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

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN06315411
• Lead Sponsor: niversity of Warwick (UK) - Centre for Primary Health Care Studies

Brief Summary

1. 2006 protocol in https://www.ncbi.nlm.nih.gov/pubmed/16846517 2. 2008 results in https://www.ncbi.nlm.nih.gov/pubmed/18435777

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-20
• Study Completion: 2006-05-31
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 424

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c. <br><br>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

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