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

This study has been completed.
Complexo Hospitalario Universitario de Vigo
Universidad Autonoma de Madrid
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Carlos RodrÃ-guez Pascual, Hospital de Meixoeiro Identifier:
First received: February 25, 2010
Last updated: April 16, 2016
Last verified: June 2011

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.

Condition Intervention
Heart Failure
Other: Disease management program
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial

Resource links provided by NLM:

Further study details as provided by Hospital de Meixoeiro:

Primary Outcome Measures:
  • Mortality or readmission [ Time Frame: one year ]

Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: one year ]

Enrollment: 700
Study Start Date: October 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counselling
Educational intervention, monitoring of clinical status, monitoring of treatment adherence
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.
Active Comparator: Comparator
Usual care
Behavioral: Usual care
Usual care


Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT01076465

Hospital Meixoeiro
Vigo, Pontevedra, Spain, 36200
Sponsors and Collaborators
Hospital de Meixoeiro
Complexo Hospitalario Universitario de Vigo
Universidad Autonoma de Madrid
Fondo de Investigacion Sanitaria
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carlos RodrÃ-guez Pascual, MD, PhD, Hospital de Meixoeiro Identifier: NCT01076465     History of Changes
Other Study ID Numbers: PI081280
PI081280 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria, Spain )
Study First Received: February 25, 2010
Last Updated: April 16, 2016

Keywords provided by Hospital de Meixoeiro:
Heart failure
Disease management

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 25, 2017