Telecare motivational interviewing for diabetes patient education and support: a randomised controlled trial based in primary care comparing nurse and peer supporter delivery

ISRCTN	ISRCTN63151946
DOI	https://doi.org/10.1186/ISRCTN63151946
Protocol serial number	N/A
Sponsor	The BUPA Foundation (UK)
Funders	The BUPA Foundation (UK), Department of Health Ad Hoc Funding (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jeremy Dale
Scientific

Warwick Medical School
Medical School Building
Gibbet Hill campus
University of Warwick
Coventry
CV4 7AL
United Kingdom

Phone	+44 (0) 2476 522891
Email	Jeremy.Dale@warwick.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Telecare motivational interviewing for diabetes patient education and support: a randomised controlled trial based in primary care comparing nurse and peer supporter delivery
Study acronym	Telecare
Study objectives	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(s)	The study has been granted ethical approval by the Warwickshire LREC Committee on 15.03.04 (ref.no.610)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Self-efficacy scores
Key secondary outcome measure(s)	Clinical outcomes (HbA1c, cholesterol level, blood pressure, Body Mass Index [BMI])
Completion date	01/11/2006

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	300
Key inclusion criteria	Adult patients with type 2 diabetes, for whom the most recent HbA1c is greater than 7.4%
Key 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
Date of first enrolment	01/10/2004
Date of final enrolment	01/11/2006

Warwick Medical School

Coventry
CV4 7AL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2009		Yes	No
Protocol article	protocol	28/06/2007		Yes	No

17/08/2018: Publication reference added