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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04917159
• Other study ID #: PU001
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: The Hong Kong Polytechnic University
• Contact: Yim Wah Mak, PhD
• Phone: (852) 2766-6421
• Email: yw.mak[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient-caregiver dyads will be recruited as units if both are eligible as listed below.

1. Patient

• Inclusion Criteria:

• 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

• 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

• Inclusion Criteria:

• 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:

• 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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Taihe Hospital	Shiyan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in patients' CHF specific health-related quality of life at immediately post-intervention	The short-form Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used for patients. KCCQ-12 is a 12-item instrument with a score of 0-100, a lower score indicates a poorer quality of life.	Baseline and post-intervention immediately
Primary	Change from baseline in patients' CHF specific health-related quality of life at 3-month post-intervention	The short-form Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used for patients. KCCQ-12 is a 12-item instrument with a score of 0-100, a lower score indicates a poorer quality of life.	Baseline and three-month post-intervention
Primary	Change from baseline in patients' generic health-related quality of life at immediately post-intervention	The five-dimensional descriptive system of the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate generic health-related quality of life for patients. The scores range from less than 0 to 1.0, with higher scores representing higher health utility.	Baseline and post-intervention immediately
Primary	Change from baseline in patients' generic health-related quality of life at three-month post-intervention	The five-dimensional descriptive system of the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate generic health-related quality of life for patients. The scores range from less than 0 to 1.0, with higher scores representing higher health utility.	Baseline and three-month post-intervention
Primary	Change from baseline in caregivers' health-related quality of life at immediately post-intervention	The five-dimensional descriptive system of the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate generic health-related quality of life for caregivers. The scores range from less than 0 to 1.0, with higher scores representing higher health utility.	Baseline and post-intervention immediately
Primary	Change from baseline in caregivers' health-related quality of life at three-month post-intervention	The five-dimensional descriptive system of the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate generic health-related quality of life for caregivers. The scores range from less than 0 to 1.0, with higher scores representing higher health utility.	Baseline and three-month post-intervention
Secondary	Change from baseline in patients' unscheduled health service visits due to heart-related problems at immediately post-intervention	Patients' report of the total number of unscheduled readmission and emergency visits due to heart-related problems in either a / public hospital(s) and/or a private hospital(s)	Baseline and post-intervention immediately
Secondary	Change from baseline in patients' unscheduled health service visits due to heart-related problems at three-month post-intervention	Patients' report of the total number of unscheduled readmission and emergency visits due to heart-related problems in either a / public hospital(s) and/or a private hospital(s)	Baseline and three-month post-intervention
Secondary	Change from baseline in patients' CHF self-care behavior at immediately post-intervention	The European Heart Failure Self-care Behavior Scale (EHFScBS) will be used for patients to evaluate their self-care behavior. EHFScBS is a 12-item 5-point Likert scale with a score ranging from 0 to 60, a lower score represents a higher level of self-care behaviors.	Baseline and post-intervention immediately
Secondary	Change from baseline in patients' CHF self-care behavior at immediately post-intervention	The European Heart Failure Self-care Behavior Scale (EHFScBS) will be used for patients to evaluate their self-care behavior. EHFScBS is a 12-item 5-point Likert scale with a score ranging from 0 to 60, a lower score represents a higher level of self-care behaviors.	Baseline and three-month post-intervention
Secondary	Change from baseline in patients' smoking status at immediately post-intervention	Patients' report of not having/ having smoked and the estimated amount of cigarette consumed (if applicable) for the past one week.	Baseline and post-intervention immediately
Secondary	Change from baseline in patients' smoking status at three-month post-intervention	Patients' report of not having/ having smoked and the estimated amount of cigarette consumed (if applicable) for the past one week.	Baseline and three-month post-intervention
Secondary	Change from baseline in patients' alcohol status at immediately post-intervention	Patients' report of not having/ having alcohol drinking and the estimated amount of alcohol consumed (if applicable) for the past one week.	Baseline and post-intervention immediately
Secondary	Change from baseline in patients' alcohol status at three-month post-intervention	Patients' report of not having/ having alcohol drinking and the estimated amount of alcohol consumed (if applicable) for the past one week.	Baseline and three-month post-intervention
Secondary	Change from baseline in caregivers' perceived care burden at immediately post-intervention	The Zarit Caregiver Burden Interview (ZBI) will be used for caregivers to evaluate perceived care burden. ZBI is a 22-item 5-point Likert scale with a score ranging from 0 to 88, a lower score indicates less care burden.	Baseline and post-intervention immediately
Secondary	Change from baseline in caregivers' perceived care burden at three-month post-intervention	The Zarit Caregiver Burden Interview (ZBI) will be used for caregivers to evaluate perceived care burden. ZBI is a 22-item 5-point Likert scale with a score ranging from 0 to 88, a lower score indicates less care burden.	Baseline and three-month post-intervention
Secondary	Change from baseline in participants' anxiety symptoms at immediately post-intervention	The General Anxiety Disorder Scale (GAD) will be used for caregivers and patients. The GAD consists of 7 item 4-point Likert scale. The score of each scale ranges from 0 to 21, with a lower score indicating a lower level of anxiety.	Baseline and post-intervention immediately
Secondary	Change from baseline in participants' depressive symptoms at immediately post-intervention	The Patient Health Questionaire (PHQ) will be used for caregivers and patients. The PHQ consists of 9 item 4-point Likert scale. The score of each scale ranges from 0 to 27, with a lower score indicating a lower level of depression.	Baseline and post-intervention immediately
Secondary	Change from baseline in participants' anxiety symptoms at three-month post-intervention	The General Anxiety Disorder Scale (GAD) will be used for caregivers and patients. The GAD consists of 7 item 4-point Likert scale. The score of each scale ranges from 0 to 21, with a lower score indicating a lower level of anxiety.	Baseline and three-month post-intervention
Secondary	Change from baseline in participants' depressive symptoms at three-month post-intervention	The Patient Health Questionaire (PHQ) will be used for caregivers and patients. The PHQ consists of 9 item 4-point Likert scale. The score of each scale ranges from 0 to 27, with a lower score indicating a lower level of depression.	Baseline and three-month post-intervention
Secondary	Change from baseline in participants' perspective taking at immediately post-intervention	The perspective taking subscale from the Interpersonall Reactivity Index (IRI) will be used for caregivers and patients. Chinese version of the perspective taking subscale is a 5-item 5-point Likert scale with a score ranging from 5 to 25, a lower score represents a lower tendency for perspective taking.	Baseline and post-intervention immediately
Secondary	Change from baseline in participants' perspective taking at three-month post-intervention	The perspective taking subscale from the Interpersonall Reactivity Index (IRI) will be used for caregivers and patients. Chinese version of the perspective taking subscale is a 5-item 5-point Likert scale with a score ranging from 5 to 25, a lower score represents a lower tendency for perspective taking.	Baseline and three-month post-intervention
Secondary	Change from baseline in participants' psychological flexibility at immediately post-intervention	The Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT) will be used for caregivers and patients.CompACT is an 18-item 5-point Likert scale with a score ranging from 18 to 90, a lower score represents a lower level of psychological flexibility.	Baseline and post-intervention immediately
Secondary	Change from baseline in participants' psychological flexibility at three-month post-intervention	The Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT) will be used for caregivers and patients.CompACT is an 18-item 5-point Likert scale with a score ranging from 18 to 90, a lower score represents a lower level of psychological flexibility.	Baseline and three-month post-intervention
Secondary	Change from baseline in participants' relationship functioning at immediately post-intervention	The Dyadic Adjustment Scale-7(DAS-7) will be used for caregivers and patients.DAS-7 is a 7-item 6-point Likert scale with a score ranging from 0 to 36, a lower score represents less positive relationship quality.	Baseline and post-intervention immediately
Secondary	Change from baseline in participants' relationship functioning at three-month post-intervention	The Dyadic Adjustment Scale-7(DAS-7) will be used for caregivers and patients.DAS-7 is a 7-item 6-point Likert scale with a score ranging from 0 to 36, a lower score represents less positive relationship quality.	Baseline and three-month post-intervention
Secondary	Change from baseline in participants' generic health-related quality of life at immediately post-intervention	The visual analog scale (VAS) of EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate participants' perceived health, the score ranges from 0 to 100 with 100 being better.	Baseline and post-intervention immediately
Secondary	Change from baseline in participants' generic health-related quality of life at three-month post-intervention	The visual analog scale (VAS) of EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate participants' perceived health, the score ranges from 0 to 100 with 100 being better.	Baseline and three-month post-intervention
Secondary	Change from baseline in participants' self-compassion at immediately post-intervention	The Self-compassion Scale (SCS) will be used for caregivers and patients.SCS is an 12-item 5-point Likert scale with a score ranging from 12 to 60, a lower score represents a lower level of self-compassion.	Baseline and post-intervention immediately
Secondary	Change from baseline in participants' self-compassion at three-month post-intervention	The Self-compassion Scale (SCS) will be used for caregivers and patients.SCS is an 12-item 5-point Likert scale with a score ranging from 12 to 60, a lower score represents a lower level of self-compassion.	Baseline and three-month post-intervention