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 |
| Secondary identifying numbers | N/A |
- 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
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
| 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 | 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 | 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 study start date | 08/06/2004 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
NHS R&D Lecturer in Social Sciences
Coventry
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
University of Warwick (UK) - Centre for Primary Health Care Studies
University/education
University/education
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
England
United Kingdom
| Website | http://www.warwick.ac.uk |
|---|---|
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Charity
Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/07/2006 | Yes | No | |
| Results article | results | 01/06/2008 | Yes | No |
Editorial Notes
17/08/2018: Publication reference added
