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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00505050
First received: July 18, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted

July 18, 2007
July 18, 2007
October 1999
Not Provided
The prespecified primary end-points were (1) combined death secondary to any cause or unplanned first hospitalization and (2) quality of life changes.
Same as current
No Changes Posted
(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.
Same as current
Not Provided
Not Provided
 
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
Not Provided

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Heart Failure
Other: Disease Program Management

This DMP inclused intervention content with education for out patients and caregivers; medication management with optimized therapy based on guidelines, and remote monitoring; delivery personnel with nurses, cardiologists, pharmacists, social workers, dietitians, physical therapists, psychologists; face-to-face individual/group communication, and telephone in-person; the intensity/complexity was long-term follow-up with 6 months interval repetitive education; the environment was hospital out-patient; and the outcomes measured were clinical, quality of life, and adherence.

After randomization patients undergone our multidisciplinary education sessions 60-minute long that covered the basic principles related to heart failure. Telephone calls were used to reinforce the contents of the sessions of the ambulatory education activity, and monitoring of the compliance/adherence, symptoms/signs of worsening heart failure, and self-control mechanisms.

No Intervention: 1
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.
Intervention: Other: Disease Program Management

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
September 2006
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00505050
829/99
No
Not Provided
University of Sao Paulo
Not Provided
Principal Investigator: Edimar Bocchi Heart Institute of São University Medical School
University of Sao Paulo
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP