Hospital-Community-Family-Care Management Platform for Chronic Heart Failure
HCF-CMP-CHF
Remote Prevention and Treatment Based on Community Under the Guidance of Regional Central Hospital for Patients With Chronic Heart Failure
1 other identifier
interventional
1,000
1 country
1
Brief Summary
The purpose of this study is to determine whether the Hospital-Community-Family-Care Management Platform for Chronic Heart Failure reduces the mortality, readmission rates and costs of the subjects with CHF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 21, 2013
CompletedFirst Posted
Study publicly available on registry
January 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 26, 2019
July 1, 2019
6.7 years
December 21, 2013
July 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all cause mortality
Number of subjects with all cause death
one year
Secondary Outcomes (1)
Heart failure morbidity
one year
Other Outcomes (8)
heart failure worsening
one year
Hospitalization rate
one year
Average hospitalization time
one year
- +5 more other outcomes
Study Arms (2)
Subjects with CHF follow-up
EXPERIMENTALSubjects with Hospital-Community-Family-Care Management Platform online and those with the clinic follow up.In the program, participants were educated on the use of smart health-tracking devices and mobile application (APP) to collect and upload comprehensive data elements related to the risk of CHF self-care management. They were also instructed to send text messages, view notifications, and receive individualized guidance on the mobile APP. The general practitioners viewed index of each participant on mobile APP and provided primary care periodically, and cardiologists in regional central hospital offered remote guidance and management if necessary. Outcomes assessed included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of heart failure-related health behaviors.
Subjects with CHF conventional clinic visit
ACTIVE COMPARATORSubjects with standardized treatment according to latest guidelines via conventional visit.
Interventions
Hospital-Community-Family-Care Management Platform Online: the remote monitoring service platform on line based on community and family for subjects with CHF under the guidance of the regional central hospital
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Eligibility Criteria
You may qualify if:
- Male and female are aged 18 years old or over.
- History of CHF for ≥3 months with NYHA functional class I-IV, of which class IV without strict bed rest.
- Left ventricular ejection fraction (LVEF) ≤45% as assessed by echocardiogram. However, LVEF can be above 45% for patients with cardiac insufficiency caused by atrial fibrillation, valvular heart disease, hypertrophic cardiomyopathy and et al;
- Treatment of CHF with stable and optimal pharmacological therapy according to Chinese guidelines for treatment of CHF. In general, optimal treatment will include a beta-blocker and an ACE inhibitor and/or an angiotensin receptor blocker, unless not tolerated. Medical therapy is defined as stable, if the subject has not started a new CHF drug class and the dose of drugs taken have not been changed during the 3 months prior to screening and randomization.
- Ability to understand the requirements of the study and willingness to provide written informed consent (IC), and agreement to abide by the study restrictions and return for the required assessments.
- Subjects are located in our coverage of the remote monitoring system.
You may not qualify if:
- Some secondary cardiomyopathy: hyperthyroid heart disease and anemic heart disease, and et al;
- A history of malignancy, and life expectancy is less than 1 year；
- Severe primary hepatic and renal insufficiency (alanine aminotransferase≥100 u/L, serum creatinine \>3.0mg/dL, serum albumin \<2.5g/L);
- Refusal to participate;
- Unable to visit outpatient clinics periodically;
- Ambulatory population;
- Patients were considered inappropriate to participate by researchers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiang Gulead
- Science and Technology Department of Jiangsu Provincecollaborator
- Yangzhou Municipal Health Bureaucollaborator
Study Sites (1)
Department of cardiovascular medicine,Northern Jiangsu Hospital
Yangzhou, Jiangsu, 225001, China
Study Officials
- PRINCIPAL INVESTIGATOR
Xiang Gu, Docter
Department of cardiovascular medicine
- PRINCIPAL INVESTIGATOR
Jianhua Shen, Docter
Department of cardiovascular medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Cardiology, Director of Cardiovascular Medicine
Study Record Dates
First Submitted
December 21, 2013
First Posted
January 7, 2014
Study Start
December 1, 2013
Primary Completion
August 1, 2020
Study Completion
December 1, 2020
Last Updated
July 26, 2019
Record last verified: 2019-07