Efficacy of a Disease Management Program in Very Old Patients With Heart Failure
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076465
|Vigo, Pontevedra, Spain, 36200|