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

January 15, 2025 updated by: Zhi-fen Feng

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-efficacy management indicators
Time Frame: Baseline, one month, three months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-care indicators
Time Frame: Baseline, one month, three months
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
Time Frame: Baseline, one month, three months
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
Time Frame: Baseline, one month, three months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Re-hospitalisation indicators
Time Frame: Baseline, one month, three months
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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