Heart Failure Clinical Trial
Official title:
Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial
The purpose of this study is to assess the efficacy of a disease management programme (DMP)
for very old patients with HF and significant co-morbidity.
METHODS: A multicenter randomized trial will be conducted with 700 patients with heart
failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments
in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care.
Randomization will be stratified by hospital and performed with concealment of the
allocation list.
The DMP will be conducted by a case manager, and will include three main components:
1. patient education to improve disease' knowledge and self-care
2. monitoring of clinical status
3. therapeutic adherence. Main statistical analyses will be performed according to the
intention-to-treat principle, and will use Cox regression models to examine the
association of a DMP with hospital readmission, quality-of-life, and mortality over 12
months.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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