Condition category
Circulatory System
Date applied
21/09/2009
Date assigned
06/10/2009
Last edited
06/10/2009
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 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 measures

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

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

http://www.hospitaldonostia.org/index2.htm

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes