Telemonitoring in heart failure

ISRCTN	ISRCTN39223875
DOI	https://doi.org/10.1186/ISRCTN39223875
Protocol serial number	N/A
Sponsor	Heart Centre Hasselt vzw (Belgium)
Funder	Heart Centre Hasselt vzw (Belgium)

Submission date: 14/01/2010
Registration date: 09/02/2010
Last edited: 27/06/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Dendale
Scientific

Jessa Hospital
Stadsomvaart 11
Hasselt
3500
Belgium

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Telemonitoring in heart failure: a multicentre randomised trial
Study objectives	A heart failure clinic using telemonitoring of weight, blood pressure, heart rate and an automatic symptoms questionnaire allows to reduce the hospitalisation frequency, its duration and mortality. It also increases quality of life and reduces the number of unplanned consultations with the first and second line.
Ethics approval(s)	Medical Ethical Committee of Jessa Hospital approved on the 29th November 2007 (ref: 07.70/cardio07.13)
Health condition(s) or problem(s) studied	Congestive heart failure
Intervention	Telemonitoring will consist of daily patient self-measurements of body weight, blood pressure and heart rate with devices that allow automatic transfer of registered data to a web-site. This web-site will trigger E-mail alerts to care providers if data are out of limits, or if data have not been received. The tele-monitoring approach will be assisted by a central call centre, allowed to contact patients if technical problems with devices are suspected. The patients will also be called by an automatic telephone system to answer a short symptom questionnaire once every week. The total follow-up in control patients, and intervention for other patients, is 6 months.
Intervention type	Other
Primary outcome measure(s)	1. Number and duration of hospitalisation after the start of the study 2. Number of unplanned consultations with the heart failure team and GP 3. Number of phone calls (and amount of time spent) between the HF nurse and the patient 4. Quality of life (Minnesota Living with Heart Failure Questionnaire) 5. Mortality rate 6. Number of medication changes 7. Number of changes in alert limits Measured at entry of study, and after 6 months of follow-up.
Key secondary outcome measure(s)	Blood B-type natriuretic peptide (BNP) content, measured at entry of study, and after 6 months of follow-up.
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	160
Key inclusion criteria	1. Patients hospitalised for decompensated heart failure, necessitating intravenous (IV) diuretics or augmentation of oral (PO) diuretic, IV inotropic or IV vasodilator. Patients should be stabilised with treatment including angiotensin converting enzyme (ACE) inhibitors (or angiotensin II receptor antagonists [AIIA]), betablockers and diuretics at discharge. 2. Patients should be capable of understanding the aims of the study and to use the telemonitoring system 3. Aged between 50 and 85 years, either sex
Key exclusion criteria	1. Reversible forms of heart failure 2. Heart failure due to aortic stenosis 3. Isolated right heart failure 4. Patients residing in "elderly homes" 5. Severe renal disease (glomerular filtration rate [GFR] less than 20 ml/min), planned dialysis in the next 6 months 6. Planned implantation of biventricular pacemaker, or cardiac surgery 7. Life expectancy less than 1 year 8. Severe pulmonary disease
Date of first enrolment	01/04/2008
Date of final enrolment	01/06/2010

Locations

Countries of recruitment

Belgium

Study participating centre

Jessa Hospital

Hasselt
3500
Belgium

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?
Results article	results	01/03/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes