Clinical trial NCT03947333: Evaluation of a Patient Portal Intervention for Diabetes: A Pilot Randomized Controlled Trial
Official title: Evaluation of a Patient Portal Intervention for Diabetes: A Two-arm, Parallel-Design, Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Patient Activation
Patient Web Portals
Health Information Technology
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-05-13
Enrollment: 287
Sex: ALL
Minimum age (years): 21
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, to evaluate its effect on patient activation and secondary cognitive, behavioral, and clinical outcomes.

Detailed description: 300 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 150 will be assigned to receive access to the intervention (My Diabetes Care) embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 150 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt without the My Diabetes Care. Patients will be invited by mail (or email) to be screened for enrollment in the study. Eligible and interested patients will be emailed a link to a secure study website where they will complete a web consent form. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being randomized to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month and 6-month follow-ups to assess outcomes. In addition, system usage will be collected.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Currently being treated with at least one antihyperglycemic medication
* Able to speak and read in English
* Reliable access to a computer (desktop or laptop) with internet capabilities
* Active VUMC patient web portal (known as My Health At Vanderbilt) account

Exclusion Criteria:

* Residing in a long term care facility
* Medical condition that affects my memory or ability to think.
* Severe visual impairment
* Currently participating in another diabetes-related research study

Primary outcomes:
measure: Change in Patient Activation at 6 Months
timeFrame: Baseline to 6-month follow-up
measure: Change in Patient Activation at 3 Months
timeFrame: Baseline to 3-month follow-up
Secondary outcomes:
measure: Change in Diabetes Self-Efficacy
timeFrame: Baseline, 3-month follow up, 6-month follow-up
measure: Change in Diabetes Knowledge
timeFrame: Baseline, 3-month follow up, 6-month follow-up
measure: Change in Diabetes Self-Care (General Diet Adherence)
timeFrame: Baseline, 3-month follow up, 6-month follow-up
measure: Change in Diabetes Self-Care (Specific Diet)
timeFrame: Baseline, 3-month follow up, 6-month follow-up
measure: Change in Diabetes Self-Care (Exercise Adherence)
timeFrame: Baseline, 3-month follow up, 6-month follow-up
measure: Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)
timeFrame: Baseline, 3-month follow up, 6-month follow-up
measure: Change in Diabetes Self-Care (Diabetes Medication Adherence)
timeFrame: Baseline, 3-month follow up, 6-month follow-up
measure: Change in Diabetes Distress
timeFrame: Baseline, 3-month follow up, 6-month follow-up
measure: Change in Blood Glucose Control
timeFrame: Baseline to 6-month follow-up
measure: Change in Blood Pressure Control
timeFrame: Baseline to 6-month follow-up
measure: Change in Flu Vaccination Status for 2019-20 Flu Season
timeFrame: Baseline, 3-month follow up
measure: Change in Low Density Lipoprotein
timeFrame: Baseline to 6-month follow-up
measure: Satisfaction/Usability of My Health at Vanderbilt (for Control Group)
timeFrame: Baseline, 3-month follow up, 6-month follow-up
measure: Satisfaction/Usability of My Diabetes Care (for Intervention Group)
timeFrame: 3-month follow up, 6-month follow-up
measure: System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)
timeFrame: 6-month follow-up
measure: System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)
timeFrame: 6-month follow-up
measure: System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)
timeFrame: 6-month follow-up
Other outcomes:
Locations:
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:
citation: Martinez W, Hackstadt AJ, Hickson GB, Rosenbloom ST, Elasy TA. Evaluation of the My Diabetes Care Patient Portal Intervention: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 May 25;10(5):e25955. doi: 10.2196/25955.