A Psychosocial Dyadic Programme for Patients With Heart Failure and Their Family Caregivers

September 19, 2025 updated by: Can XIONG, The University of Hong Kong

The Effects of a Psychosocial Dyadic Intervention on the Mutuality, Psychological and Quality of Life Outcomes of Patients With Heart Failure and Their Family Caregivers: A Mixed-methods Study

The overall aim of the study is to evaluate the effects of a psychosocial dyadic intervention on mutuality, psychological strengths (i.e., resilience and self-compassion), psychological distress (i.e., anxiety and depression), and QoL outcomes of HF patients and caregivers. The HF patient-caregiver dyads will be randomly allocated to the intervention group to receive a 12-week relationship-focused psychosocial dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Heart failure (HF) is the terminal stage of various cardiovascular diseases. HF patient-caregiver dyads, who need to undertake the majority of HF care responsibility in the community, often experience a challenging adaptive process. There is a desperate need to develop and evaluate psychosocial dyadic interventions in HF patients and caregivers, as well as examine the working mechanism of such interventions. This sequential mixed-methods study consists of a single-blinded, two-arm randomized controlled trial (RCT) and a qualitative study. The dyads will be randomly allocated in a 1:1 ratio to the intervention group to receive a 12-week relationship-focused psychosocial dyadic programme, or to the control group to receive the usual care provided by the clinical team in the hospital. Besides, an empowerment-based approach will be employed in this programme to work together with patients and caregivers to set goals and develop an action plan to facilitate goal attainment. For the patients, Mutuality Scale, Connor-Davidson Resilience Scale, Self-Compassion Scale Short Form, Minnesota Living with Heart Failure Questionnaire, and Hospital Anxiety and Depression Scale will be administered at baseline, immediate and 3-month post-intervention. For the caregivers, the Mutuality Scale, Connor-Davidson Resilience Scale, Self-Compassion Scale Short Form, Family Caregiver Quality of Life Scale, and Hospital Anxiety and Depression Scale will be administered at baseline, immediate and 3-month post-intervention. A pilot study will be conducted to determine the feasibility, acceptability and preliminary effect of the intervention first. Afterwards, a full-scale mixed-methods study will be conducted to evaluate the effects of the intervention and the mechanism underlying the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients and caregivers aged 18 years or older
  • patients diagnosed with heart failure
  • able to identify one family caregiver who provides unpaid daily caregiving≥3.5hr/ day to participate
  • patients and caregivers able to read simplified Chinese and communicate in Mandarin
  • have access to a telephone at home.

Exclusion Criteria:

  • psychiatric problems requiring active treatment
  • other terminal illnesses, such as advanced cancer
  • with mechanical circulatory support, on the heart transplant list or with a history of heart transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 12-week psychosocial dyadic intervention
The 12-week psychosocial dyadic intervention will comprise six weekly 60-min telephone-based sessions, followed by two weekly and two bi-weekly telephone follow-ups.
Other: 12-week psychosocial dyadic intervention
Comprising six weekly 60-min telephone-based sessions, followed by two weekly and two bi-weekly telephone follow-ups.
No Intervention: Usual care
Participants in the control group will receive the usual care provided by the clinical team in the hospital

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mutuality Scale
Time Frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
The Mutuality Scale (MS, Chinese version) will be used to measure the relationship quality between HF patients and caregivers. The 15-item Mutuality Scale consists of four dimensions: love and affection, shared values, shared enjoyable activities, and reciprocity. The 5-point Likert-type scale from 0 (not at all) to 4 (quite a lot) is used, with higher scores indicating better relationship quality.
Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Connor-Davidson Resilience Scale
Time Frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
The 10-item Connor-Davidson Resilience Scale (CD-RISC, Chinese version) will be adopted to measure resilience in patients and caregivers. Each item is rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all the time). The scores range from 0 to 40, with higher values implying greater resilience.
Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Self-Compassion Scale Short Form
Time Frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
The 12-item Self-Compassion Scale Short Form (SCS-SF, Chinese version) will be used to measure self-compassion in patients and caregivers. Each item is rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always). The score ranges from 12 to 60, with higher scores indicating a higher level of self-compassion.
Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Minnesota Living with Heart Failure Questionnaire
Time Frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
The Chinese version of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) will be used to measure the disease-specific health-related QoL in HF patients. Patients respond to the 21 items using a 6-point Likert scale (0 = no; 5 = very much). The total score ranges from 0 to 105, with lower scores indicating better health-related QoL.
Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Family Caregiver Quality of Life Scale
Time Frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
The Chinese version of the Family Caregiver Quality of Life Scale (FAMQoL) will be adopted to measure the QoL in caregivers. The five-point Likert scale with replies ranging from "strongly disagree" to "strongly agree" is used. The total scores range from 16 to 80, and higher scores indicate better QoL.
Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Hospital Anxiety and Depression Scale
Time Frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate the psychological distress of patients and caregivers. The 4-point Likert scale from 0 (not a problem) to 3 (high level of problems) is applied. The higher scores in the two sub-scales indicate a more intensive anxious and depressed mood.
Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Can Xiong, PhD student, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW 23-226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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