Clinical trial NCT05864469: A Psychosocial Dyadic Programme for Patients With Heart Failure and Their Family Caregivers
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: dyadic coping
psychosocial intervention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Mutuality Scale
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Secondary outcomes:
measure: Connor-Davidson Resilience Scale
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
measure: Self-Compassion Scale Short Form
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
measure: Family Caregiver Quality of Life Scale
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
measure: Hospital Anxiety and Depression Scale
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: The University of Hong Kong
name: Can Xiong, PhD student
role: PRINCIPAL_INVESTIGATOR
References: