My Diabetes Care: A Pragmatic, Parallel-design, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 458
- Locations
- 2
- Primary Endpoint
- Change in Blood Glucose Control
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care (MDC), to evaluate its effect on clinical outcomes.
Detailed Description
484 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 242 will be assigned to the intervention (My Diabetes Care) embedded within an existing patient web portal, My Health at Vanderbilt at Vanderbilt University Medical Center or Patient Gateway at Brigham and Women's Hospital. 242 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt or Patient Gateway without the My Diabetes Care (MDC) application. Potentially eligible patients will be invited to be screened for enrollment in the study. Interested patients will be able to complete an electronic consent form and enroll online via Research Electronic Data Capture (REDCap). Outcomes data will be collected from patients at four time points: baseline (T0), three-month follow-up (T1), three-month follow-up (T2), six-month follow-up (T3), and twelve-month follow-up (T4). At each time point, study participants will complete questionnaires electronically via email using REDCap, participants' hemoglobin A1C level will be assess via home A1C test kits, and participants' diabetes health data will be abstracted from their electronic health record. Participants will be randomized to the intervention or control arm after their baseline data is collected.
Investigators
William Martinez, MD, MS
Assistant Professor of Medicine
Vanderbilt University Medical Center
Eligibility Criteria
Inclusion Criteria
- •Type 2 Diabetes Mellitus
- •Age 18-75 years old
- •Currently taking at least one medication for diabetes
- •Be a patient at Vanderbilt University Medical Center (VUMC) or Brigham and Women's Hospital (BWH)
- •Able to speak and read in English or Spanish
- •Have reliable access to a smartphone, tablet, or computer with internet access
- •Active patient web portal account (My Health at Vanderbilt at VUMC or Patient Gateway at BWH)
Exclusion Criteria
- •Receiving dialysis,
- •Pregnant or planning to become pregnant within the next year,
- •Living in a long-term care facility.
Outcomes
Primary Outcomes
Change in Blood Glucose Control
Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Hemoglobin A1c will assessed using mail-in home HbA1c test kits and participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.
Secondary Outcomes
- Change in Body Mass Index (BMI)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Usability of MyChart (for Control Group)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Diabetes Self-Care (Diabetes Medication Adherence)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Low Density Lipoprotein (LDL)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Blood Pressure Control(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Diabetes Self-Care (Exercise Adherence)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Urine Albumin-to-Creatinine Ratio(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Diabetes Self-Care (General Diet Adherence)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Satisfaction/Usability of My Diabetes Care (for Intervention Group)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))