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

NCT07767331 | Recruiting DMC

• 1 other identifier: PRODIAP
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.A qualitative study using observations and interviews to explore how PRODIAP shapes the consultation from both patient and professional perspectives.

Conditions

Type 2 Diabetes

Keywords

Patient Reported Outcome (PRO); General Practice (GP); Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hemoglobin A1C (HbA1c)

  "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 Outcomes (2)

• Health related quality of live (EQ-5D-5L)

  "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)

  "through study completion, an average of 1½ year"

Study Arms (2)

Type 2 diabetes patients_intervention

EXPERIMENTAL

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

Type 2 diabetes patients_control

NO INTERVENTION

Patients in general practices randomised to the control group

Interventions

Use of PRO questionnaire in general practice BEHAVIORAL

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.

Type 2 diabetes patients_intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Aarhus: lead
• Steno Diabetes Center Sjaelland: collaborator
• Aarhus University Hospital: collaborator
• Steno Diabetes Center Odense: collaborator

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Anette Andersen, MD, PhD

CONTACT

+4522135605; anette.andersen@rm.dk

Katrine B Bonnén, MSc in Public Health

CONTACT

KATBON@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: August 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 17, 2026

Record last verified: 2025-12

Locations

DK (1)