Evaluation of a strategy to diminish admissions in patients with heart failure

ISRCTN	ISRCTN62033748
DOI	https://doi.org/10.1186/ISRCTN62033748
Protocol serial number	EBM-012008
Sponsor	Hospital Donostia (Spain)
Funders	Hospital Donostia (Spain), Saludnova S.Coop (Spain)

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

Primary study design	Interventional
Study design	Randomised controlled open clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Measured at the end of the study (see above anticipated end date): 1. Number of admissions 2. Number of emergency department visits
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	70
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes