Clinical trial NCT02029287: Hospital-Community-Family-Care Management Platform for Chronic Heart Failure
Official title: Remote Prevention and Treatment Based on Community Under the Guidance of Regional Central Hospital for Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Chronic heart failure
telemedicine
health service platform
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
Collaborators: name: Science and Technology Department of Jiangsu Province
name: Yangzhou Municipal Health Bureau
First posted: 2014-01-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: (1) Indication: Chronic Heart Failure. (2) Objectives: Primary objective is to evaluate the efficacy of the Hospital-Community-Family-Care Management Platform online compared with the regular clinic follow up in subjects with CHF (I-IV class by NYHA, of which class IV without strict bed rest).Secondary objectives is to assess the safety of the Management Platform online in subjects with CHF. (3) Study design: Prospective, randomized, controlled study with two follow up management groups: 1) the Hospital-Community-Family-Care Management Follow up Online; 2) the regular monthly clinic follow up. Study population: Totally 1000 male and female subjects with CHF (I-IV functional class according to NYHA classification). (4) Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing. (5) Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. (6) Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources. (7) Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. (8) Duration of follow up: The total follow-up time shall be at least 12 months. (9) Safety Assessment: Safety of the study will be evaluated by the following assessments: 1) Subject and object examinations (during the follow up period and extending up to 2 week after the end of the study) consisting of a subject interview (including direct questioning about adverse events), physical examination, assessment of body weight, Electrocardiogram (ECG) and echocardiogram (UCG), Left ventricular ejection fraction (LVEF), assessed by echocardiography, The N-terminal prohormone of brain natriuretic peptide (NT-proBNP), a peptide hormone whose plasma concentration is inversely related to the severity of HF, NYHA functional status, assessed by subject interview, 6-minute walk distance (6MWD), Quality of life (QoL), assessed by the Minnesota Living with Heart Failure questionnaire (MLHFQ), a validated questionnaire assessing QoL in subjects with heart failure. 2) Evaluation of clinically relevant safety laboratory parameters, such as complete blood count, serum creatinine, electrolytes, and liver enzymes. Any Adverse Events (AE) or Serious Adverse Events (SAE) and its potential causal relationship with the study will be recorded and evaluated.

Eligibility criteria: Inclusion Criteria:Inclusion Criteria:to be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below at the time of screening and randomization:

1. Male and female are aged 18 years old or over.
2. History of CHF for ≥3 months with NYHA functional class I-IV, of which class IV without strict bed rest.
3. 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;
4. 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.
5. 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.
6. Subjects are located in our coverage of the remote monitoring system.

Exclusion Criteria:To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below at screening and randomization:

1. Some secondary cardiomyopathy: hyperthyroid heart disease and anemic heart disease, and et al;
2. A history of malignancy, and life expectancy is less than 1 year；
3. Severe primary hepatic and renal insufficiency (alanine aminotransferase≥100 u/L, serum creatinine \>3.0mg/dL, serum albumin \<2.5g/L);
4. Refusal to participate;
5. Unable to visit outpatient clinics periodically;
6. Ambulatory population;
7. Patients were considered inappropriate to participate by researchers.

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
measure: Heart failure morbidity
timeFrame: one year
Other outcomes:
measure: heart failure worsening
timeFrame: one year
measure: Hospitalization rate
timeFrame: one year
measure: Average hospitalization time
timeFrame: one year
measure: Costs of medications
timeFrame: one year
measure: Usability of the HCF intervention for patients
timeFrame: 4 months
measure: Changes of self-management
timeFrame: 4 months
measure: Engagement of the intervention
timeFrame: 4 months
measure: Participants perceptions of intervention components
timeFrame: 4 months
Locations:
city: Yangzhou
country: China
facility: Department of cardiovascular medicine,Northern Jiangsu Hospital
state: Jiangsu
Study officials:
affiliation: Department of cardiovascular medicine
name: Xiang Gu, Docter
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of cardiovascular medicine
name: Jianhua Shen, Docter
role: PRINCIPAL_INVESTIGATOR
References: