NCT01076465

Efficacy of a Disease Management Program in Very Old Patients With Heart Failure

Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: Hospital de Meixoeiro · Other Government
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Failure
• Comorbidity
• Case-manager

Interventions

Type	Name	Description
OTHER	Disease management program	1\. Educational intervention on management of heart failure and comorbidity to improve patient's knowledge of his/her disease and self-care 2) Monitoring of clinical status 3) Monitoring and improvement of therapeutic adherence.
BEHAVIORAL	Usual care	Usual care

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2010-02-26
• Last updated: 2016-04-19

Locations

1 site across 1 country: Spain