加强 T2D 远程医疗的试点研究
加强对复杂 2 型糖尿病成人患者的远程医疗护理服务的试点研究
The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is:
Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible?
Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes.
Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.
研究概览
地位
条件
详细说明
This pilot study will compare an intervention to deliver high-quality diabetes care through telemedicine for adults with type 2 diabetes who have additional chronic health conditions and use insulin with usual telemedicine care. The investigators will assess feasibility, patient satisfaction, and preliminary clinical outcomes.
Fifty adults will be recruited from primary care practices. Once patients are confirmed eligible, they will be consented and enrolled. Patients will be randomized to the intervention arm or usual telemedicine care, stratified by age (above or below 65 years) and rurality, as these factors are associated with technological literacy and broadband access, which may impact telemedicine use and outcomes. Both groups will complete baseline survey measures and baseline clinical data will be collected via chart review. As this is a pragmatic pilot trial, intervention components will be delivered by usual clinical providers and staff for the intervention group. The telemedicine care intervention will include 2-3 synchronous visits with endocrinology providers over 6 months plus additional visits with multidisciplinary providers on an individualized basis. Telemedicine care will proceed as usual for the control group.
The investigators will focus pilot trial outcomes on standard metrics to assess feasibility for a future large trial. The investigators will also measure preliminary clinical outcomes.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- adults 18 years or older
- Diagnosis of type 2 diabetes based on abbreviated ICD-10 code E11.X in medical record or self-report
- HbA1c greater than or equal to 8% based on most recent value at time of recruitment
- Patients must own or have access to a smart phone, tablet, or home computer with data or internet connection that allows access to video-based visits
- Patient must use insulin
- Patients must have >2 comorbid chronic health conditions
- Be able to provide informed consent
- Reside in Pennsylvania
Exclusion criteria:
-
Age over 80 based on date of birth in electronic medical record
-
Visit with an endocrinologist in the prior 1 years
-
Dementia, ESRD, malignancy based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
- Dementia: A81.0x, F01.5x, F02.8x, F03.9x, F10.27, F10.97, F13.27, F13.97, F18.97, F19.17, F19.27, F19.97, G30.x, G31.0x, G31.1, G31.83, G31.85
- Malignancy, except non-melanoma skin cancer: C00.x-C14.x, C15.x-C26.x, C3x.xx, C40.xx-C41.x, C43.x, C4A.xx, C45.x-C49.xx, C50.xxx, C51.x-C58, C60.x-C63.x, C64.x- C68.x, C69.xx-C72.x, C73-C76.x, C7A.xx, C80.xx-C96.x (except C90.x1, C91.x1, C92.x1, C93.x1, C94.x1, C95.x1)
- ESRD N18.6
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Type 1, gestational, or other diabetes based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
- Type 1 diabetes: E10.X
- Gestational diabetes: O24.X, E08.X
- Other diabetes: E09.X, E13.2
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Pregnant or planning to become pregnant in next 6 months
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Currently enrolled in another diabetes management intervention study
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 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:Enhanced Telemedicine Care
Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist, with additional multidisciplinary support from the diabetes care team. |
Telemedicine-based endocrinology specialty care for type 2 diabetes with multidisciplinary diabetes care team support including pre-visit preparation, in-visit support and self-management education, and post-visit follow-up. |
|
有源比较器:Usual Care
Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols. |
Routine telemedicine-based endocrinology specialty care for type 2 diabetes, generally consisting of synchronous virtual visit with an endocrinologist and additional support including self-management education on an individualized basis. |
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 |
|---|---|---|
|
Recruitment percentage
大体时间:12 months
|
Percent of eligible patients approached who are enrolled |
12 months
|
|
Loss to follow up
大体时间:6 months
|
Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment rate
大体时间:12 months
|
Number of patients recruited per month |
12 months
|
|
Eligibility percentage
大体时间:12 months
|
Percent of patients approached who are eligible |
12 months
|
|
Visit attendance
大体时间:6 months
|
Percent of scheduled visits completed per patient |
6 months
|
|
Number of between-visit contacts
大体时间:6 months
|
Number of successful and attempted patient contacts by clinicians between visits per patient |
6 months
|
|
Blood glucose data availability
大体时间:6 months
|
Number of telemedicine visits with blood glucose data available at visit per patient |
6 months
|
|
Patient satisfaction with telemedicine diabetes care
大体时间:6 months
|
Percent of patients reporting satisfied or very satisfied on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree" with the statement "Overall, I am satisfied with the quality of service being provided via telemedicine" with higher scores indicating greater satisfaction |
6 months
|
|
Diabetes Treatment Satisfaction Questionnaire-static version
大体时间:Baseline
|
Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The static version will be used at baseline. Items 1, 4, 5, 6, 7 & 8 are summed to produce a Treatment Satisfaction score (range:0 to 36). The higher the score, the greater the satisfaction with treatment. 'Perceived frequency of hyperglycaemia' (item 2) & 'Perceived frequency of hypoglycaemia' (item 3): Both rated: 6 ('most of the time') to 0 ('none of the time'). Here, lower scores indicate blood glucose levels closer to the ideal. Higher scores indicate problems. |
Baseline
|
|
Diabetes Treatment Satisfaction Questionnaire-change version
大体时间:6 months
|
Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The change version will be used at 6 months.Items 1, 4, 5, 6, 7 and 8 are summed to produce a Treatment Satisfaction (change) score (range: +18 to -18). The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Two remaining items ('Perceived change in frequency of hyperglycaemia' (item 2) and 'Perceived change in frequency of hypoglycaemia' (item 3)) are treated individually: Both rated: +3 ('much more of the time now') to -3 ('much less of the time now'). Here, negative scores indicate fewer problems with blood glucose levels. Positive scores indicate more problems than before. |
6 months
|
|
T2D Diabetes Distress Core Scale
大体时间:Baseline and 6 months
|
Change in total score of 8-item measure of diabetes-related distress over prior month from baseline to 6 months. The Diabetes Distress Core scale is scored by averaging the value for each item, ranked from 1 to 5 scale (score range 1-5), with higher scores indicating more distress. |
Baseline and 6 months
|
|
HbA1c change
大体时间:Baseline and 6 months
|
Change in glycemic control from baseline to 6 months |
Baseline and 6 months
|
|
Prescription of guideline-based GLP-1 receptor agonist
大体时间:Baseline and 6 months
|
Number of patients with indications for GLP-1 receptor agonist therapy who are prescribed the indicated medication |
Baseline and 6 months
|
|
Prescription of guideline-based SGLT2 inhibitor
大体时间:Baseline and 6 months
|
Number of patients with indications for SGLT2 inhibitor therapy who are prescribed the indicated medication |
Baseline and 6 months
|
|
Retinal examination
大体时间:6 months
|
Number of patients with documentation of retinal examination performed in last year in medical record |
6 months
|
|
Urine protein testing
大体时间:6 months
|
Number of patients with documentation of urine protein testing performed in last year in medical record |
6 months
|
|
Immunization-pneumococcal
大体时间:6 months
|
Number of patients with documentation of pneumococcal vaccination in medical record |
6 months
|
|
Immunization-influenza
大体时间:6 months
|
Number of patients with documentation of influenza vaccination in medical record |
6 months
|
合作者和调查者
调查人员
- 首席研究员:Margaret Zupa, MDMS、University of Pittsburgh
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- STUDY24060062
- K23DK135794 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
A deidentified dataset including limited demographic, encounter, laboratory result, clinical observations, medication orders, care utilization, and survey (intervention satisfaction, treatment satisfaction, diabetes distress) data will be created. To protect research participant identities, datasets will not include any potentially identifying participant information.
IPD 共享时间框架
The data will become available no later than 12 months and ending 36 months after the primary trial results are published.
IPD 共享访问标准
No access will be granted until the requesting investigator vetting process is completed including an IRB-approved protocol and data use agreement with the University of Pittsburgh.The data that may be shared includes: de-identified participant data, tables, figures, appendices, analysis plan, and protocol.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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