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

Clinical Epidemiology Unit
Hospital Donostia
Dr Beguirisain 107-115
San Sebastian
20014
Spain

Phone +34 943 00 71 47
Email joseignacio.emparanza@osakidetza.net

Study information

Study designRandomised controlled open clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation of a strategy to diminish admissions in patients with heart failure: a randomised controlled open clinical trial
Study acronymTele-EMAI
Study objectivesPatients 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) studiedHeart failure
InterventionControl 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 typeOther
Primary outcome measureMeasured at the end of the study (see above anticipated end date):
1. Number of admissions
2. Number of emergency department visits
Secondary outcome measuresMeasured 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 date20/02/2008
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants70 patients
Key inclusion criteria1. 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 criteria1. Moderate or severe dementia
2. Physical disability for aerobic activities
3. Refusal to participate
Date of first enrolment20/02/2008
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Spain

Study participating centre

Clinical Epidemiology Unit
San Sebastian
20014
Spain

Sponsor information

Hospital Donostia (Spain)
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
Email joseignacio.emparanza@osakidetza.net
Website http://www.hospitaldonostia.org/index2.htm
ROR logo "ROR" 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan