Developing care pathways for remote monitoring
| ISRCTN | ISRCTN47114929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47114929 |
| Secondary identifying numbers | 6877 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 19/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
More heart failure patients now receive device-based treatment in the form of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation defibrillators (CRT-D), but despite this, admissions and healthcare costs relating to heart failure continue to rise. Recent device technology that transmits data from an implanted cardiac pacing device to a monitoring station in the home can predict left ventricular heart failure deterioration. The aim of this study was to evaluate the relative costs and the acceptability of conventional and remote care pathways designed to monitor implanted device technology for chronic disease in the home.
Who can participate?
Heart failure patients over 16 years old with implanted ICD/CRT-D devices.
What does the study involve?
The remote monitoring group (consisting of patients with implanted Medtronic devices with the Optivol™ intrathoracic impedance feature) were compared with control patients implanted with devices that did not have access to remote monitoring and who followed the usual standard pathway of care. The remote monitoring group were further randomly allocated into two groups, either remotely downloading daily for three months and then weekly for three months, or downloading weekly for the six-month period. The downloads were reviewed on the day of download by the study nurse, who reported to the consultant responsible and made medication or programming changes where required.
What are the possible benefits and risks of participating?
There are no disadvantages or risks as the care will be the same whether the volunteer chooses to participate or not. It is hoped that the results may help us develop better ways of preventing hospital admissions for heart pump failure and heart rhythm abnormalities in the future.
Where is the study run from?
Southampton General Hospital (UK).
When is the study starting and how long is it expected to run for?
The study ran from February 2009 to August 2009.
Who is funding the study?
Medtronic Ltd (UK).
Who is the main contact?
Ms Lisa Fletcher
lisa.fletcher@suht.swest.nhs.uk
Contact information
Scientific
Southampton General Hospital
E Level Research Office
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Randomised interventional process of care trial with qualitative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A pilot study developing care pathways for remote monitoring |
| Study objectives | The aim of this study is to determine and document a projects viability to allow development of a future larger prospective randomised control trial to determine morbidity, cost efficacy and mortality of remote disease management for heart failure and arrhythmia burden. |
| Ethics approval(s) | Berkshire Research Ethics Committee, 20/10/2008, ref: 08/H0505/131 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | 6 month study of two groups. Group 1: Observation so diary entry and Quality of life questionnaires only. Group 2 (interventional): Study group download from device using Carelink. Divided into A and B: Group A: daily downloads for three months and then weekly for remainding three months Group B: weekly download for the whole duration - six months Based on the information obtained from the downloads will determine if treatment needed to be changed - i.e., medication or programme changes to device. Follow up length: 0 months Study entry: Other |
| Intervention type | Other |
| Primary outcome measure | Quality of Life is measured uisng the Living with Heart failure Minnesota Life Score and 36-item short form health survey (SF-36) at baseline, 1, 3 and 6 months |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/02/2009 |
| Completion date | 31/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Key inclusion criteria | All participants: 1. Be on stable medical therapy for 6 weeks prior to recruitment 2. Have the ability to independently comprehend and complete QOL Questionnaires 3. Have an episode of New York Heart Association (NHYA) class III heart failure 4. Be on optimal medical therapy 5. Male and female, lower age limit of 16 years Group 2 additional criteria: 6. Must be implanted with a Medtronic Device that has the optivol feature 7. Have had a cardiac device implanted for at least 3 months prior to recruitment 8. Will have had no device related complications |
| Key exclusion criteria | 1. If unable to use the technology due to mental or physical limitations 2. Less than 16 years old 3. Pregnancy |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 31/08/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton
SO16 6YD
United Kingdom
Sponsor information
University/education
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Website | http://www.soton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | There are no plans to publish this study. |
| IPD sharing plan |
Editorial Notes
19/09/2016: Verified study status with principal investigator.
13/09/2016: No publications found in PubMed, verifying study status with principal investigator.
