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

NCT ID: NCT00505050

Last Updated: 2007-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2006-09-30

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

Disease Program Management

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Principal Investigators

Edimar Bocchi

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São University Medical School

Locations

Heart Institute of São Paulo University Medical School

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Ayub-Ferreira SM, Mangini S, Issa VS, Cruz FD, Bacal F, Guimaraes GV, Chizzola PR, Conceicao-Souza GE, Marcondes-Braga FG, Bocchi EA. Mode of death on Chagas heart disease: comparison with other etiologies. a subanalysis of the REMADHE prospective trial. PLoS Negl Trop Dis. 2013 Apr 25;7(4):e2176. doi: 10.1371/journal.pntd.0002176. Print 2013.

Reference Type: DERIVED

PMID: 23638197 (View on PubMed)

Cruz Fd, Issa VS, Ayub-Ferreira SM, Chizzola PR, Souza GE, Moreira LF, Lanz-Luces JR, Bocchi EA. Effect of a sequential education and monitoring programme on quality-of-life components in heart failure. Eur J Heart Fail. 2010 Sep;12(9):1009-15. doi: 10.1093/eurjhf/hfq130. Epub 2010 Jul 29.

Reference Type: DERIVED

PMID: 20670963 (View on PubMed)

Issa VS, Amaral AF, Cruz FD, Ayub-Ferreira SM, Guimaraes GV, Chizzola PR, Souza GE, Bocchi EA. Glycemia and prognosis of patients with chronic heart failure--subanalysis of the Long-term Prospective Randomized Controlled Study Using Repetitive Education at Six-Month Intervals and Monitoring for Adherence in Heart Failure Outpatients (REMADHE) trial. Am Heart J. 2010 Jan;159(1):90-7. doi: 10.1016/j.ahj.2009.10.027.

Reference Type: DERIVED

PMID: 20102872 (View on PubMed)

Issa VS, Amaral AF, Cruz FD, Ferreira SM, Guimaraes GV, Chizzola PR, Souza GE, Bacal F, Bocchi EA. Beta-blocker therapy and mortality of patients with Chagas cardiomyopathy: a subanalysis of the REMADHE prospective trial. Circ Heart Fail. 2010 Jan;3(1):82-8. doi: 10.1161/CIRCHEARTFAILURE.109.882035. Epub 2009 Nov 20.

Reference Type: DERIVED

PMID: 19933408 (View on PubMed)

Other Identifiers

829/99

Identifier Type: -

Identifier Source: org_study_id