Chronic Heart FailureNCT04917159
Acceptance and Commitment Therapy for Patients With Chronic Heart Failure and Their Caregivers on Their Quality of Life
A study testing ACT (Acceptance and Commitment Therapy) plus brief CHF education and HE (Health Education) in people with Chronic Heart Failure, run by The Hong Kong Polytechnic University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- ACT (Acceptance and Commitment Therapy) plus brief CHF education and HE (Health Education)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2022to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- ACT (Acceptance and Commitment Therapy) plus brief CHF education, HE (Health Education)
- Keywords
- Chronic heart failure, Acceptance and Commitment Therapy, Patient-caregiver dyads, Health-related quality of life, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT (Acceptance and Commitment Therapy) plus brief CHF educationBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT Group | Experimental | 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. Receives: Behavioral: ACT (Acceptance and Commitment Therapy) plus brief CHF education |
| HE group | Active comparator | 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. Receives: Behavioral: HE (Health Education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
Secondary outcomes (24)
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)
Measured: Baseline and post-intervention immediately
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)
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
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.
Measured: Baseline and post-intervention immediately
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.
Measured: Baseline and three-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start10 Jun 2022
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yim Wah Mak, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917159
- Sponsor's protocol ID
- PU001
- Status last verified
- May 2022
- First submitted
- 26 May 2021
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38635558
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04917159
- Acronym / sponsor ID
- PU001
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic heart failure, Acceptance and Commitment Therapy, Patient-caregiver dyads, Health-related quality of life, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT Group | Experimental | Behavioral: ACT (Acceptance and Commitment Therapy) plus brief CHF educationThe 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. |
| HE group | Active comparator | Behavioral: HE (Health Education)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
Key exclusion criteria (7 listed)
- Caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT (Acceptance and Commitment Therapy) plus brief CHF educationThe 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. | Behavioural | ACT Group |
| 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. | Behavioural | HE group |
Primary outcome
Change from baseline in patients' CHF specific health-related quality of life at immediately post-intervention
Time frame: Baseline and post-intervention immediately
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.
Change from baseline in patients' CHF specific health-related quality of life at 3-month post-intervention
Time frame: Baseline and three-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.
Change from baseline in patients' generic health-related quality of life at immediately post-intervention
Time frame: Baseline and post-intervention immediately
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.
Change from baseline in patients' generic health-related quality of life at three-month post-intervention
Time frame: Baseline and 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.
Change from baseline in caregivers' health-related quality of life at immediately post-intervention
Time frame: Baseline and post-intervention immediately
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.
Change from baseline in caregivers' health-related quality of life at three-month post-intervention
Time frame: Baseline and 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.
24 secondary outcomes
Change from baseline in patients' unscheduled health service visits due to heart-related problems at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in patients' unscheduled health service visits due to heart-related problems at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in patients' CHF self-care behavior at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in patients' CHF self-care behavior at immediately post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in patients' smoking status at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in patients' smoking status at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in patients' alcohol status at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in patients' alcohol status at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in caregivers' perceived care burden at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in caregivers' perceived care burden at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in participants' anxiety symptoms at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in participants' depressive symptoms at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in participants' anxiety symptoms at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in participants' depressive symptoms at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in participants' perspective taking at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in participants' perspective taking at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in participants' psychological flexibility at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in participants' psychological flexibility at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in participants' relationship functioning at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in participants' relationship functioning at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in participants' generic health-related quality of life at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in participants' generic health-related quality of life at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Change from baseline in participants' self-compassion at immediately post-intervention
Time frame: Baseline and post-intervention immediately
Change from baseline in participants' self-compassion at three-month post-intervention
Time frame: Baseline and three-month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Derived from this study: PubMed 38635558Zhang 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.
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Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yim Wah Mak, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT (Acceptance and Commitment Therapy) plus brief CHF education and HE (Health Education) in people with Chronic Heart Failure, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in patients' CHF specific health-related quality of life at immediately post-intervention (time frame: Baseline and post-intervention immediately). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.