The effect of a primary care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: a cluster-randomized controlled trial
Abstract
Background Little is known about how best to intervene against diabetes distress in patients recently diagnosed with type 2 diabetes mellitus. We evaluate the effect of a structured, inter-sectoral primary care intervention on diabetes distress in individuals during the 12 months following diagnosis. Method In a cluster-randomized controlled trial, 30 general practice clinics in the Region of Southern Denmark were randomized 1:1 to an intervention or routine diabetes care. The intervention was designed to improve continuity of care, quality of care, and patient diabetes literacy. Patients completed the 17-item Diabetes Distress Scale (DDS-17) shortly after diagnosis and again 12 months later. The primary outcome was between-group changes in DDS scores over time. Secondary outcomes included between-group changes in HbA1c and HDL cholesterol levels between diagnosis and follow-up. Results A total of 193 patients completed the baseline questionnaire (58 control; 136 intervention), 87 also completed 12-month follow-up (23 control, 64 intervention). The initial DDS indicated that 28.4% of the entire sample experienced distress. This increased to 32.1% at follow-up. No significant group differences were found in changes of overall DDS scores (β = − 0.25, 95% CI = − 0.49, 0.00). A statistically significant effect was observed on interpersonal diabetes distress, with a group x time interaction (β = − 0.30, 95% CI = − 0.54, − 0.06). Reductions in the number of patients with abnormal…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 193 participants or records.
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