Extrait

Background and study aims The prevalence of diabetes, in particular type 2 diabetes, is increasing at an alarming rate. It is expected that the current obesity epidemic will result in the rapid growth of the number of patients with diabetes and subsequently result in greater treatment costs. Diabetes is associated with a number of health complications including blindness, heart disease, stroke, kidney problems, amputation, nerve damage, pregnancy complications and birth defects. This is a particular concern for Birmingham and the West Midlands as not only do the West Midlands have one of the highest levels of obesity in the country, but Birmingham also includes several population groups at high risk of diabetes and its complications. Despite the surge in research into the disease, there are still many gaps in our knowledge and understanding of type 2 diabetes. There is insufficient information about the following factors in diabetes and their impact on quality of life: stress levels, obstructive sleep apnoea, sleep duration and quality, physical activity levels, and diabetes-related distress and mental health. This study aims to understand the health status of patients with diabetes across one primary care trust serving a population of 300,000, one of the largest primary care trusts in the UK. The three phases of the study (PRIDE 1, PRIDE 2 and PRIDE 3) have specific aims. PRIDE 1 aims to approach a large number of patients with type 1 and type 2 diabetes across the South Birmingham Primary Care Trust (SBPCT). This phase aims to gather: 1. Demographic data including age, sex, ethnicity, level of education and social background 2. Lifestyle data including alcohol intake, smoking status, dietary intake and physical activity 3. Anthropometric data including height, weight, and neck and waist circumference 4. Healthcare utilization data 5. Co-morbidity data including retinopathy, nephropathy, neuropathy, cerebrovascular disease, ischaemic heart disease and peripheral arterial disease 6. Medications 7. Sleep data including daytime sleepiness, sleep quality 8. Quality of life 9. Mental health risks PRIDE 2 aims to approach a sub-population within the cohort with type 2 diabetes for further detailed study and assessment of: 1. Diabetic microvascular complications including diabetic neuropathy, diabetic nephropathy and diabetic retinopathy 2. Obstructive sleep apnoea 3. Sleep quality and duration 4. Diet and physical activity 5. Stress 6. Quality of life 7. Depression and anxiety 8. Coping styles 9. Perceived control of health 10. Readiness to change health behaviour 11. Impulsivity and cognitive function PRIDE 3 aims to recruit up to 40 patients for an in-depth interview to explore patients’ experiences living with type 2 diabetes. Interviews will be carried out at study entry, 12 and 24 months. Who can participate? Adults aged 18 or over who have registered with a GP practice within South Birmingham Primary Care Trust and have been diagnosed with diabetes. PRIDE 1 will include type 1 and type 2 diabetes patients. PRIDE 2 and 3 will only include type 2 diabetes patients. What does the study involve? PRIDE 1: Patients with type 1 and 2 diabetes across South Birmingham Primary Care Trust will be approached through primary care. Patients attending their local GP surgery for their annual diabetes visit will receive a recruitment pack from their diabetes specialist nurse containing: patient information sheet, consent form, first questionnaire booklet, current anthropometric measurements form (to be completed by the nurse), a contact details form, and a return envelope. Patients will be asked to return their completed questionnaire, consent form and biomedical results slip in the pre-paid business envelope provided if they would like to participate. Patients will also be asked to provide optional contact details if they would like to participate in future research. PRIDE 2: A sub-cohort of 1000 patients who took part in PRIDE 1 will be randomly selected and invited to PRIDE 2. They will receive a patient information leaflet, consent form and second questionnaire booklet. Patients who provide consent and are eligible will be invited to two measurement sessions with a team of researchers at a local community centre. Session 1 will include: blood sampling, urine sampling, blood pressure measurement, foot screening, height/weight and hip/waist measurements, administration of wrist-worn actigraphy device, administration of ApneaLink device, administration of sleep diary and instructions for saliva sampling. Session 2 will include: morning awakening cortisol via saliva sampling, dietary interview and readiness to change interview. PRIDE 3: Up to 40 eligible patients who consented in PRIDE 2 will be invited to undergo three home interviews over a 2-year period. Interviews will explore the following issues: patients’ current priorities in their lives; impact of unemployment; impact on self-esteem; perceived risk of diabetic complications; perspectives on sleep and understanding of available health services. What are the possible benefits and risks of participating? PRIDE will identify patient-specific factors which contribute to diabetes and could aid patient care and wellbeing. The study will address important gaps in our understanding of diabetes on health and will aid development of more tailored and effective interventions to improve health outcomes in patients with diabetes. Only the blood sample poses a minor risk. Where is the study run from? South Birmingham Primary Care Trust (UK). When is the study starting and how long is it expected to run for? The study started in May 2012 and will run for 2 years. Who is funding the study? National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care (NIHR - CLAHRC) (UK). Who is the main contact? Mrs Sopna Choudhury [email protected]

Critère d'inclusion

• Diabetes, Sleep disorders

Liens

• isrctn
• ictrp