Contact information
Type
Scientific
Primary contact
Dr Jose I Emparanza
ORCID ID
Contact details
Clinical Epidemiology Unit
Hospital Donostia
Dr Beguirisain 107-115
San Sebastian
20014
Spain
+34 943 00 71 47
joseignacio.emparanza@osakidetza.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EBM-012008
Study information
Scientific title
Evaluation of a strategy to diminish admissions in patients with heart failure: a randomised controlled open clinical trial
Acronym
Tele-EMAI
Study hypothesis
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
Local Medical Ethics Board (CEIC Gipuzkoa) approved on the 23rd January 2008 (ref: Acta 01/08)
Study design
Randomised controlled open clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
20/02/2008
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
70 patients
Participant exclusion criteria
1. Moderate or severe dementia
2. Physical disability for aerobic activities
3. Refusal to participate
Recruitment start date
20/02/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Spain
Trial participating centre
Clinical Epidemiology Unit
San Sebastian
20014
Spain
Sponsor information
Organisation
Hospital Donostia (Spain)
Sponsor details
c/o Jose I Emparanza
Clinical Epidemiology Unit
Dr. Beguiristain 107-115
San Sebastian
20014
Spain
+34 943 00 71 47
joseignacio.emparanza@osakidetza.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital Donostia (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Saludnova S.Coop (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
Basic results (scientific)
Publication list