A Long-Term Prospective Randomized Controlled Study Using Repetitive Education at Six-Month Intervals and Monitoring for Adherence in Heart Failure Outpatients - The REMADHE Study

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Other: Disease Program Management

• Registration Number: NCT00505050
• Lead Sponsor: University of Sao Paulo

Brief Summary

Recent meta-analysis reported reduction in mortality and hospitalization of HF patients.However, important issues in DMP for HF remain to be resolved. DMP are not homogeneous concerning methodology and in general included only elderly patients; most were tested in high-risk HF patients discharged from hospital; quality of life results are controversial; few reports included long-term results; some protocols had limited enrollment of screened patients, and it was suggested that could be less effective when patients are already followed by HF specialist.Improved survival was associated with cardiologist care as well with multidisciplinary teams providing specialized follow-up.Whether both together could benefits HF is not well defined. Also, no studies reported the long-term effects of a cyclic repetitive reeducation program.We tested whether a DMP that consisted of a long-term repetitive education program associated with a telephone monitoring could benefit HF outpatients in usual ambulatory care already under care of cardiologist with experience in HF

Detailed Description

Not available

Study Timeline

• Study Start: 1999-10
• Study Completion: 2006-09
• Status Verified: 2007-07
• Study First Submitted: 2007-07-18
• Study First Submitted QC: 2007-07-18
• Last Update Submitted: 2007-07-18
• Study First Posted: 2007-07-20
• Last Update Posted: 2007-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Eligible patients on ambulatory care were aged 18 years or older with irreversible chronic heart .failure with at least 6 months duration, and non planned surgical procedure or other procedure that could influence the follow-up in the next 6 months

Exclusion Criteria

• impossibility for attendance of education sessions and monitoring based on non corrected limitations of transport, or unfavorable distance, or social, or of communication; myocardial infarction or unstable angina within 6 months before randomization; cardiac surgery or angioplasty within 6 months randomization; hospitalized patients or recent discharged patients; severe renal/hepatic/neurological/pulmonary or any systemic disease that could confuse the interpretation of results and impair expected survival; and pregnant women or women of childbearing potential.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Disease Program Management	Standard follow-up medical visits and treatment for control group were performed during the study period by the same cardiologist team that was not informed of the randomization.

Primary Outcome Measures

Name	Time	Method
The prespecified primary end-points were (1) combined death secondary to any cause or unplanned first hospitalization and (2) quality of life changes.

Secondary Outcome Measures

Name	Time	Method
(1) DMP feasibility;(2) death;(3)number and duration of hospitalization; (4) unexpected death in home and death during hospitalization; (5)emergency care necessity,(5) adherence.

Trial Locations

Locations (1)

Heart Institute of São Paulo University Medical School; 🇧🇷 Sao Paulo, SP, Brazil