Randomized controlled feasibility trial of supported self‐management in adults with Type 2 diabetes mellitus and an intellectual disability: OK Diabetes

• Published in: Diabetic medicine Vol. 35; no. 6; pp. 776 - 788
• Main Authors: House, A., Bryant, L., Russell, A. M., Wright‐Hughes, A., Graham, L., Walwyn, R., Wright, J. M., Hulme, C., O'Dwyer, J. L, Latchford, G., Stansfield, A., Ajjan, R., Farrin, A.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.06.2018; John Wiley and Sons Inc
• Subjects: Affect; Blood Pressure - physiology; Body Mass Index; Clinical trials; Cognitive ability; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - nursing; Diabetes Mellitus, Type 2 - psychology; Evidence-based medicine; Feasibility Studies; Female; Glycated Hemoglobin - metabolism; House Calls - statistics & numerical data; Humans; Insulin; Intellectual disabilities; Intellectual Disability - complications; Intellectual Disability - nursing; Male; Management; Medication Adherence; Middle Aged; Obesity - complications; Obesity - nursing; Physical activity; Research: Educational and Psychological Aspects; Self-Management - methods; Social Support; Surveys and Questionnaires
• ISSN: 0742-3071; 1464-5491
• DOI: 10.1111/dme.13626

Aims To undertake a feasibility randomized controlled trial of supported self‐management vs treatment as usual in a population of adults with obesity, Type 2 diabetes and an intellectual disability. Methods We conducted an individually randomized feasibility trial. Participants were adults aged >18 years with a mild or moderate intellectual disability, living in the community with Type 2 diabetes, on any therapy other than insulin. Participants had mental capacity to consent to research and the intervention. Inclusion criteria included HbA1c > 48 mmol/mol (6.5%), BMI >25 kg/m2, or self‐reported physical activity below national guideline levels. The experimental intervention was standardized supported self‐management delivered by diabetes specialist nurses plus treatment as usual, compared with treatment as usual alone. Feasibility outcomes included: recruitment and retention; intervention acceptability and feasibility; data collection and completeness for physiological state and values for candidate primary outcomes (HbA1c and BMI). Results A total of 82 participants (89% of those contacted and eligible) were randomized. All supported self‐management sessions were completed by 35/41 participants (85%); only four completed no sessions. Data on the follow‐up candidate primary outcomes HbA1c and BMI were obtained for 75/82 (91%) and 77/82 participants (94%), respectively. The mean baseline HbA1c was 56±16.5 mmol/mol (7.3±1.5%) and the mean BMI was 34±7.6 kg/m2. Conclusions Adherence to supported self‐management and willingness to have blood taken for outcome measurement was good. A definitive randomized controlled trial is feasible in this population. (Trial registration: Current Controlled Trials ISRCTN41897033) What's new? This is the largest published randomized study of Type 2 diabetes mellitus self‐management in community‐living adults with an intellectual disability. Recruitment was 89% of contacted eligible respondents. Over 90% of randomized participants were retained in the study, with primary outcome data collected at follow‐up. Adherence to self‐management was good; 85% completed all sessions. HbA1c levels were in line with general population rates for Type 2 diabetes. Obesity and physical inactivity were a major problem. We have demonstrated the feasibility of conducting a definitive phase III trial in adults with an intellectual disability.