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

2026年8月14日 更新者：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:

  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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

2000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Katrine B Bonnén, MSc in Public Health
  • 邮箱：KATBON@rm.dk

学习地点

  • 丹麦
      • Aarhus、丹麦、8200
        • 招聘中
        • steno diabetes center Aarhus
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • none

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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
行为的：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.
无干预：Type 2 diabetes patients_control
Patients in general practices randomised to the control group

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Patient Assessment Chronic Illness Care (PACIC)
大体时间："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
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

次要结果测量

结果测量
措施说明
大体时间
Hemoglobin A1C (HbA1c)
大体时间："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
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

其他结果措施

结果测量
措施说明
大体时间
Health related quality of live (EQ-5D-5L)
大体时间："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
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)
大体时间："through study completion, an average of 1½ year"
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"

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Aarhus

合作者

Aarhus University Hospital
Steno Diabetes Center Sjaelland
Steno Diabetes Center Odense

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月1日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2025年12月4日

首先提交符合 QC 标准的

2026年8月14日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月14日

最后验证

2025年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PRODIAP

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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