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

NCT05987267 | Unknown

• 1 other identifier: K2019-017
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurse's Role; Multidisciplinary Communication; Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• left ventricular ejection fraction

  baseline, pre-intervention, 1 month after intervention, 3 months after intervention

• 6-minute walking distance

  baseline, pre-intervention, 1 month after intervention, 3 months after intervention

Secondary Outcomes (4)

• 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

• Symptom Check List-90

  baseline, pre-intervention, 1 month after intervention, 3 months after intervention

• Performance Status Score

  baseline, pre-intervention, 1 month after intervention, 3 months after intervention

• Numbers of patients with cardiovascular complications

  baseline, pre-intervention, 1 month after intervention, 3 months after intervention

Study Arms (2)

multidisciplinary precision care group

EXPERIMENTAL

Give the intervention of nurse-led multidisciplinary precision care

Other: multidisciplinary precision care

control group

NO INTERVENTION

standard care according to guidelines

Interventions

multidisciplinary precision care OTHER

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

multidisciplinary precision care group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan People's Hospital, Guangdong, China: lead

Study Sites (1)

Zhongshan City People's Hospital

Zhongshan, Guangdong, 528400, China

Location

Study Officials

• Xiuxian Zhu

  Zhongshan People's Hospital, Guangdong, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: November 24, 2021
• Primary Completion: April 10, 2023
• Study Completion: December 31, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)