Case-manager, Comorbidity, Heart Failure
Conditions
Keywords
Heart failure, Elderly, Disease management
Brief 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.
Interventions
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.
BEHAVIORALUsual care
Usual care
Sponsors
Complejo Hospitalario Universitario de Vigo
Universidad Autonoma de Madrid
Fondo de Investigacion Sanitaria
Hospital de Meixoeiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age:75 y or older 2. 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 3. 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
1. Participation refusal 2. Terminal illness 3. 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 4. Clinical instability as assessed with the Kosecof index 5. Being in waiting list for organ transplant or cardiac surgery 6. Inability to be followed-up because of other reasons (change of place of residence,..) 7. Institutionalization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality or readmission | one year |
Secondary
| Measure | Time frame |
|---|---|
| Health related quality of life | one year |
Countries
Spain
Outcome results
None listed