Clinical trial NCT05987267: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nurse's Role
Multidisciplinary Communication
Chronic Heart Failure
Lead sponsor: Zhongshan People's Hospital, Guangdong, China
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: left ventricular ejection fraction
timeFrame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
measure: 6-minute walking distance
timeFrame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Secondary outcomes:
measure: 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
timeFrame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
measure: Symptom Check List-90
timeFrame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
measure: Performance Status Score
timeFrame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
measure: Numbers of patients with cardiovascular complications
timeFrame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
Study officials:
affiliation: Zhongshan People's Hospital, Guangdong, China
name: Xiuxian Zhu
role: STUDY_CHAIR
References: