Effectiveness of patient self-managed structured education for type 2 diabetes (The Diabetes Manual): a cluster randomised-controlled trial

ISRCTN	ISRCTN06315411
DOI	https://doi.org/10.1186/ISRCTN06315411
Protocol serial number	N/A
Sponsor	University of Warwick (UK) - Centre for Primary Health Care Studies
Funder	Diabetes UK (UK)

Submission date: 04/11/2005
Registration date: 20/01/2006
Last edited: 17/08/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jackie Sturt
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effectiveness of patient self-managed structured education for type 2 diabetes (The Diabetes Manual): a cluster randomised-controlled trial
Study acronym	The Diabetes Manual Programme
Study objectives	Engagement with the Diabetes Manual will reduce HbA1c and cardiovascular disease (CVD) risk factors, improve self-efficacy and quality of life.
Ethics approval(s)	Ethics approval received from the Northern and Yorkshire Multi-centre Research Ethics Committee (MREC) on the 8th June 2004.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/05/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	424
Key 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
Key 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
Date of first enrolment	08/06/2004
Date of final enrolment	31/05/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

NHS R&D Lecturer in Social Sciences

Coventry
CV4 7AL
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2008		Yes	No
Protocol article	protocol	17/07/2006		Yes	No

Editorial Notes

17/08/2018: Publication reference added