Pilot Study Enhancing Telemedicine Care Delivery for Adults With Complex Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recruitment percentage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
- •Pregnant or planning to become pregnant in next 6 months
- •Currently enrolled in another diabetes management intervention study
研究组 & 干预措施
Enhanced Telemedicine Care
Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist, with additional multidisciplinary support from the diabetes care team.
干预措施: Enhanced Telemedicine for Type 2 Diabetes (Other)
Usual Care
Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols.
干预措施: Usual Telemedicine Endocrinology Care for T2D (Other)
结局指标
主要结局
Recruitment percentage
时间窗: 12 months
Percent of eligible patients approached who are enrolled
Loss to follow up
时间窗: 6 months
Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys
次要结局
- Recruitment rate(12 months)
- Eligibility percentage(12 months)
- Visit attendance(6 months)
- Number of between-visit contacts(6 months)
- Blood glucose data availability(6 months)
- Patient satisfaction with telemedicine diabetes care(6 months)
- Diabetes Treatment Satisfaction Questionnaire-static version(Baseline)
- Diabetes Treatment Satisfaction Questionnaire-change version(6 months)
- T2D Diabetes Distress Core Scale(Baseline and 6 months)
- HbA1c change(Baseline and 6 months)
- Prescription of guideline-based GLP-1 receptor agonist(Baseline and 6 months)
- Prescription of guideline-based SGLT2 inhibitor(Baseline and 6 months)
- Retinal examination(6 months)
- Urine protein testing(6 months)
- Immunization-pneumococcal(6 months)
- Immunization-influenza(6 months)
研究者
Margaret Zupa
Assistant Professor of Medicine
University of Pittsburgh