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

NCT01076465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2016-04-19

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Disease management program

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.

BEHAVIORAL

Usual care

Usual care

Sponsors & Collaborators

  • Complejo Hospitalario Universitario de Vigo

    collaborator OTHER

  • Universidad Autonoma de Madrid

    collaborator OTHER

  • Fondo de Investigacion Sanitaria

    collaborator OTHER

  • Hospital de Meixoeiro

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01076465 on ClinicalTrials.gov