Post-discharge Monitoring of Patients With Heart Failure

Not Applicable

• Conditions: Heart Failure
• Interventions: Other: CARDIOENF

• Registration Number: NCT03512782
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Brief Summary

What is proposed in this project is to develop and evaluate the effectiveness of an online remote monitoring system that is easily accessible to patients so that professionals with experience in monitoring patients with heart failure (HF) can monitor signs and symptoms of decompensation of the disease, as well as self-care actions. A randomized, blind trial for outcome evaluation was designed that will include patients hospitalized for acute HF at a referral institution in cardiology in southern Brazil. Patients in the intervention group will be followed up with a remote monitoring system, accessible by device (computer, tablet and cell phone) connected to the internet, by checking for signs, symptoms and self-care actions in three moments during 30 days after hospital discharge. Patients in the control group will follow up according to the routine of the hospital or physician assistant. The primary endpoint for assessing the efficacy of the system will be hospital readmission within 30 days (follow-up period). The information regarding the signs, symptoms and self-care of the patients will be monitored by the research team through an access schedule. The sample calculation points to the need to include a total of 142 patients (71 in each group). The data will be analyzed through descriptive and analytical statistics. It is hoped that the development of a remote monitoring system could be characterized as a strategy for the early detection of signs and symptoms of acute decompensation in HF patients, impacting on hospital readmission rates within 30 days after discharge. In addition, remote monitoring of signs and symptoms may promote improved adherence and self-care of patients. The scientific contribution will occur to the extent to which there is innovation in patient follow-up and feedback obtained from the patient's interaction with the system.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-05-01
• Status Verified: 2018-09
• Study Start: 2018-09-01
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05
• Primary Completion: 2019-03-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• with diagnosis of HF or hospitalized for acute HF

Exclusion Criteria

• degenerative neurological diseases;
• patients with renal / hepatic / pulmonary or systemic disease that may confuse the interpretation of findings or result in limited life expectancy;
• surgical or therapeutic plan that may influence the follow-up;
• pregnancy;
• diagnosis of acute HF secondary to: sepsis, myocarditis, acute myocardial infarction, peripartum and other acute cause;
• not be able to contact by phone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTERVENTION	CARDIOENF	-

Primary Outcome Measures

Name	Time	Method
hospital readmission	1 month	admission to the emergency department or hospitalization

Secondary Outcome Measures

Name	Time	Method
signs and symptoms of decompensation of heart failure	1 month

Trial Locations

Locations (1)

Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil