Condition category
Circulatory System
Date applied
03/11/2004
Date assigned
01/02/2005
Last edited
23/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carlos Brotons

ORCID ID

Contact details

Sardenya Primary Care Center
Sardenya 466
Barcelona
08025
Spain
+34 93 56 74 380
cbrotons@eapsardenya.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

IC-DOM

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

The combination of cardiovascular mortality and rehospitalisations (emergency room and/or hospital) at one year.

Secondary outcome measures

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.

Overall trial start date

01/01/2004

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant 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

Recruitment start date

01/01/2004

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Spain

Trial participating centre

Sardenya Primary Care Center
Barcelona
08025
Spain

Sponsor information

Organisation

Sardenya Primary Care Center (Spain) - in collaboration with the Catalan Foundation Institute of Pharmacology

Sponsor details

Sardenya 466
Barcelona
08025
Spain
+34 93 56 74 380
cbrotons@eapsardenya.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Catalan Department of Health (Agencia d'Avaluacio de Tecnologia i Recerca Mèdiques) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Educational grants from:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

1. Pfizer (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

2. Almirall-Prodesfarma SA (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

3. Sanofi-Synthelabo (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

4. AstraZeneca (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

5. Novartis (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16194498
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19401125

Publication citations

  1. Protocol

    Brotons C, Martínez M, Rayó E, Morralla C, Ballarín E, Pérez E, , [Randomised clinical trial to evaluate the efficacy of a multi-factorial intervention to reduce hospitalisation and improve the quality of life of patients with heart failure]., Aten Primaria, 2005, 36, 5, 280-283.

  2. Results

    Brotons C, Falces C, Alegre J, Ballarín E, Casanovas J, Catà T, Martínez M, Moral I, Ortiz J, Pérez E, Rayó E, Recio J, Roig E, Vidal X, Randomized clinical trial of the effectiveness of a home-based intervention in patients with heart failure: the IC-DOM study., Rev Esp Cardiol, 2009, 62, 4, 400-408.

Additional files

Editorial Notes