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Effects of the PRoactive Interdisciplinary Self-MAnagement (PRISMA) program on self-reported and clinical outcomes in type 2 diabetes: a pragmatic randomized controlled trial |
du Pon E, Kleefstra N, Cleveringa F, van Dooren A, Heerdink ER, van Dulmen S |
BMC Endocrine Disorders 2019 Dec 11;19(139):Epub |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Diabetes self-management education can be helpful for patients with type 2 diabetes in managing their condition. We aimed to study the effects of the group-based PRoactive Interdisciplinary Self-MAnagement (PRISMA) training program on self-reported and clinical outcomes in patients with type 2 diabetes treated in general practice. METHODS: Persons aged 18 years or older diagnosed with type 2 diabetes and treated in primary care were included. In a randomized controlled trial design (1:1), patients were followed for 6 months with an extension phase of 6 months. Block randomization was used. The patients with type 2 diabetes received either PRISMA in addition to usual care or usual care only. All patients completed a range of validated questionnaires (including knowledge, skills, and confidence for self-management (PAM), diabetes self-care behavior (SDSCA), health-related quality of life (EQ-5D), and emotional well-being (WHO-5)). In addition, clinical outcomes (HbA1c, body mass index, systolic blood pressure, and cholesterol levels) were collected during the routine diabetes checkups. RESULTS: Of the total sample (n = 193), 60.1% were men. The mean age was 69.9 years (SD 9.1). No significant differences were found on self-reported outcomes between the groups at 0, 6, and 12 months. The clinical outcomes were not reported due to a large number of missing values. CONCLUSION: PRISMA did not improve self-reported outcomes in patients with type 2 diabetes treated in primary care. It was not possible to make a statement about the clinical effects. TRIAL REGISTRATION: Date 16/07/2014, number NL4550 (https://www.trialregister.nl/trial/4550).
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