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ISRCTN
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ISRCTN35096435
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ClinicalTrials.gov identifier
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Public title
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Randomised clinical trial to assess the efficacy of a multifactorial intervention in order to reduce hospitalisation and improve quality of life in patients with heart failure
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Scientific title
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Acronym
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IC-DOM
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Serial number at source
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N/A
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Study hypothesis
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To assess the efficacy of a multidisciplinary non-pharmacologic intervention to reduce mortality and rehospitalisation, and to improve quality of life in patients with heart failure.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Heart Failure
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Participants - inclusion criteria
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400 patients recruited from four hospitals in Catalonia: Vall d’Hebron Hospital, Clínic Hospital, Dos de Maig Hospital and Vic Hospital.
Inclusion Criteria:
Males and females without any limit of age, discharged from the hospital with the diagnosis of heart failure following the criteria of the European Society of Cardiology.
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Participants - exclusion criteria
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1. Patients with heart failure due to reversible causes (hyperthyroidism, tachyarrhythmia, valve disease candidate for surgery)
2. Patients with concomitant chronic disease (cancer, chronic renal failure etc.)
3. Patients with poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study
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Anticipated start date
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01/01/2004
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Anticipated end date
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30/09/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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A multidisciplinary approach to patient education and counselling, optimisation of the treatments (drugs, diet, exercise), monitorisation of the electrolyte concentrations if necessary, and teaching education on self monitoring and management. The number of scheduled home visits will be 12 (every month), with telephone calls every 15 days.
Control:
Patients in the control group will be assigned to conventional care receiving standard treatments.
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Primary outcome measure(s)
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The combination of cardiovascular mortality and rehospitalisations (emergency room and/or hospital) at one year.
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Secondary outcome measure(s)
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1. Total mortality or rehospitalisation for any reason
2. Rehospitalisation due to heart failure
3. Time until rehospitalisation
4. Days of hospitalisation
5. Quality of life related to health
Statistical models to be used will be survival analysis and Cox regression.
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Sources of funding
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1. Catalan Department of Health (Agencia d'Avaluacio de Tecnologia i Recerca Mèdiques) (Spain)
2. Educational grants from:
2.1. Pfizer (Spain)
2.2. Almirall-Prodesfarma SA (Spain)
2.3. Sanofi-Synthelabo (Spain)
2.4. AstraZeneca (Spain)
2.5. Novartis (Spain)
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Trial website
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Publications
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1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16194498
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19401125
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Contact name
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Dr
Carlos
Brotons
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Address
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Sardenya Primary Care Center
Sardenya 466
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City/town
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Barcelona
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Zip/Postcode
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08025
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Country
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Spain
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Tel
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+34 93 56 74 380
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Fax
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+34 93 56 74 381
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Email
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cbrotons@eapsardenya.net
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Sponsor
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Sardenya Primary Care Center (Spain) - in collaboration with the Catalan Foundation Institute of Pharmacology
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Address
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Sardenya 466
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City/town
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Barcelona
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Zip/Postcode
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08025
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Country
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Spain
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Tel
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+34 93 56 74 380
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Fax
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+34 93 56 74 381
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Email
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cbrotons@eapsardenya.net
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Date applied
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03/11/2004
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Last edited
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23/07/2009
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Date ISRCTN assigned
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01/02/2005
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