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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Use of PRO questionnaire in general practice

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anette Andersen, MD, PhD; Phone Number: +4522135605; Email: anette.andersen@rm.dk
• Study Contact Backup: Name: Katrine B Bonnén, MSc in Public Health; Email: KATBON@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • steno diabetes center Aarhus
    • Contact: Anette Andersen, MD, PhD; Phone Number: +4522135605; Email: anette.andersen@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• type 2 diabetes
• able to understand and answer a Danish questionnaire

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.
No Intervention: Type 2 diabetes patients_control; Patients in general practices randomised to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment Chronic Illness Care (PACIC)	Patient Assessment of Chronic Illness Care (PACIC) assesses patient-perceived quality of care among individuals with T2D. PACIC consists of 20 items divided into five subscales with the following themes: patient activation, decision support, goal setting, problem-solving, and coordination/follow-up. PACIC is scored on a 5-point scale ranging from 1 (never) to 5 (always). The total PACIC score is calculated as the mean of all items and as the mean of the five subscales	"Baseline" - up to 2 weeks before the patients attend their yearly check-up at the general practitioner at year 1 "Endpoint" - up to 2 weeks after the patients attended their yearly check-up at the general practitioner at year 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C (HbA1c)	Average level of blood glucose over the past two to three months. Collected from laboratory data base	"Baseline" - up to 2 weeks before the patients attend their yearly check-up at the general practitioner at year 1 "Endpoint" - up to 2 weeks after the patients attended their yearly check-up at the general practitioner at year 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of live (EQ-5D-5L)	Health related quality of live is measured using the EQ-5D-5L which in turn is used to estimate quality-adjusted life year (QALY). EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	"Baseline" - up to 2 weeks before the patients attend their yearly check-up at the general practitioner at year 1 "Endpoint" - up to 2 weeks after the patients attended their yearly check-up at the general practitioner at year 2
Resource use (costs)	Resource use associated with the intervention and derived costs in the health care sector. Measured in DKK.	"through study completion, an average of 1½ year"

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Steno Diabetes Center Sjaelland; Steno Diabetes Center Odense

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: August 14, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Patient Reported Outcome (PRO); General Practice (GP)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PRODIAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No