Contact information
Type
Scientific
Primary contact
Prof Jeremy Dale
ORCID ID
Contact details
Warwick Medical School
Medical School Building
Gibbet Hill campus
University of Warwick
Coventry
CV4 7AL
United Kingdom
+44 (0) 2476 522891
Jeremy.Dale@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Telecare
Study hypothesis
To enhance the well-being of patients living with type 2 diabetes through the provision of expert telecare (nurse or peer consultation by phone) following treatment change.
Ethics approval
The study has been granted ethical approval by the Warwickshire LREC Committee on 15.03.04 (ref.no.610)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Type 2 diabetes
Intervention
Participants are randomly assigned to one of the three arms of the trial:
1. Telephone support provided by a diabetes specialist nurse
2. Telephone support provided by a peer supporter (i.e. also living with diabetes)
3. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Self-efficacy scores
Secondary outcome measures
Clinical outcomes (HbA1c, cholesterol level, blood pressure, Body Mass Index [BMI])
Overall trial start date
01/10/2004
Overall trial end date
01/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients with type 2 diabetes, for whom the most recent HbA1c is greater than 7.4%
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
300
Participant exclusion criteria
1. Patients receiving insulin therapy
2. Patients lacking a telephone
3. Those with severe accompanying disorders or judged by General Practitioner as likely to interfere with outcome interpretation
Recruitment start date
01/10/2004
Recruitment end date
01/11/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Warwick Medical School
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
The BUPA Foundation (UK)
Sponsor details
BUPA House
15-19 Bloomsbury Way
London
WC1A 2BA
United Kingdom
+44 (0) 20 76562591
saunderl@bupa.com
Sponsor type
Charity
Website
Funders
Funder type
Government
Funder name
The BUPA Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department of Health Ad Hoc Funding (UK)
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
Study protocol on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17598895
Publication citations
-
Study protocol
Dale J, Caramlau I, Docherty A, Sturt J, Hearnshaw H, Telecare motivational interviewing for diabetes patient education and support: a randomised controlled trial based in primary care comparing nurse and peer supporter delivery., Trials, 2007, 8, 18, doi: 10.1186/1745-6215-8-18.