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

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ClinicalTrials.gov Identifier: NCT01076465
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : April 19, 2016
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

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:

  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 or disease Intervention/treatment
Heart Failure Comorbidity Case-manager Other: Disease management program Behavioral: Usual care

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2009
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlos RodrÃ-guez Pascual, MD, PhD, Hospital de Meixoeiro
ClinicalTrials.gov Identifier: NCT01076465     History of Changes
Other Study ID Numbers: PI081280
PI081280 ( Other Grant/Funding Number: Fondo de Investigación Sanitaria, Spain )
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: June 2011

Keywords provided by Carlos RodrÃ-guez Pascual, Hospital de Meixoeiro:
Heart failure
Disease management

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases