Abstract
OBJECTIVE: To pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale randomised controlled trial (RCT) to evaluate whether such a trial is feasible. DESIGN: Two-arm pilot RCT. PARTICIPANTS: Adults aged ≥18-39 years, with minimum 1 year type 1 diabetes duration, attending outpatient follow-up. Exclusion criteria were pregnancy, severe cognitive, somatic or psychiatric conditions and impaired vision. RANDOMISATION AND INTERVENTION: All participants completed electronic Patient-Reported Outcome Measures (PROMs) prior to the annual diabetes consultation. Using computer-generated block-randomisation without blinding, we assigned participants in a 1:1 ratio stratified by sex to receive standard care or an intervention. Physicians reviewed diabetes distress scores (Problem Areas In Diabetes scale) and referred individuals with scores ≥30 or single item(s) ≥3 to minimum two diabetes nurse consultations where reported problems were reviewed and discussed. OUTCOMES: Recruitment and retention rates; participants perceptions about intervention components. Variance and estimated between-group differences in follow-up scores (Diabetes Distress Scale (DDS), WHO 5-Well-being Index, Perceived Competence for Diabetes Scale and glycaemic control) and DDS correlation with baseline scores, to assist sample size calculations. RESULTS: We randomised 80 participants to the control or intervention arm (one participant was later excluded). 23/39 intervention arm participants qualified for additional consultations and 17 attended. 67/79 attended the 12-month follow-up (15.2% attrition); 5/17 referred to additional consultations were lost to follow-up (29.4% attrition). Participants reported PROMs as relevant (84.6%) and acceptable (97.4%) but rated the usefulness of consultations as moderate to low. Baseline mean±SD DDS score was 2.1±0.69; DDS SD was 0.71 (95% CI: 0.60 to 0.86) at follow-up; correlation between baseline and follow-up DDS scores was 0.8 (95% CI: 0.7 to 0.9). CONCLUSIONS: The pilot trial revealed need for intervention modifications ahead of a full-scale trial to evaluate use of PROMs in diabetes consultations. Specifically, participant acceptability and intervention implementation need further investigation.