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Completed

NCT Number: NCT06522516

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

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, Fudan University

Shanghai, Shanghai Municipality, 20023, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

usual service

Behavioral

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

Primary outcomes

  1. family resilience

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

    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.

  2. psychological distress

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

    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.

  3. caregiving ability

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

    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.

Secondary outcomes

  1. caregiving burden

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

    The Zarit Burden Inventory (ZBI) is used to measure the caregiving burden of primary caregivers. This scale is a self-assessment scale consisting of two dimensions: personal burden and responsibility burden, with a total of 22 items. The Cronbach's alpha coefficient of this scale is 0.87.

  2. resilience

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

    The Connor Davidson Resilience Scale (CD-RISC) is used to assess the psychological resilience of primary caregivers.The Chinese version of CD-RISC includes 3 dimensions (resilience, strength, and optimism), 25 items, and is rated on a scale of 1-5, with higher scores indicating higher levels of psychological resilience. The Cronbach's alpha coefficient of the scale is 0.91, indicating good criterion related validity.

  3. coping

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

    Simplified Coping Style Questionnaire (SCSQ): used to assess the coping strategies of primary caregivers. This scale was developed by Jie Yaning in 1998. It includes two dimensions (positive coping and negative coping), with 20 items. The positive coping dimension includes items 1-12, and the negative coping dimension includes items 13-20. It is rated on a scale of 0-3 out of 4. The higher the total score of the positive dimension, the more likely the survey respondents are to adopt positive coping methods; The higher the total score of the negative coping dimension, the more inclined the survey respondents are to adopt negative coping strategies. The Cronbach's alpha coefficient of the positive coping style in this scale is 0.89, and the Cronbach's alpha coefficient of the negative coping style is 0.78.

  4. social support

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

    Perceived Social Support Scale (PSSS): used to measure the perceived level of social support among primary caregivers. This scale was developed by Zemit in 1987 and later translated into Chinese by Huang Li et al. and introduced into China. This scale consists of 3 dimensions (family support, friend support, and other support), with a total of 12 items. It uses a 7-point scoring system ranging from 1 to 7, with higher total scores indicating higher levels of social support. The Cronbach's alpha coefficient of this scale is 0.92, indicating good test-retest reliability and construct validity.

  5. Quality of life of caregiver

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

    The European Five Dimensional Five Level (EQ-5D-5L) health scale: used to measure the quality of life of disabled elderly and primary caregivers. This scale was developed by the European Society for Quality of Life and includes a brief descriptive system questionnaire and a visual analog scale. The Cronbach's alpha coefficient of this scale is 0.857, indicating good validity.

  6. Quality of life of older adults

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

    The European Five Dimensional Five Level (EQ-5D-5L) health scale: used to measure the quality of life of disabled elderly and primary caregivers. This scale was developed by the European Society for Quality of Life and includes a brief descriptive system questionnaire and a visual analog scale. The Cronbach's alpha coefficient of this scale is 0.857, indicating good validity.

Sponsors and collaborators

Lead sponsor

Central South University

Other

Collaborators

  • Fudan University

Registry information

Official study title

A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults: a Three-arm Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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