Construction and Application of a Self-Care Behavior Intervention Scheme for Chronic Heart Failure Patients Based on Interaction Model of Client Health Behavior

December 30, 2024 updated by: Zhi-fen Feng
The purpose of this study, which will last for 3 months, is to investigate the effect of the intervention based on the interaction model of health behavior on patients' disease perception, heart failure self-care level, quality of life and service satisfaction. If you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and care; The purpose of this study is to improve your level of self-care, prevent your readmission to the hospital, and do not harm your physical and mental health, nor negatively affect the patient's relationship with care; Your participation in the study and the personal data in the study are confidential, and any public report on the results of this study will not disclose your personal identity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • 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 Locations

  • China
    • Henan
      • Kaifeng, Henan, China, 475004
        • Institute of Nursing and Health, School of Nursing and Health,Henan University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with CHF according to the New York Heart Association (NYHA) functional classification of II-III.
  • Age ≥ 18 years, stable condition, clear consciousness, normal language and written expression abilities, no communication barriers, able to understand and accurately complete questionnaires.
  • Informed consent and voluntary participation.

Exclusion Criteria:

  • -Patients with complications such as renal or hepatic insufficiency, a history of mental disorders, or currently experiencing mental disorders, or critically ill.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
The control group received routine care.
Experimental: intervention group
The intervention group received the self-care behavior intervention program based on the interaction model of health behavior.
Behavioral: self-care behavior intervention
The intervention group received the self-care behavior intervention program based on the interaction model of health behavior

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chinese Version of the Self-Care of Heart Failure Index (SCHFI)
Time Frame: Baseline, one month and three months
Baseline, one month and three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Brief Illness Perception Questionnaire (BIPQ)
Time Frame: Baseline, one month and three months
Baseline, one month and three months
Minnesota Living with Heart Failure Quality of Life Questionnaire (MLHFQ)
Time Frame: Baseline, one month and three months
Baseline, one month and three months

Other Outcome Measures

Outcome Measure
Time Frame
Unplanned Readmission
Time Frame: one month and three months
one month and three months

Collaborators and Investigators

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

Sponsor

Zhi-fen Feng

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)

January 1, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUSOM2023-441

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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