Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/07/2006
Date assigned
05/10/2006
Last edited
18/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bupafoundation.com

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

  1. 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.

Additional files

Editorial Notes