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Evaluation of a Patient Portal Intervention for Diabetes: A Pilot Randomized Controlled Trial

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: My Diabetes Care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03947333
190825
5K23DK106511 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

287 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

287 participants in 2 patient groups

Intervention
Experimental group
Description:
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.
Treatment:
Other: My Diabetes Care
Control
No Intervention group
Description:
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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