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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• type 2 diabetes

• able to understand and answer a Danish questionnaire

Locations
Other Locations
Denmark
Steno Diabetes Center Aarhus
RECRUITING
Aarhus
Contact Information
Primary
Anette Andersen, MD, PhD
anette.andersen@rm.dk
+4522135605
Backup
Katrine B Bonnén, MSc in Public Health
KATBON@rm.dk
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2028-02
Participants
Target number of participants: 2000
Treatments
Experimental: Type 2 diabetes patients_intervention
Patients with type 2 diabetes in general practices randomised to the intervention group will answer a diabetes-specific PRO questionnaire (PRODIAP) in the annual consultations
No_intervention: Type 2 diabetes patients_control
Patients in general practices randomised to the control group
Sponsors
Collaborators: Steno Diabetes Center Odense, Steno Diabetes Center Sjaelland, Aarhus University Hospital
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov