Clinical trial NCT04917159: Acceptance and Commitment Therapy for Patients With Chronic Heart Failure and Their Caregivers on Their Quality of Life
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Chronic heart failure
Acceptance and Commitment Therapy
Patient-caregiver dyads
Health-related quality of life
Randomized controlled trial
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in patients' CHF specific health-related quality of life at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in patients' CHF specific health-related quality of life at 3-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in patients' generic health-related quality of life at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in patients' generic health-related quality of life at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in caregivers' health-related quality of life at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in caregivers' health-related quality of life at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
Secondary outcomes:
measure: Change from baseline in patients' unscheduled health service visits due to heart-related problems at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in patients' unscheduled health service visits due to heart-related problems at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in patients' CHF self-care behavior at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in patients' CHF self-care behavior at immediately post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in patients' smoking status at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in patients' smoking status at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in patients' alcohol status at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in patients' alcohol status at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in caregivers' perceived care burden at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in caregivers' perceived care burden at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in participants' anxiety symptoms at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in participants' depressive symptoms at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in participants' anxiety symptoms at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in participants' depressive symptoms at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in participants' perspective taking at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in participants' perspective taking at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in participants' psychological flexibility at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in participants' psychological flexibility at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in participants' relationship functioning at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in participants' relationship functioning at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in participants' generic health-related quality of life at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in participants' generic health-related quality of life at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
measure: Change from baseline in participants' self-compassion at immediately post-intervention
timeFrame: Baseline and post-intervention immediately
measure: Change from baseline in participants' self-compassion at three-month post-intervention
timeFrame: Baseline and three-month post-intervention
Other outcomes:
Locations:
city: Shiyan
country: China
facility: Taihe Hospital
state: Hubei
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Yim Wah Mak, PhD
role: PRINCIPAL_INVESTIGATOR
References: