Post-discharge Monitoring of Patients With Heart Failure (CARDIOENF)
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CARDIOENF
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CONTROL
INTERVENTION
Arm Description
Outcomes
Primary Outcome Measures
hospital readmission
admission to the emergency department or hospitalization
Secondary Outcome Measures
signs and symptoms of decompensation of heart failure
Full Information
NCT ID
NCT03512782
First Posted
April 19, 2018
Last Updated
September 4, 2018
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Irmandade Santa Casa de Misericórdia de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03512782
Brief Title
Post-discharge Monitoring of Patients With Heart Failure
Acronym
CARDIOENF
Official Title
Effectiveness of the Monitoring of Signs and Symptoms After Discharge From Hospital of Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
March 30, 2019 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Irmandade Santa Casa de Misericórdia de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CONTROL
Arm Type
No Intervention
Arm Title
INTERVENTION
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
CARDIOENF
Intervention Description
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.
Primary Outcome Measure Information:
Title
hospital readmission
Description
admission to the emergency department or hospitalization
Time Frame
1 month
Secondary Outcome Measure Information:
Title
signs and symptoms of decompensation of heart failure
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emiliane Souza, PhD
Phone
555133038858
Email
enogsouza@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emiliane Souza, PhD
Email
emilianes@ufcspa.edu.br
Facility Information:
Facility Name
Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMILIANE N DE SOUZA, RN, PhD
Phone
555133038858
Email
emilianes@ufcspa.edu.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-discharge Monitoring of Patients With Heart Failure
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