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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01076465
First received: February 25, 2010
Last updated: April 16, 2016
Last verified: June 2011

February 25, 2010
April 16, 2016
October 2009
November 2013   (final data collection date for primary outcome measure)
Mortality or readmission [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01076465 on ClinicalTrials.gov Archive Site
Health related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of a Disease Management Program in Very Old Patients With Heart Failure
Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Heart Failure
  • Comorbidity
  • Case-manager
  • 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
  • Experimental: Lifestyle counselling
    Educational intervention, monitoring of clinical status, monitoring of treatment adherence
    Intervention: Other: Disease management program
  • Active Comparator: Comparator
    Usual care
    Intervention: Behavioral: Usual care
Pascual CR, Galán EP, Guerrero JL, Colino RM, Soler PA, Calvo MH, Jaurieta JJ, Arambarri JM, Casado JM, Rodríguez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
75 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01076465
PI081280, PI081280
No
Not Provided
Not Provided
Carlos RodrÃ-guez Pascual, Hospital de Meixoeiro
Hospital de Meixoeiro
  • Complexo Hospitalario Universitario de Vigo
  • Universidad Autonoma de Madrid
  • Fondo de Investigacion Sanitaria
Not Provided
Hospital de Meixoeiro
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP