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

Sponsor
Zhongshan People's Hospital, Guangdong, China (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05987267
Collaborator
(none)
96
Enrollment
1
Location
2
Arms
37.2
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: multidisciplinary precision care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure
Actual Study Start Date :
Nov 24, 2021
Actual Primary Completion Date :
Apr 10, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. left ventricular ejection fraction [baseline, pre-intervention, 1 month after intervention, 3 months after intervention]

  2. 6-minute walking distance [baseline, pre-intervention, 1 month after intervention, 3 months after intervention]

Secondary Outcome Measures

  1. 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 [baseline, pre-intervention, 1 month after intervention, 3 months after intervention]

  2. Symptom Check List-90 [baseline, pre-intervention, 1 month after intervention, 3 months after intervention]

  3. Performance Status Score [baseline, pre-intervention, 1 month after intervention, 3 months after intervention]

  4. Numbers of patients with cardiovascular complications [baseline, pre-intervention, 1 month after intervention, 3 months after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan City People's Hospital Zhongshan Guangdong China 528400

Sponsors and Collaborators

  • Zhongshan People's Hospital, Guangdong, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiuxian Zhu, Principal Investigator, Zhongshan People's Hospital, Guangdong, China
ClinicalTrials.gov Identifier:
NCT05987267
Other Study ID Numbers:
  • K2019-017
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Aug 14, 2023