Pilot Study Enhancing Telemedicine Care Delivery for Adults With Complex Type 2 Diabetes
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- University of Pittsburgh
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Recruitment percentage
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Margaret Zupa
Assistant Professor of Medicine
University of Pittsburgh
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recruitment percentage
Time Frame: 12 months
Percent of eligible patients approached who are enrolled
Loss to follow up
Time Frame: 6 months
Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys
Secondary Outcomes
- 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)