Clinical trial NCT05451914: Effects of My Diabetes Care on Patient Outcomes
Official title: My Diabetes Care: A Pragmatic, Parallel-design, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Patient Web Portals
Health Information Technology
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-07-11
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in Blood Glucose Control
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Secondary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
measure: Change in Low Density Lipoprotein (LDL)
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
measure: Urine Albumin-to-Creatinine Ratio
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
measure: Change in Blood Pressure Control
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
measure: Change in Diabetes Self-Care (General Diet Adherence)
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
measure: Change in Diabetes Self-Care (Exercise Adherence)
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
measure: Change in Diabetes Self-Care (Diabetes Medication Adherence)
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
measure: Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
measure: Usability of MyChart (for Control Group)
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
measure: Satisfaction/Usability of My Diabetes Care (for Intervention Group)
timeFrame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William Martinez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: