Efficacy of a Disease Management Program in Very Old Patients With Heart Failure
|ClinicalTrials.gov Identifier: NCT01076465|
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : April 19, 2016
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:
- patient education to improve disease' knowledge and self-care
- monitoring of clinical status
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Comorbidity Case-manager||Other: Disease management program Behavioral: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Lifestyle counselling
Educational intervention, monitoring of clinical status, monitoring of treatment adherence
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.
Active Comparator: Comparator
Behavioral: Usual care
- Mortality or readmission [ Time Frame: one year ]
- Health related quality of life [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076465
|Vigo, Pontevedra, Spain, 36200|