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RECRUITING
NCT07767331
NA

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

Sponsor: University of Aarhus

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-03-01

Completion Date

2028-02

Last Updated

2026-08-17

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Use of PRO questionnaire in general practice

Participants are people with type 2 diabetes, receiving treatment in GP. 30 GPs will be recruited from the Regions of Central Jutland, Zealand, and Southern Denmark, and from here, about 2,000 people (+18) with T2D are recruited. The 30 participating GPs will be randomly assigned to either the intervention (15 GPs) or control (15 GPs) group. The annual consultations in the intervention group will be based on responses to a diabetes-specific PRO questionnaire (PRODIAP) from the persons with T2D, while the control group will follow the usual process without PRODIAP.

Locations (1)

Steno Diabetes Center Aarhus

Aarhus, Denmark