PRO-DIAB-1: Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- timkl
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
研究概览
简要总结
Amidst medical innovations, many Type 1 diabetes patients using advanced therapy show improved control but still suffer from diabetes-related distress. To tackle this, the investigators propose an "enhanced care" model involving healthcare providers and pharmacists. The study compares standard and enhanced care for Type 1 adults, focusing on the pharmacist's role.
The main question it aims to answer is : In patients with type 1 diabetes treated with pump or closed-loop therapy, does the improved enhanced care versus conventional layout improve diabetes-related distress at 12 months?
Participants will complete a monthly online questionnaire to assess their diabetes-related distress as well as their frequency of use of standard and enhanced care as well as the associated patient satisfaction.
详细描述
Amidst accelerating innovations in care and limited medical time, many patients with Type 1 diabetes treated by pump or closed-loop therapy appear to have improved glycaemic control, but still experience significant diabetes-related distress.
The investigators therefore propose that a new form of patient care service provided by a health service provider and the patient's pharmacist, as part of the new type of care called "enhanced care", could contribute to overcoming this challenge.
This study compares two different care services provided to adult patients with Type 1 diabetes (PwT1D) treated with an insulin pump or a closed-loop system, known as standard care and enhanced care, the main difference between which lies in the pharmacist's involvement in the enhanced care model.
The originality of this project lies in several points:
- Firstly, it involves evaluating a new care model called enhanced care, which has the original feature of including the involvement of the patient's dispensing pharmacist.
- The role of home support providers in the psychological aspects of diabetes is poorly documented in the scientific literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be an adult (age ≥ 18 years)
- •Have Type 1 diabetes
- •Have been on closed-loop or insulin pump therapy for ≥ 6 months
- •Be in moderate or high diabetes-related distress defined as a DDS2 score ≥ 6
- •Be able to understand and complete questionnaires in French
- •Be affiliated to the general French Social Security system
- •Have an e-mail address
- •Have a cell phone number
- •Non-inclusion criteria:
- •Be deprived of liberty, under guardianship or curatorship
- •Not have Internet access or a cell phone
- •Have benefited or are already benefiting from the Enhanced Care program
- •Participating in an interventional study on a medical device for diabetes (pump, sensors, etc.)
- •Patients who are not regularly monitored in the investigating center proposing to include them, or who are likely to change centers or move to a different living area (pharmacy) within a year of inclusion.
排除标准
- 未提供
结局指标
主要结局
Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
时间窗: Baseline visit (Month 0) to Final visit (Month 12)
Compare patient-reported levels of diabetes-related distress at 12 months. Higher T1-DDS-7 scores indicate higher levels of diabetes-related distress.
次要结局
- A.1 Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care](Baseline (Month 0) to Month 6)
- A.2 Change in the sub-scores of the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care](Baseline (Month 0) to Month 12)
- B.1b Frequency of patients' interactions with the home support provider(monthly between Baseline (Month 0) and Month 12)
- B.1c Satisfaction with specific aspects of the services provided by the home support provider(monthly between Baseline (Month 0) and Month 12)
- B.2a (Intervention group only) Number of pharmacy visits(monthly between Baseline (Month 0) and Month 12)
- B.3d Patient assessment of how representatives of the home support provider treat confidential information(at Month 6 and at Month 12)
- B.5c (intervention group) Pharmacist satisfaction with the number of interactions with patients(Month 12)
- B.2b (Intervention group only) Duration of pharmacy visits(monthly between Baseline (Month 0) and Month 12)
- B.2c (Intervention group only) Description of clinical or non-clinical events impacting diabetes(monthly between Baseline (Month 0) and Month 12)
- A.3a Evolution of the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care](quarterly between Baseline (Month 0) and Month 12)
- A.3b Evolution of the 2-question Diabetes Distress Score (DDS2) [Comparison: Enhanced Care vs Standard Care](8 times between Baseline (Month 0) and Month 12)
- B.1a Patient overall satisfaction with services provided by the home support provider(monthly between Baseline (Month 0) and Month 12)
- B.3a Patients' Perceived Effectiveness of Patient-Physician Interactions (PEPPI questionnaire)(at Month 6 and at Month 12)
- B.3b Patient Assessment of Chronic Illness Care (PACIC questionnaire)(at Baseline (Month 0) and at Month 12)
- B.3c Patient assessment of information flow and transparency(at Month 6 and at Month 12)
- B.5a (intervention group) Pharmacist satisfaction with the services provided by the home support provider to their patients(Month 12)
- B.5b (intervention group) Pharmacist satisfaction with the length of interactions with patients(Month 12)
- B.5d (intervention group) Pharmacist perception of the usefulness of their increased role in diabetes management(Month 12)
- C.3a Patient satisfaction with treatment as measured by the Diabetes Treatment Satisfaction Questionnaire - status (DTSQs) [Comparison: Enhanced Care vs Standard Care](Baseline (Month 0) and at Month 12)
- B.4b Specialist Physician satisfaction with quantity and pertinence information provided by the home support provider on their patients(Month 12)
- C.1 Self-reported ability to use their insulin delivery system(pump or closed loop) [Comparison: Enhanced Care vs Standard Care](monthly from Baseline (Month 0) to Month 12)
- Physician assessment of patient's ability to use their insulin delivery system (pump or closed loop [Comparison: Enhanced Care vs Standard Care](Month 12)
- C.3b Patient perception of treatment burden [Comparison: Enhanced Care vs Standard Care](Baseline (Month 0) and at Month 12)
- D.1 Time in the glycemic target range [Comparison: Enhanced Care vs Standard Care](Month 12)
- B.4a Specialist Physician satisfaction with the services provided by the home support provider to their patients(Month 12)
- E.1 Patient quality of life [Comparison: Enhanced Care vs Standard Care](at Baseline (Month 0) and at Month 12)
- Percentage of glycated hemoglobin (HbA1c) [Comparison: Enhanced Care vs Standard Care](at Baseline (Month 0) and at Month 12)
- E.2 Number and relevance of impact that can have an impact on diabetes [Comparison: Enhanced Care vs Standard Care](monthly between Baseline (Month 0) and Month 12)