House, A orcid.org/0000-0001-8721-8026, Bryant, L orcid.org/0000-0002-1972-7395, Russell, A orcid.org/0000-0002-8891-9059 et al. (10 more authors) (2018) Randomized controlled feasibility trial of supported self-management in adults with Type 2 diabetes mellitus and an intellectual disability: OK Diabetes. Diabetic Medicine, 35 (6). pp. 776-788. ISSN 0742-3071
Abstract
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2018 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Cardiovascular and Metabolic Medicine (LICAMM) |
Funding Information: | Funder Grant number NIHR National Inst Health Research 10/102/03 |
Depositing User: | Symplectic Publications |
Date Deposited: | 10 Jul 2018 13:38 |
Last Modified: | 10 Jul 2018 13:40 |
Status: | Published |
Publisher: | Wiley |
Identification Number: | 10.1111/dme.13626 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:133122 |