Implementation and Evaluation of Hospital-to-Home Transitional Care Intervention in Patients with Chronic Heart Failure

Implementation Ond Evaluation of Hospital-to-Home Transitional Care Intervention in Patients with Chronic Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Behavioral: Hospital family transitional nursing intervention

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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 a transitional care intervention mainly focused on the transitional care model (TCM).	Behavioral: Hospital family transitional nursing intervention; The intervention group received a transitional care intervention mainly focused on the transitional care model (TCM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-care indicators	In this study, the Chinese version of the self-care ability scale for elderly, translated by Guo , was used. The scale demonstrates good reliability and validity, with a Cronbach's α coefficient of 0.82, a test-retest reliability of 0.82, and a content validity index of 0.94. The scale consists of 17 items and is applicable to all older adults. Scoring on the scale ranges from "completely disagree" to "completely agree," with scores ranging from 1 to 5. Higher scores indicate a higher self-care ability in older adults.	Baseline, one month, three months
Disease-related indicators	Disease-related indicators are the indicators of frequent examination of patients with heart failure in the hospital: The blood test index adopts NT-proBNP as a measurement indicator, which is an independent risk factor for the death and re-admission of patients with heart failure. Due to structure and metabolism, NT-pro BNP has the advantages of long half-life (120min), high blood concentration, low individual variability rate, good in vitro stability, not limited by specimen collection conditions and the influence of specimen type (plasma or serum). NT-pro BNP testing on patients can help assess long-term risks. Repeated determination will provide more prognostic information for patients.	Baseline, one month, three months
Transitional nursing evaluation indicators	This study adopts the Care Transitions Measure (CTM-15) developed by American scholar COLEMAN in 2002. This scale is a self-assessment scale that evaluates transitional care from the patient's perspective, including information transmission ( 6 items), patient participation (3 entries), management preparation (4 entries), nursing plan (2 entries) 4 dimensions, a total of 15 entries. The results show that the total scale Cronbach's α coefficient is 0.93, and the content validity index is 0.99, which has good credibility. The scores of each item: "very disagree", "disagree", "agree" and "very agree" are 1~4 points respectively, and the final score is converted to 0~100 points. The higher the score, indicating that the research subjects are satisfied with the transitional nursing services.	Baseline, one month, three months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-hospitalisation indicators	The study mainly measures the re-hospitalisation of the study subjects and whether the re-hospitalisation rate of the two groups has changed. By counting the re-admission of the study subjects, the re-admission rate of the two groups is calculated, which is mainly collected through the combination of the hospital's HIS system inquiry and asking patients or family members. HIS's scoring adopts the method of multi-dimensional evaluation. Each dimension contains multiple items, and each item has a corresponding scoring standard. The scoring generally adopts the five-level method, from 0 to 4 points, indicating no impact, mild impact, moderate impact, severe impact and very serious impact respectively.	Baseline, one month, three months

Collaborators and Investigators

• Sponsor: Zhi-fen Feng

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): December 25, 2022

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HUSOM2021-289

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