NCT06759987

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

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

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
Last Updated

January 6, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 30, 2024

Last Update Submit

December 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chinese Version of the Self-Care of Heart Failure Index (SCHFI)

    Baseline, one month and three months

Secondary Outcomes (2)

  • Brief Illness Perception Questionnaire (BIPQ)

    Baseline, one month and three months

  • Minnesota Living with Heart Failure Quality of Life Questionnaire (MLHFQ)

    Baseline, one month and three months

Other Outcomes (1)

  • Unplanned Readmission

    one month and three months

Study Arms (2)

control group

NO INTERVENTION

The control group received routine care.

intervention group

EXPERIMENTAL

The intervention group received the self-care behavior intervention program based on the interaction model of health behavior.

Behavioral: self-care behavior intervention

Interventions

The intervention group received the self-care behavior intervention program based on the interaction model of health behavior

intervention group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

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

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

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

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 6, 2025

Study Start

January 1, 2023

Primary Completion

June 30, 2023

Study Completion

October 31, 2023

Last Updated

January 6, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations