NCT05864469

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

May 9, 2023

Last Update Submit

September 19, 2025

Conditions

Heart Failure

Keywords

dyadic copingpsychosocial intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

Secondary Outcomes (5)

  • Connor-Davidson Resilience Scale

    Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

  • Self-Compassion Scale Short Form

    Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

  • Minnesota Living with Heart Failure Questionnaire

    Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

  • Family Caregiver Quality of Life Scale

    Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

  • Hospital Anxiety and Depression Scale

    Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

Study Arms (2)

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.

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

Interventions

12-week psychosocial dyadic interventionOTHER

Comprising six weekly 60-min telephone-based sessions, followed by two weekly and two bi-weekly telephone follow-ups.

12-week psychosocial dyadic intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Can Xiong, PhD student

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

May 30, 2023

Primary Completion

February 2, 2025

Study Completion

February 2, 2025

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)