Post-discharge Monitoring of Patients With Heart Failure

NCT03512782 | Unknown

• 1 other identifier: 5085_15
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• hospital readmission

  admission to the emergency department or hospitalization

  1 month

Secondary Outcomes (1)

• signs and symptoms of decompensation of heart failure

  1 month

Study Arms (2)

CONTROL

NO INTERVENTION

INTERVENTION

EXPERIMENTAL

Other: CARDIOENF

Interventions

CARDIOENF OTHER

The patients listed in interventional group will have access to software Cardioenf that is a app used in a device (cel phone, tablet) to monitoring signs and symptoms of the heart failure patients after discharge from hospital. In this software, their signs and symptoms will be inserted in three moments during the first 30 days after discharge. Nurses will monitor these data in the follow-up period.

INTERVENTION

Eligibility Criteria

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

You may qualify if:

• with diagnosis of HF or hospitalized for acute HF

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Emiliane Souza, PhD

CONTACT

555133038858; enogsouza@gmail.com

Emiliane Souza, PhD

CONTACT

emilianes@ufcspa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: September 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: April 30, 2019
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)