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dc.contributor.authorHernar, Ingvild
dc.contributor.authorGraue, Marit
dc.contributor.authorRichards, David A
dc.contributor.authorStrandberg, Ragnhild Bjarkøy
dc.contributor.authorNilsen, Roy Miodini
dc.contributor.authorRekdal, Magne
dc.contributor.authorLøvaas, Karianne Fjeld
dc.contributor.authorMadsen, Tone Vonheim
dc.contributor.authorTell, Grethe Seppola
dc.contributor.authorHaugstvedt, Anne
dc.description.abstractObjective: 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.en_US
dc.publisherBMJ Publishing Groupen_US
dc.rightsNavngivelse-Ikkekommersiell 4.0 Internasjonal*
dc.subjectDiabetes støtte til egenmestringen_US
dc.subjectDiabetes self-mangement supporten_US
dc.titleUse of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trialen_US
dc.typeJournal articleen_US
dc.typePeer revieweden_US
dc.rights.holderCopyright Author(s) (or their employer(s)) 2021.en_US
dc.source.journalBMJ Openen_US
dc.subject.nsiVDP::Endokrinologi: 774en_US
dc.subject.nsiVDP::Endocrinology: 774en_US
dc.subject.nsiVDP::Endokrinologi: 774en_US
dc.subject.nsiVDP::Endocrinology: 774en_US
dc.identifier.citationBMJ Open. 2021, 11, e042353.en_US

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Navngivelse-Ikkekommersiell 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse-Ikkekommersiell 4.0 Internasjonal