs according to the specific situation of disabled elderly people.

family resilience intervention

Intervention Type BEHAVIORAL

The intervention will be developed based on the Maccubbin Family Resilience Theory, and Delphi methods. The content will contain 8 topics and be incorporated into caregiving training manual.

usual service

Intervention Type BEHAVIORAL

This means the usual service provided by the local community health center from nurses during bi-weekly home visit.

Control group

Controlled group will receive usual community service by nurse.

Group Type ACTIVE_COMPARATOR

usual service

Intervention Type BEHAVIORAL

This means the usual service provided by the local community health center from nurses during bi-weekly home visit.

Interventions

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Evidence-based caregiving training

This is designed based on evidence of daily living activity ability caregiving, including① Dietary training: guiding caregivers to choose appropriate tableware according to the functional status of disabled elderly people, and training them in eating posture such as changing positions and using tableware; ② Dressing training: guide caregivers to train disabled elderly people on how to put on and take off clothes, shoes, socks, etc.; ③ Personal hygiene training: including washing face, hands, brushing teeth, etc.; ④ Excretion function training: including urination function training and defecation function training; ⑤ Mobile training: including support walking training, cane walking training, etc.; ⑥ Wheelchair training: Guide caregivers to use wheelchairs according to the specific situation of disabled elderly people.

Intervention Type BEHAVIORAL

family resilience intervention

The intervention will be developed based on the Maccubbin Family Resilience Theory, and Delphi methods. The content will contain 8 topics and be incorporated into caregiving training manual.

Intervention Type BEHAVIORAL

usual service

This means the usual service provided by the local community health center from nurses during bi-weekly home visit.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* ①The degree of disability of the caregiver is moderate to severe activity of daily living score above;

* The primary caregivers are≥18 years old ;

* The primary caregivers bear the most important care task during care, and the continuous care time are≥3 months ; -④The psychological pain thermometer score of the primary caregivers are≥5 points (the previous cross-sectional survey results showed that when the psychological pain thermometer score of the primary caregivers in disabled elderly are 5 points, the highest Youden index is obtained, and the sensitivity, specificity, positive predictive value, and negative predictive value are also high. Therefore, participants with scores above 5 points are screened as potential research subjects ); -⑤No cognitive impairment or language expression disorders; -⑥The primary caregivers have smart phones and can use them skillfully, and have access to the Internet; -⑦Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria

* ①Currently participating or having received intervention from other healthcare teams within the past three months;

* There are paid personnel such as nannies participating in the care.

* Those who voluntarily withdrew from the research process;

* During the research process, due to significant adverse events (such as death) involving disabled elderly individuals or primary caregivers, they were unable to continue participating in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role lead

Responsible Party

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Anni Wang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Nursing, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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A family resilience program

Identifier Type: -

Identifier Source: org_study_id

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