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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- The University of Hong Kong
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- Mutuality Scale
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Can XIONG
Principal Investigator
The University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Mutuality Scale
Time Frame: 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.
Secondary Outcomes
- 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))