Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/11/2005
Date assigned
20/01/2006
Last edited
20/11/2007
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

Dr Jackie Sturt

ORCID ID

Contact details

NHS R&D Lecturer in Social Sciences
Centre for Primary Health Care Studies
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The Diabetes Manual Programme

Study hypothesis

Engagement with the Diabetes Manual will reduce HbA1c and cardiovascular disease (CVD) risk factors, improve self-efficacy and quality of life.

Ethics approval

Ethics approval received from the Northern and Yorkshire Multi-centre Research Ethics Committee (MREC) on the 8th June 2004.

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

The Diabetes Manual Programme is administered to participants in the intervention group and compared to patients in the delayed intervention group who receive the intervention six months later.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

HbA1c.

Follow up for all measures is at six months post randomisation for both arms and 12 months post randomisation for the intervention arm to assess maintenance of effect on all measures.

Secondary outcome measures

1. Cholesterol
2. High Density Lipoprotein (HDL) cholesterol
3. Blood Pressure (BP)
4. Height, weight and Body Mass Index (BMI) calculated
5. Psychological distress, measured using a self-completion patient postal questionnaire
6. Quality of life
7. Self-efficacy

Follow up for all measures is at six months post randomisation for both arms and 12 months post randomisation for the intervention arm to assess maintenance of effect on all measures.

Overall trial start date

08/06/2004

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Less than 18 years
2. Confirmed clinical diagnosis of type 2 diabetes
3. Last clinical HbA1c not less than 7.0%
4. Ability to use the materials

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

424

Participant exclusion criteria

1. People taking insulin
2. People with learning disabilities and dementia
3. People whose health care needs are met by others (e.g. carers/nurses)
4. Unable to attend the surgery

Recruitment start date

08/06/2004

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS R&D Lecturer in Social Sciences
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK) - Centre for Primary Health Care Studies

Sponsor details

Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

http://www.warwick.ac.uk

Funders

Funder type

Charity

Funder name

Diabetes UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16846517

Publication citations

  1. Protocol

    Sturt J, Hearnshaw H, Farmer A, Dale J, Eldridge S, The Diabetes Manual trial protocol - a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411]., BMC Fam Pract, 2006, 7, 45, doi: 10.1186/1471-2296-7-45.

Additional files

Editorial Notes