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 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/11/2004
- Registration date
- 01/02/2005
- Last edited
- 23/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Carlos Brotons
Scientific
Scientific
Sardenya Primary Care Center
Sardenya 466
Barcelona
08025
Spain
| Phone | +34 93 56 74 380 |
|---|---|
| cbrotons@eapsardenya.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2004 |
| Overall study end date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Participant 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. |
| 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
Study participating centre
Sardenya Primary Care Center
Barcelona
08025
Spain
08025
Spain
Sponsor information
Sardenya Primary Care Center (Spain) - in collaboration with the Catalan Foundation Institute of Pharmacology
Hospital/treatment centre
Hospital/treatment centre
Sardenya 466
Barcelona
08025
Spain
| Phone | +34 93 56 74 380 |
|---|---|
| cbrotons@eapsardenya.net |
Funders
Funder type
Government
Catalan Department of Health (Agencia d'Avaluacio de Tecnologia i Recerca Mèdiques) (Spain)
No information available
Educational grants from:
No information available
1. Pfizer (Spain)
No information available
2. Almirall-Prodesfarma SA (Spain)
No information available
3. Sanofi-Synthelabo (Spain)
No information available
4. AstraZeneca (Spain)
No information available
5. Novartis (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/09/2005 | Yes | No | |
| Results article | results | 01/04/2009 | Yes | No |
