Condition category
Circulatory System
Date applied
14/01/2010
Date assigned
09/02/2010
Last edited
27/06/2012
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

Prof Paul Dendale

ORCID ID

Contact details

Jessa Hospital
Stadsomvaart 11
Hasselt
3500
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Telemonitoring in heart failure: a multicentre randomised trial

Acronym

Study hypothesis

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

Medical Ethical Committee of Jessa Hospital approved on the 29th November 2007 (ref: 07.70/cardio07.13)

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

Blood B-type natriuretic peptide (BNP) content, measured at entry of study, and after 6 months of follow-up.

Overall trial start date

01/04/2008

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant 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

Recruitment start date

01/04/2008

Recruitment end date

01/06/2010

Locations

Countries of recruitment

Belgium

Trial participating centre

Jessa Hospital
Hasselt
3500
Belgium

Sponsor information

Organisation

Heart Centre Hasselt vzw (Belgium)

Sponsor details

Begeveldstraat
Bilzen
3740
Belgium

Sponsor type

Hospital/treatment centre

Website

http://www.jessazh.be/

Funders

Funder type

Research organisation

Funder name

Heart Centre Hasselt vzw (Belgium)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22045925

Publication citations

  1. Results

    Dendale P, De Keulenaer G, Troisfontaines P, Weytjens C, Mullens W, Elegeert I, Ector B, Houbrechts M, Willekens K, Hansen D, Effect of a telemonitoring-facilitated collaboration between general practitioner and heart failure clinic on mortality and rehospitalization rates in severe heart failure: the TEMA-HF 1 (TElemonitoring in the MAnagement of Heart Failure) study., Eur. J. Heart Fail., 2012, 14, 3, 333-340, doi: 10.1093/eurjhf/hfr144.

Additional files

Editorial Notes