Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6877
Study information
Scientific title
A pilot study developing care pathways for remote monitoring
Acronym
Study hypothesis
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
Berkshire Research Ethics Committee, 20/10/2008, ref: 08/H0505/131
Study design
Randomised interventional process of care trial with qualitative study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/02/2009
Overall trial end date
31/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Participant exclusion criteria
1. If unable to use the technology due to mental or physical limitations
2. Less than 16 years old
3. Pregnancy
Recruitment start date
01/02/2009
Recruitment end date
31/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Medtronic Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
There are no plans to publish this study.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list