Diabetes 6 (D-6) trial: psychologically enhanced diabetes care, delivered by nurses
Phase 2
Completed
- Conditions
- Topic: Diabetes Research NetworkSubtopic: Type 2Disease: Hypertension, Dyslipidaemia, Diabetic Control, Obesity, Prevention/screeningNutritional, Metabolic, EndocrineDiabetes
- Registration Number
- ISRCTN75776892
- Lead Sponsor
- King's College Hospital NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 432
Inclusion Criteria
1. People with Type 2 diabetes for more than 2 years
2. Resident in south London boroughs of Lambeth Southwark and Lewisham
3. Aged 18 - 79 years, either sex
4. Persistent suboptimal glycaemic control defined as HbA1c above or equal to 8% on occasions in the past 12 months despite 2 appointments with a diabetes health professional
Exclusion Criteria
1. Severe mental disorders
2. Terminal illnesses and severe end stage diabetes complications
3. Morbid obesity with a body mass index (BMI) greater than 50 kg/m^2 as there is usually comorbid psychiatric morbidity
4. No telephone or mobile phone access as telephone contact is part of the intervention
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycaemic control) at 18 months
- Secondary Outcome Measures
Name Time Method 1. Total cholesterol, taken at baseline and at end of study<br>2. Blood pressure, taken at baseline and at end of study<br>3. BMI, taken at baseline and at end of study<br>4. Quality of life, measured before and after intervention<br>5. Depressive symptoms, measured before and after intervention<br>6. Economic evaluation, measured before and after intervention