Clinical trial NCT01076465: Efficacy of a Disease Management Program in Very Old Patients With Heart Failure
Official title: Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Comorbidity
Case-manager
Keywords: Heart failure
Elderly
Disease management
Lead sponsor: Hospital de Meixoeiro
Sponsor class: OTHER_GOV
Collaborators: name: Complejo Hospitalario Universitario de Vigo
name: Universidad Autonoma de Madrid
name: Fondo de Investigacion Sanitaria
First posted: 2010-02-26
Enrollment: 700
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality or readmission
timeFrame: one year
Secondary outcomes:
measure: Health related quality of life
timeFrame: one year
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Meixoeiro
state: Pontevedra
Study officials:
References:
citation: Pascual CR, Galan EP, Guerrero JL, Colino RM, Soler PA, Calvo MH, Jaurieta JJ, Arambarri JM, Casado JM, Rodriguez-Artalejo F. Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics). BMC Public Health. 2011 Aug 5;11:627. doi: 10.1186/1471-2458-11-627.