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

NCT06522516 | Completed

• 1 other identifier: A family resilience program
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caregiver Burden

Keywords

family resilience; caregiver; distress; older adults

Outcome Measures

Primary Outcomes (3)

• family resilience

  The Walsh Family Resilience Questionnaire Chinese Version (WFRQ-C) is used to measure the level of family resilience of primary caregivers. The questionnaire includes three dimensions and 26 items: family beliefs, communication and resolution, and external support. The questionnaire items are evaluated using a Likert 5-point rating system, with scores ranging from 1 to 5 from "never" to "always". The higher the score, the higher the level of family resilience. The Cronbach's alpha coefficient of the questionnaire is 0.93, with a test-retest reliability of 0.96, indicating good validity.

  There will be 4 measurements, before, immediately after and，1-month, 3-month after the intervention.

• psychological distress

  Distress thermometer (DT): used to assess the level of psychological distress of primary caregivers. This scale was designed by Roth and translated into China by Tang Lili et al. in 2011. DT is a visual analog scale scale ranging from 0 to 10 points (0 indicates no psychological distress, 10 indicates extreme psychological distress). The reliability of the Chinese version DT retest is r=0.80, and the calibration validity is good.

  There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.

• caregiving ability

  Caregiver Task Inventory (FCTI): used to measure the caregiving ability of primary caregivers. This scale consists of 5 dimensions (adapting to caregiver roles, responding to needs and providing assistance, handling personal emotions, evaluating family and community resource professionals, and adjusting life to meet caregiving needs), with a total of 25 items.The total score is 50 points, with higher scores indicating more caregiving difficulties for caregivers. The Cronbach's alpha coefficient of the scale is 0.93, indicating good construct validity.

  There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.

Secondary Outcomes (6)

• caregiving burden

  There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.

• resilience

  There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.

• coping

  There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.

• social support

  There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.

• Quality of life of caregiver

  There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.

Study Arms (3)

Caregiving training group

EXPERIMENTAL

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

Behavioral: Evidence-based caregiving training; Behavioral: usual service

Caregiving training plus family resilience group

EXPERIMENTAL

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

Behavioral: Evidence-based caregiving training; Behavioral: family resilience intervention; Behavioral: usual service

Control group

ACTIVE COMPARATOR

Controlled group will receive usual community service by nurse.

Behavioral: usual service

Interventions

Evidence-based caregiving training 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.

Caregiving training group; Caregiving training plus family resilience group

family resilience intervention 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.

Caregiving training plus family resilience group

usual service BEHAVIORAL

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

Caregiving training group; Caregiving training plus family resilience group; Control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead
• Fudan University: collaborator

Study Sites (1)

School of Nursing, Fudan University

Shanghai, Shanghai Municipality, 20023, China

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 2 intervention groups.

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 26, 2024
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CN (1)