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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure, Comorbidity, Case-manager

Intervention / Treatment
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* Other: Disease management program
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:75 y or older Co-morbidity or dependency. At least one of the following criteria: Charlson index >3, dependency in 2 or more basic activities of daily living,treatment with 5 or more drugs, urgent hospitalization in the last 3 months, three or more diseases with active treatment, limitation in daily living because of vision or hearing impairment, cognition deficit, Parkinson disease, diabetes mellitus, chronic obstructive lung disease, severe anemia, constitutional syndrome Hospital admission with a main diagnosis of heart failure (according to the criteria of the European Society of Cardiology or Framingham criteria) in NYHA functional class II-IV. Exclusion Criteria: Participation refusal Terminal illness Cognitive decline or severe cognitive deficit, which does not permit a minimum knowledge of the disease, or lack of carers which give consent to study participation Clinical instability as assessed with the Kosecof index Being in waiting list for organ transplant or cardiac surgery Inability to be followed-up because of other reasons (change of place of residence,..) Institutionalization

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counselling<br>Educational intervention, monitoring of clinical status, monitoring of treatment adherence | Other: Disease management program<br>* 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.<br>|
| Active Comparator: Comparator<br>Usual care | Behavioral: Usual care<br>* Usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality or readmission |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Elderly, Disease management