NCT06779227

Brief Summary

This study lasted for a total of three months. The purpose is to build a hospital-family transitional nursing intervention program for patients with chronic heart failure, and to explore the effectiveness of the program on the self-management of patients with chronic heart failure, in order to provide certain empirical research for the clinical intervention of transitional nursing for patients with chronic heart failure. If you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and nursing. The purpose of this study is to improve your self-care level and prevent your re-admission. It will not harm your physical and mental health and will not have a negative impact on the relationship between patients and nursing. You participate in this study and The personal data in the study is confidential, and any public report on the results of this study will not disclose your personal identity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
Last Updated

January 16, 2025

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

December 30, 2024

Last Update Submit

January 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-efficacy management indicators

    The measurement tool adopts the Chronic Disease Self-Efficacy Questionnaire compiled by Stanford University in the United States.The scoring consists of two dimensions: symptom management and disease-commonality management. The self-efficacy score for symptom management is calculated by averaging items 1, 2, 3, and 4 (if two or more items are missing or omitted, the variable is considered missing). A higher score indicates greater self-efficacy in symptom management. The self-efficacy score for disease-commonality management is obtained by averaging items 5 and 6. The score ranges from 1 to 5, a higher score indicates higher self-efficacy in disease-commonality management.

    Baseline, one month, three months

Secondary Outcomes (3)

  • Self-care indicators

    Baseline, one month, three months

  • Disease-related indicators

    Baseline, one month, three months

  • Transitional nursing evaluation indicators

    Baseline, one month, three months

Other Outcomes (1)

  • Re-hospitalisation indicators

    Baseline, one month, three months

Study Arms (2)

control group

NO INTERVENTION

The control group received routine care.

Intervention group

EXPERIMENTAL

The intervention group received a transitional care intervention mainly focused on the transitional care model (TCM).

Behavioral: Hospital family transitional nursing intervention

Interventions

The intervention group received a transitional care intervention mainly focused on the transitional care model (TCM).

Intervention group

Eligibility Criteria

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

You may qualify if:

  • It meets the diagnostic criteria of the New York Heart Association (NYHA) for CHF, and the heart function level is II to III;
  • Age ≥18 years old;
  • The condition is stable and meets the standard of being discharged from the hospital;
  • Clear consciousness, no communication barriers, able to understand and fill in the questionnaire correctly;
  • Informed consent and voluntary participation in this study.

You may not qualify if:

  • Patients with hepato-renal disfunction, sequelae of stroke, dementia;
  • Patients with a history of mental disorders or already having mental disorders, critically ill patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nursing and Health, School of Nursing and Health, Henan University

Kaifeng, Henan, 475004, China

Location

Related Publications (1)

  • Feng ZF, Liu Y, Salvador JT, Ala MB, Nery MAC, Huang XY, Zhang L, Liu S. Implementation and evaluation of hospital-to-home transitional care intervention in patients with chronic heart failure. BMC Nurs. 2025 Jul 1;24(1):717. doi: 10.1186/s12912-025-03447-5.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, School of Nursing and Health, Henan University

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 16, 2025

Study Start

October 15, 2021

Primary Completion

June 20, 2022

Study Completion

December 25, 2022

Last Updated

January 16, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations