A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults: a Three-arm Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- psychological distress
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
Controlled group will receive usual community service by nurse.
干预措施: usual service (Behavioral)
Caregiving training group
Caregiving training group will receive an evidence-based caregiving training via manual during nurse home visit.
干预措施: Evidence-based caregiving training (Behavioral)
Caregiving training group
Caregiving training group will receive an evidence-based caregiving training via manual during nurse home visit.
干预措施: usual service (Behavioral)
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
干预措施: Evidence-based caregiving training (Behavioral)
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
干预措施: family resilience intervention (Behavioral)
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
干预措施: usual service (Behavioral)
结局指标
主要结局
psychological distress
时间窗: 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.
caregiving ability
时间窗: 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.
family resilience
时间窗: 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.
次要结局
- Quality of life of caregiver(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 older adults(There will be 4 measurements, before, immediately after, 1-month, and 3-month after the intervention.)
- 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.)
研究者
Anni Wang
Associate Professor
Central South University