Back to resultsNurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure
Primary Purpose
Nurse's Role, Multidisciplinary Communication, Chronic Heart Failure
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multidisciplinary precision care
Sponsored by
About this trial
This is an interventional treatment trial for Nurse's Role
Eligibility Criteria
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.
Sites / Locations
- Zhongshan City People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
multidisciplinary precision care group
control group
Arm Description
Give the intervention of nurse-led multidisciplinary precision care
standard care according to guidelines
Outcomes
Primary Outcome Measures
left ventricular ejection fraction
6-minute walking distance
Secondary Outcome Measures
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
Symptom Check List-90
Performance Status Score
Numbers of patients with cardiovascular complications
Full Information
NCT ID
NCT05987267
First Posted
July 26, 2023
Last Updated
August 3, 2023
Sponsor
Zhongshan People's Hospital, Guangdong, China
1. Study Identification
Unique Protocol Identification Number
NCT05987267
Brief Title
Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure
Official Title
Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan People's Hospital, Guangdong, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nurse's Role, Multidisciplinary Communication, Chronic Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
multidisciplinary precision care group
Arm Type
Experimental
Arm Description
Give the intervention of nurse-led multidisciplinary precision care
Arm Title
control group
Arm Type
No Intervention
Arm Description
standard care according to guidelines
Intervention Type
Other
Intervention Name(s)
multidisciplinary precision care
Intervention Description
The experimental group received precision nursing based on a multidisciplinary collaborative team in addition to standard treatment and care
Primary Outcome Measure Information:
Title
left ventricular ejection fraction
Time Frame
baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Title
6-minute walking distance
Time Frame
baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Secondary Outcome Measure Information:
Title
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
Title
Symptom Check List-90
Time Frame
baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Title
Performance Status Score
Time Frame
baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Title
Numbers of patients with cardiovascular complications
Time Frame
baseline, pre-intervention, 1 month after intervention, 3 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuxian Zhu
Organizational Affiliation
Zhongshan People's Hospital, Guangdong, China
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan City People's Hospital
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528400
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure
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