Heart FailureNCT05864469
A Psychosocial Dyadic Programme for Patients With Heart Failure and Their Family Caregivers
A study testing 12-week psychosocial dyadic intervention in people with Heart Failure, run by The University of Hong Kong at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- 12-week psychosocial dyadic intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 2 Feb 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Union hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- 12-week psychosocial dyadic intervention
- Keywords
- dyadic coping, psychosocial intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week psychosocial dyadic interventionOther
Comprising six weekly 60-min telephone-based sessions, followed by two weekly and two bi-weekly telephone follow-ups.
| Study group | Role | What they receive |
|---|---|---|
| 12-week psychosocial dyadic intervention | Experimental | 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. Receives: Other: 12-week psychosocial dyadic intervention |
| Usual care | No intervention | Participants in the control group will receive the usual care provided by the clinical team in the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutuality Scale
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.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Secondary outcomes (5)
Connor-Davidson Resilience Scale
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.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Self-Compassion Scale Short Form
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.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Minnesota Living with Heart Failure Questionnaire
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.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Family Caregiver Quality of Life Scale
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.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Hospital Anxiety and Depression Scale
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.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start30 May 2023
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can XIONG, The University of Hong Kong
- Investigators
- Can Xiong, PhD student, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864469
- Sponsor's protocol ID
- UW 23-226
- Status last verified
- Sep 2025
- First submitted
- 9 May 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05864469
- Acronym / sponsor ID
- UW 23-226
- Conditions
- Heart Failure
- Keywords
- dyadic coping, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 18 May 2023 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-week psychosocial dyadic intervention | Experimental | Other: 12-week psychosocial dyadic interventionThe 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. |
| Usual care | No intervention | –Participants in the control group will receive the usual care provided by the clinical team in the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| 12-week psychosocial dyadic interventionComprising six weekly 60-min telephone-based sessions, followed by two weekly and two bi-weekly telephone follow-ups. | Other | 12-week psychosocial dyadic intervention |
Primary outcome
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.
5 secondary outcomes
Connor-Davidson Resilience Scale
Time frame: 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)
Minnesota Living with Heart Failure Questionnaire
Time frame: 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)
Hospital Anxiety and Depression Scale
Time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
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 24 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Can Xiong, PhD student principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week psychosocial dyadic intervention in people with Heart Failure, run by The University of Hong Kong 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 5 inclusion and 3 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 24 Sep 2025. 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?
Mutuality Scale (time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2025.