NCT04917159

Acceptance and Commitment Therapy for Patients With Chronic Heart Failure and Their Caregivers on Their Quality of Life

Effectiveness of Acceptance and Commitment Therapy on the Health-related Quality of Life in Patients With Chronic Heart Failure and Their Family Caregivers: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is to examine whether group-based Acceptance and Commitment Therapy in the patient-caregiver dyads with Chronic Heart Failure is effective in improving dyadic health-related quality of life, dyadic psychological symptoms, caregiver burden, the rate of patient's readmission, and patient's self-care behavior in comparison with those dyads receiving health education over three-month post intervention.

Detailed description

Chronic heart failure (CHF) is a complex progressive debilitating illness characterized by high morbidity and mortality with unpredictable course and frequent hospital readmissions. Patients with CHF are often old with comorbid impaired psychosocial functioning, and worse health-related quality of life (HRQoL), which generate unavoidable increased dependence on their family caregivers at home. The family caregivers often bear physical and psychological challenges with declined HRQoL, maintaining interdependent relationships with their care recipient when participating in CHF self-management. Dyadic interventions delivered to the patients along with their family caregivers are successful to facilitate patients' self-management to reduce patients' hospital readmission rates and improve HRQoL for both patients and their caregivers post-discharge in the context of chronic disease management. However, little attention has been paid to this vulnerable group. It is noteworthy that a transdiagnostic psychological approach, Acceptance and Commitment Therapy (ACT), aiming to promote psychological flexibility, has demonstrated an ability to break through the psychological barriers to meaningful living among clinical and non-clinical populations. Existing evidence shows promising improvements of ACT on HRQoL in both patients with chronic illness and the family caregivers of the patients with childhood illness. Such evidence implies that ACT in the patient-caregiver dyads may be beneficial for HRQoL and other health outcomes for both patients with CHF and their family caregivers. However, little has been done to address these concerns in mainland China. A pilot testing was to evaluate the feasibility of recruiting participants at the clinical setting and the acceptability of group-based ACT to patient-caregiver dyads with CHF. Then, a pragmatic, single-center, two-arm, parallel (in 1:1 ratio) randomized controlled trial (RCT) will be performed to examine the effects of acceptance and commitment therapy in patient-caregiver dyads with CHF. Eligible patient-caregiver dyads will be randomly assigned to either the intervention group or the control group. Assessments will be conducted before the intervention, immediately post-intervention, and 3-month post-intervention by blind outcome assessors. The ACT intervention will be delivered by two facilitators and continually supervised by an experienced ACT researcher.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	ACT (Acceptance and Commitment Therapy) plus brief CHF education	The participants will identify their values and clarify their alternative behavior, exploring their thoughts and feelings, and finding ways to meet their own and their family member's needs. The rational bond between the patient and his/her family caregiver will be emphasized. In addtion, the contents of brief CHF education are based on the latest national clinical practice guideline for CHF, including symptoms monitoring, medication adherence, fluid and salt restriction, smoking cessation, alcohol consumption, and physical activity maintenance.
BEHAVIORAL	HE (Health Education)	The educational contents are based on the latest national clinical practice guideline for CHF. Besides the basic information on CHF education provided in intervention group, the contents of CHF education also include definition of CHF, epidemiology, diagnosis, comorbidity, and CHF treatment. ACT components are not covered.

Timeline

• Start date: 2022-06-10
• Primary completion: 2023-09-14
• Completion: 2023-09-14
• First posted: 2021-06-08
• Last updated: 2024-08-29

Locations

1 site across 1 country: China