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

NCT ID: NCT04917159

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2023-09-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ACT Group

The ACT intervention was structured to take place over one month on a weekly basis via Tencent's VooV platform. Each roughly 2-hour session will consist of a group-based ACT (1.5 hours) and a brief health education talk on CHF self-management (0.5 hours). Each training session will serve about 4-8 dyads. In addition, each participant will receive one set of session handouts on CHF education, ACT skills, and a homework assignment.

Group Type: EXPERIMENTAL

ACT (Acceptance and Commitment Therapy) plus brief CHF education

Intervention Type: BEHAVIORAL

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.

HE group

The participants of the control group will receive four weekly 2-hour sessions of structured health education on CHF self-management over four consecutive weeks via Tencent's VooV platform, delivered by a registered nurse. Each session will includea a review of the previous session (except the first session), a CHF education talk and a Q\&A section to evaluate the participant's understanding of the key concepts. Each session will be offered to 4-8 patient-caregiver dyads. In addition, each participant will receive session handouts on the main topic related to CHF self-management and homework assignments.

Group Type: ACTIVE_COMPARATOR

HE (Health Education)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patient

• 18 years or older
• a confirmed diagnosis of Chronic Heart Failure (CHF) according to international guidelines
• with New York Heart Association (NYHA) functional classification I to III
• has been hospitalized in the past one year
• able to nominate a primary family caregiver (if two or more family members where the primary caregivers of the patient, the one who had the highest average contact hours with the patient)
• can understand and communicate in Chinese
• can access Tencent VooV Meeting via smartphone for attending the intervention

• 18 years or older
• can understand and communicate in Chinese
• have been providing care to the patient for more than 14 hours per week for at least three consecutive months
• can access Tencent VooV Meeting via smartphone for attending the intervention

Exclusion Criteria

• has a documented medical history of psychiatric illness, dementia, and life-threatening, such as end-stage renal failure, severe pulmonary disease and respiratory disease
• has cognitive impairment evaluated with a score of 0-2 on the Mini-Cog scale
• living in a nursing home

2. Caregiver

• paid caregivers
• has a documented medical history of psychiatric illness, dementia, and life-threatening, such as end-stage renal failure, severe pulmonary disease and respiratory disease
• has cognitive impairment evaluated with a score of 0-2 on the Mini-Cog scale

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yim Wah Mak, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Locations

Taihe Hospital

Shiyan, Hubei, China

Countries

China

References

Zhang X, Ho GWK, Mak YW. Effectiveness of a videoconferencing group-based dyad acceptance and commitment therapy on the quality of life of chronic heart failure patients and their family caregivers: A study protocol for a randomized controlled trial. PLoS One. 2024 Apr 18;19(4):e0298178. doi: 10.1371/journal.pone.0298178. eCollection 2024.

Reference Type: DERIVED

PMID: 38635558 (View on PubMed)

Other Identifiers

PU001

Identifier Type: -

Identifier Source: org_study_id