The Effects of a Psychosocial Dyadic Intervention on the Mutuality, Psychological and Quality of Life Outcomes of Patients With Heart Failure and Their Family Caregivers: A Mixed-methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Mutuality Scale
研究概览
简要总结
The overall aim of the study is to evaluate the effects of a psychosocial dyadic intervention on mutuality, psychological strengths (i.e., resilience and self-compassion), psychological distress (i.e., anxiety and depression), and QoL outcomes of HF patients and caregivers. The HF patient-caregiver dyads will be randomly allocated to the intervention group to receive a 12-week relationship-focused psychosocial dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital.
详细描述
Heart failure (HF) is the terminal stage of various cardiovascular diseases. HF patient-caregiver dyads, who need to undertake the majority of HF care responsibility in the community, often experience a challenging adaptive process. There is a desperate need to develop and evaluate psychosocial dyadic interventions in HF patients and caregivers, as well as examine the working mechanism of such interventions. This sequential mixed-methods study consists of a single-blinded, two-arm randomized controlled trial (RCT) and a qualitative study. The dyads will be randomly allocated in a 1:1 ratio to the intervention group to receive a 12-week relationship-focused psychosocial dyadic programme, or to the control group to receive the usual care provided by the clinical team in the hospital. Besides, an empowerment-based approach will be employed in this programme to work together with patients and caregivers to set goals and develop an action plan to facilitate goal attainment. For the patients, Mutuality Scale, Connor-Davidson Resilience Scale, Self-Compassion Scale Short Form, Minnesota Living with Heart Failure Questionnaire, and Hospital Anxiety and Depression Scale will be administered at baseline, immediate and 3-month post-intervention. For the caregivers, the Mutuality Scale, Connor-Davidson Resilience Scale, Self-Compassion Scale Short Form, Family Caregiver Quality of Life Scale, and Hospital Anxiety and Depression Scale will be administered at baseline, immediate and 3-month post-intervention. A pilot study will be conducted to determine the feasibility, acceptability and preliminary effect of the intervention first. Afterwards, a full-scale mixed-methods study will be conducted to evaluate the effects of the intervention and the mechanism underlying the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •patients and caregivers aged 18 years or older
- •patients diagnosed with heart failure
- •able to identify one family caregiver who provides unpaid daily caregiving≥3.5hr/ day to participate
- •patients and caregivers able to read simplified Chinese and communicate in Mandarin
- •have access to a telephone at home.
排除标准
- •psychiatric problems requiring active treatment
- •other terminal illnesses, such as advanced cancer
- •with mechanical circulatory support, on the heart transplant list or with a history of heart transplant
研究组 & 干预措施
12-week psychosocial dyadic intervention
The 12-week psychosocial dyadic intervention will comprise six weekly 60-min telephone-based sessions, followed by two weekly and two bi-weekly telephone follow-ups.
干预措施: 12-week psychosocial dyadic intervention (Other)
Usual care
Participants in the control group will receive the usual care provided by the clinical team in the hospital
结局指标
主要结局
Mutuality Scale
时间窗: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
The Mutuality Scale (MS, Chinese version) will be used to measure the relationship quality between HF patients and caregivers. The 15-item Mutuality Scale consists of four dimensions: love and affection, shared values, shared enjoyable activities, and reciprocity. The 5-point Likert-type scale from 0 (not at all) to 4 (quite a lot) is used, with higher scores indicating better relationship quality.
次要结局
- Connor-Davidson Resilience Scale(Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up))
- Hospital Anxiety and Depression Scale(Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up))
- Family Caregiver Quality of Life Scale(Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up))
- Self-Compassion Scale Short Form(Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up))
- Minnesota Living with Heart Failure Questionnaire(Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up))
研究者
Can XIONG
Principal Investigator
The University of Hong Kong