Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of patient self-managed structured education for type 2 diabetes (The Diabetes Manual): a cluster randomised-controlled trial
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2006 protocol in https://www.ncbi.nlm.nih.gov/pubmed/16846517
2. 2008 results in https://www.ncbi.nlm.nih.gov/pubmed/18435777
Publication citations
-
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.