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

ISRCTN	ISRCTN35096435
DOI	https://doi.org/10.1186/ISRCTN35096435
Protocol serial number	N/A
Sponsor	Sardenya Primary Care Center (Spain) - in collaboration with the Catalan Foundation Institute of Pharmacology
Funders	Catalan Department of Health (Agencia d'Avaluacio de Tecnologia i Recerca Mèdiques) (Spain), Educational grants from:, 1. Pfizer (Spain), 2. Almirall-Prodesfarma SA (Spain), 3. Sanofi-Synthelabo (Spain), 4. AstraZeneca (Spain), 5. Novartis (Spain)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Carlos Brotons
Scientific

Sardenya Primary Care Center
Sardenya 466
Barcelona
08025
Spain

Phone	+34 93 56 74 380
Email	cbrotons@eapsardenya.net

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	IC-DOM
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Heart Failure
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	The combination of cardiovascular mortality and rehospitalisations (emergency room and/or hospital) at one year.
Key secondary outcome measure(s)	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.
Completion date	30/09/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key inclusion criteria	400 patients recruited from four hospitals in Catalonia: Vall dHebron 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.
Key exclusion criteria	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
Date of first enrolment	01/01/2004
Date of final enrolment	30/09/2006

Sardenya Primary Care Center

Barcelona
08025
Spain

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2009		Yes	No
Protocol article	protocol	30/09/2005		Yes	No