PRODIAP - Patient-reported Outcomes in General Practice Among People With Type 2 Diabetes (PRODIAP)
14 augusti 2026 uppdaterad av: University of Aarhus
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:
- 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.
- 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
2000
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Anette Andersen, MD, PhD
- Telefonnummer: +4522135605
- E-post: anette.andersen@rm.dk
Studera Kontakt Backup
- Namn: Katrine B Bonnén, MSc in Public Health
- E-post: KATBON@rm.dk
Studieorter
-
-
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Aarhus, Danmark, 8200
- Rekrytering
- steno diabetes center Aarhus
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Kontakt:
- Anette Andersen, MD, PhD
- Telefonnummer: +4522135605
- E-post: anette.andersen@rm.dk
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- type 2 diabetes
- able to understand and answer a Danish questionnaire
Exclusion Criteria:
- none
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
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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.
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Inget ingripande: Type 2 diabetes patients_control
Patients in general practices randomised to the control group
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Patient Assessment Chronic Illness Care (PACIC)
Tidsram: "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
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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
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"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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Hemoglobin A1C (HbA1c)
Tidsram: "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
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Average level of blood glucose over the past two to three months.
Collected from laboratory data base
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"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
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Health related quality of live (EQ-5D-5L)
Tidsram: "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
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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.
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"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
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Resource use (costs)
Tidsram: "through study completion, an average of 1½ year"
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Resource use associated with the intervention and derived costs in the health care sector.
Measured in DKK.
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"through study completion, an average of 1½ year"
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
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Studera stora datum
Studiestart (Faktisk)
1 mars 2026
Primärt slutförande (Beräknad)
1 februari 2028
Avslutad studie (Beräknad)
1 februari 2028
Studieregistreringsdatum
Först inskickad
4 december 2025
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2026
Första postat (Faktisk)
17 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 augusti 2026
Senast verifierad
1 december 2025
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PRODIAP
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