Evaluation of a strategy to diminish admissions in patients with heart failure
ISRCTN | ISRCTN62033748 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN62033748 |
Secondary identifying numbers | EBM-012008 |
- Submission date
- 21/09/2009
- Registration date
- 06/10/2009
- Last edited
- 06/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose I Emparanza
Scientific
Scientific
Clinical Epidemiology Unit
Hospital Donostia
Dr Beguirisain 107-115
San Sebastian
20014
Spain
Phone | +34 943 00 71 47 |
---|---|
joseignacio.emparanza@osakidetza.net |
Study information
Study design | Randomised controlled open clinical trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Evaluation of a strategy to diminish admissions in patients with heart failure: a randomised controlled open clinical trial |
Study acronym | Tele-EMAI |
Study objectives | Patients with heart failure may benefit from at home telemonitorisation of their condition plus multifaceted personalised intervention compared with multifaceted personalised intervention alone. |
Ethics approval(s) | Local Medical Ethics Board (CEIC Gipuzkoa) approved on the 23rd January 2008 (ref: Acta 01/08) |
Health condition(s) or problem(s) studied | Heart failure |
Intervention | Control group: Automated program for opportunity/appropriateness of drug treatment with a personalised and monitored physical activity (aerobic) program. Follow-up telephone calls will take place on day 3 and 6, and every 15 days thereafter by the appointed nurse, and a telephone line and email address will be accessible 24 hours a day. Intervention group: As above, plus at home measurement twice daily of transdermal oxygen saturation, temperature, weight, blood pressure, cardiac and respiratory frequency, and in some cases, electrocardiogram (ECG). These measurements are sent by GSM to the hospital team. |
Intervention type | Other |
Primary outcome measure | Measured at the end of the study (see above anticipated end date): 1. Number of admissions 2. Number of emergency department visits |
Secondary outcome measures | Measured at the end of the study (see above anticipated end date): 1. Quality of life (36-item short form health survey [SF-36]) at the beginning and end of the study 2. Perceived quality of medical attention, measured using the Spanish SERVQHOS questionnaire, at the beginning and end of the study |
Overall study start date | 20/02/2008 |
Completion date | 31/12/2009 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Senior |
Sex | Both |
Target number of participants | 70 patients |
Key inclusion criteria | 1. Patients of any gender, aged older than 65 years 2. Heart failure stage III - IV New York Heart Association (NYHA) 3. At least two admissions during the previous year |
Key exclusion criteria | 1. Moderate or severe dementia 2. Physical disability for aerobic activities 3. Refusal to participate |
Date of first enrolment | 20/02/2008 |
Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
Clinical Epidemiology Unit
San Sebastian
20014
Spain
20014
Spain
Sponsor information
Hospital Donostia (Spain)
Hospital/treatment centre
Hospital/treatment centre
c/o Jose I Emparanza
Clinical Epidemiology Unit
Dr. Beguiristain 107-115
San Sebastian
20014
Spain
Phone | +34 943 00 71 47 |
---|---|
joseignacio.emparanza@osakidetza.net | |
Website | http://www.hospitaldonostia.org/index2.htm |
https://ror.org/04fkwzm96 |
Funders
Funder type
Hospital/treatment centre
Hospital Donostia (Spain)
No information available
Saludnova S.Coop (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 |