Clinical trial NCT06522516: A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults
Official title: A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults: a Three-arm Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burden
Keywords: family resilience
caregiver
distress
older adults
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2024-07-26
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 intervention groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: family resilience
timeFrame: There will be 4 measurements, before, immediately after and，1-month, 3-month after the intervention.
measure: psychological distress
timeFrame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
measure: caregiving ability
timeFrame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
Secondary outcomes:
measure: caregiving burden
timeFrame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
measure: resilience
timeFrame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
measure: coping
timeFrame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
measure: social support
timeFrame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
measure: Quality of life of caregiver
timeFrame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
measure: Quality of life of older adults
timeFrame: There will be 4 measurements, before, immediately after, 1-month, and 3-month after the intervention.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: School of Nursing, Fudan University
state: Shanghai
Study officials:
References: