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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05987267
Other study ID # K2019-017
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 24, 2021
Est. completion date December 31, 2024

Study information

Verified date August 2023
Source Zhongshan People's Hospital, Guangdong, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 96
Est. completion date December 31, 2024
Est. primary completion date April 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Other:
multidisciplinary precision care
The experimental group received precision nursing based on a multidisciplinary collaborative team in addition to standard treatment and care

Locations

Country Name City State
China Zhongshan City People's Hospital Zhongshan Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary left ventricular ejection fraction baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Primary 6-minute walking distance baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Secondary 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
Secondary Symptom Check List-90 baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Secondary Performance Status Score baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Secondary Numbers of patients with cardiovascular complications baseline, pre-intervention, 1 month after intervention, 3 months after intervention
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