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

Hospital de Meixoeiro

Status: Completed

Conditions: Heart Failure; Case-manager; Comorbidity

Treatments: Other: Disease management program; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01076465

PI081280 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 700 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Lifestyle counselling

Experimental group

Description:

Educational intervention, monitoring of clinical status, monitoring of treatment adherence

Treatment:

Other: Disease management program

Comparator

Active Comparator group

Description:

Usual care

Treatment:

Behavioral: Usual care