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

Hospital de Meixoeiro1 site in 1 country700 target enrollmentOctober 2009

ConditionsHeart Failure Comorbidity Case-manager

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Hospital de Meixoeiro
Enrollment: 700
Locations: 1
Primary Endpoint: Mortality or readmission
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

November 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital de Meixoeiro

Responsible Party

Principal Investigator

Carlos RodrÃ-guez Pascual

MD, PhD

Hospital de Meixoeiro

Eligibility Criteria

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