Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure

August 3, 2023 updated by: Xiuxian Zhu, Zhongshan People's Hospital, Guangdong, China
This study aimed to evaluate the feasibility and effectiveness of a nurse-led multidisciplinary precision care in early cardiac rehabilitation of patients with chronic heart failure, and further to promote the application of nurse-led multidisciplinary precision care.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Enrolled patients were randomly divided as 1:1 ratio to experimental group and control group, while experimental group received nurse-led multidisciplinary precision care and the control group received standard care according to guidelines. The primary and secondary outcomes were evaluated and analyzed.

Study Type

Interventional

Enrollment (Estimated)

96

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
    • Guangdong
      • Zhongshan, Guangdong, China, 528400
        • Zhongshan City People's Hospital

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:

  • Aged from 18 to 80 years;
  • Conscious, with normal cognitive function and being communicable;
  • NYHA heart function class II-IV;
  • Patients met the diagnostic criteria of the clinical guidelines for the diagnosis and treatment of heart failure and were diagnosed with chronic heart failure;
  • Informed consent was obtained.

Exclusion Criteria:

  • Patients with congenital heart disease, cardiac shock, or persistent hypotension;
  • Patients with severe liver and kidney dysfunction, moderate to severe anemia or coagulation disorders, and other serious systemic complications;
  • Patients with a history of mental illness, a state of severe anxiety or depression, cognitive or communication impairments, and inability to communicate and respond to investigations;
  • Patients have been involved in other research that would interfere with this study;
  • Patients who declined cardiac rehabilitation and signed informed consent.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: multidisciplinary precision care group
Give the intervention of nurse-led multidisciplinary precision care
Other: multidisciplinary precision care
The experimental group received precision nursing based on a multidisciplinary collaborative team in addition to standard treatment and care
No Intervention: control group
standard care according to guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
left ventricular ejection fraction
Time Frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
baseline, pre-intervention, 1 month after intervention, 3 months after intervention
6-minute walking distance
Time Frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
baseline, pre-intervention, 1 month after intervention, 3 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life (QoL) questionnaires (QLQ) QLQ-C30 (version 3.0) score Quality of Life
Time Frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Symptom Check List-90
Time Frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Performance Status Score
Time Frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Numbers of patients with cardiovascular complications
Time Frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
baseline, pre-intervention, 1 month after intervention, 3 months after intervention

Collaborators and Investigators

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

Sponsor

Zhongshan People's Hospital, Guangdong, China

Investigators

  • Study Chair: Xiuxian Zhu, Zhongshan People's Hospital, Guangdong, China

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)

November 24, 2021

Primary Completion (Actual)

April 10, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2019-017

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

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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