Condition category
Circulatory System
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
19/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 Optivolâ„¢ 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

Contact information

Type

Scientific

Primary contact

Ms Lisa Fletcher

ORCID ID

Contact details

Southampton General Hospital
E Level Research Office
Tremona Road
Southampton
SO16 6YD
United Kingdom

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 measures

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

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

http://www.soton.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

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.