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

This study is currently recruiting participants.
Verified June 2011 by Hospital de Meixoeiro
Sponsor:
Collaborators:
Funadación Biomedica del Complejo Hospitalario Universitario de Vigo
Universidad Autonoma de Madrid
Fondo de Investigacion Sanitaria
Information provided by:
Hospital de Meixoeiro
ClinicalTrials.gov Identifier:
NCT01076465
First received: February 25, 2010
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

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 HF, 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
Comorbidity
Case-manager
 Other: Disease management program
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Hospital de Meixoeiro:

Primary Outcome Measures:
  • Mortality or readmission [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: October 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (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

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076465

Contacts
Contact: Carlos Rodriguez-Pascual, MD 34-986-811111 carlos.rodriguez.pascual@sergas.es

Locations
Spain
Hospital Meixoeiro Recruiting
Vigo, Pontevedra, Spain, 36200
Contact: carlos Rodriguez-Pascual, MD     34-986-811111     carlos.rodriguez.pascual@sergas.es    
Principal Investigator: Carlos Rodriguez-Pascual, MD            
Sub-Investigator: Arturo Vilches-Moraga, PhD            
Sub-Investigator: Ana Isabel Ferrero Martinez            
Sub-Investigator: Emilio Paredes_Galan, PhD            
Sponsors and Collaborators
Hospital de Meixoeiro
Funadación Biomedica del Complejo Hospitalario Universitario de Vigo
Universidad Autonoma de Madrid
Fondo de Investigacion Sanitaria
  More Information

No publications provided by Hospital de Meixoeiro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Carlos Rodriguez Pascual, MD, Hospital Meixoeiro
ClinicalTrials.gov Identifier: NCT01076465     History of Changes
Other Study ID Numbers: PI081280, PI081280
Study First Received: February 25, 2010
Last Updated: June 15, 2011
Health Authority: Spain: Ethics Committee
Spain: Ministry of Health
Spain: Instituto de Salud Carlos III

Keywords provided by Hospital de Meixoeiro:
Heart failure
Elderly
Disease management

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013