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
Secondary identifying numbers	N/A

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
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	Self-efficacy scores
Secondary outcome measures	Clinical outcomes (HbA1c, cholesterol level, blood pressure, Body Mass Index [BMI])
Overall study start date	01/10/2004
Completion date	01/11/2006

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	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

The BUPA Foundation (UK)
Charity

BUPA House
15-19 Bloomsbury Way
London
WC1A 2BA
United Kingdom

Government

The BUPA Foundation (UK)

No information available

Department of Health Ad Hoc Funding (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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

17/08/2018: Publication reference added