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PRODIAP - Patient-reported Outcomes in General Practice Among People With Type 2 Diabetes

Study acronym: PRODIAP
StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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In Denmark, around 327,000 diabetes consultations take place annually in general practice, but these often fail to fully include patients' experiences, values, and needs. Research, mainly among people with type 1 diabetes, suggests that the use of Patient Reported Outcomes (PROs) can enhance patient engagement and consultation quality. Yet, little is known about the effect of using PROs in type 2 diabetes (T2D) care in general practice. This project, PRODIAP (Patient-reported outcomes in general practice among people with type 2 diabetes) aims to investigate whether the use of a diabetes-specific PRO questionnaire can improve care quality and support more individualised consultations for people with T2D. PRODIAP is tailored to general practice, adapted from hospital PRO tools, and pilot testing showed promising feasibility and acceptability. This project applies a mixed-methods design with two sub-studies: 1. A pragmatic, cluster-randomised controlled trial in 30 general practices (N≈2000 patients) evaluating PRODIAP's effect on perceived care quality with patient perceived quality of care (PACIC) as primary outcome. 2. A qualitative study using observations and interviews to explore how PRODIAP shapes the consultation from both patient and professional perspectives. The project group has established a national collaboration with general practitioners, researchers and stakeholders from all five Danish region, supporting the feasibility of this study. Findings are expected to improve diabetes care in general practice and inform management of other chronic conditions. Findings are expected to improve diabetes care in general practice and provide transferable knowledge for other chronic conditions.
Trial Details
NCT Number NCT07767331
Lead Sponsor University of Aarhus
Collaborators: Steno Diabetes Center Odense, Steno Diabetes Center Sjaelland, Aarhus University Hospital
Conditions
(from sponsor)
Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov