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

NCT ID: NCT03947333

Last Updated: 2022-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2021-01-11

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.

Group Type EXPERIMENTAL

My Diabetes Care

Intervention Type OTHER

The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability.

Control

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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My Diabetes Care

The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability.

Intervention Type OTHER

Other Intervention Names

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Patient-facing Diabetes Dashboard

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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William Martinez, MD, MS

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Martinez, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34032578 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5K23DK106511

Identifier Type: NIH

Identifier Source: secondary_id

View Link

190825

Identifier Type: -

Identifier Source: org_study_id

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