Telemonitoring in heart failure
| ISRCTN | ISRCTN39223875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39223875 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Jessa Hospital
Stadsomvaart 11
Hasselt
3500
Belgium
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2008 |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
3500
Belgium
Sponsor information
Heart Centre Hasselt vzw (Belgium)
Hospital/treatment centre
Hospital/treatment centre
Begeveldstraat
Bilzen
3740
Belgium
| Website | http://www.jessazh.be/ |
|---|---|
"ROR" |
https://ror.org/03tw90478 |
Funders
Funder type
Research organisation
Heart Centre Hasselt vzw (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
