PRODIAP - Patient-reported Outcomes in General Practice Among People With Type 2 Diabetes
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
type 2 diabetes
able to understand and answer a Danish questionnaire
Disqualifiers
none
Trial design
Design model
Parallel
Treatments tested in this trial
Use of PRO questionnaire in general practice
BehavioralParticipants 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.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Type 2 diabetes patients_interventionExperimental treatment 1 intervention
Group B: Type 2 diabetes patients_controlNo intervention 0 interventions
Trial outcomes
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
Time frame
"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 2Secondary outcomes
1
Hemoglobin A1C (HbA1c)
Average level of blood glucose over the past two to three months. Collected from laboratory data base
Time frame
"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 2Other outcomes
1
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.
Time frame
"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 22
Resource use (costs)
Resource use associated with the intervention and derived costs in the health care sector. Measured in DKK.
Time frame
"through study completion, an average of 1½ year"Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Steno Diabetes Center Odense
Collaborator
Steno Diabetes Center Sjaelland
Collaborator
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov