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 (REMADHE)
|ClinicalTrials.gov Identifier: NCT00505050|
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : July 20, 2007
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Other: Disease Program Management||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 1999|
|Actual Study Completion Date :||September 2006|
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.
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.
- The prespecified primary end-points were (1) combined death secondary to any cause or unplanned first hospitalization and (2) quality of life changes.
- (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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505050
|Heart Institute of São Paulo University Medical School|
|Sao Paulo, SP, Brazil, 05403-000|
|Principal Investigator:||Edimar Bocchi||Heart Institute of São University Medical School|