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Effect of the My Diabetes Care Patient Portal Intervention on Clinical Outcomes

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ClinicalTrials.gov Identifier: NCT05451914
Recruitment Status : Not yet recruiting
First Posted : July 11, 2022
Last Update Posted : August 9, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
William Martinez, MD, MS, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: My Diabetes Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Patient Portal Innovation to Engage Patients in Diabetes Care: A Pragmatic, Parallel-design, Randomized Controlled Trial
Estimated Study Start Date : April 1, 2023
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : February 28, 2025

Arm Intervention/treatment
Experimental: My Diabetes Care
Patients have access to an existing patient web portal (i.e., Epic's MyChart) embedded with My Diabetes Care.
Other: My Diabetes Care
My Diabetes Care (MDC) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate and tailored diabetes self-care information.
Other Name: Patient-facing Diabetes Dashboard

No Intervention: Usual Care
Patients will have access to an existing patient web portal (i.e., Epic's MyChart) NOT embedded with My Diabetes Care (i.e., usual care)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    Participants' most recent body mass index (BMI) measurement will be abstracted from participants' electronic medical record.

  2. Change in Low Density Lipoprotein (LDL) [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    Participants' most recent low density lipoprotein (LDL) measurement will be abstracted from participants' electronic medical record.

  3. Urine Albumin-to-Creatinine Ratio [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    Participants' most albumin-to-creatinine ratio will be abstracted from participants' electronic medical record.

  4. Change in Blood Pressure Control [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    Participants' most recent blood pressure measurement will be abstracted from participants' electronic medical record and will be used to calculate the participants' mean arterial pressure (MAP) using the following formula: MAP = diastolic pressure + 1/3(systolic pressure - diastolic pressure).

  5. Change in Diabetes Self-Care (General Diet Adherence) [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess general diet adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. An example item includes "How many of the last SEVEN DAYS have you followed a healthful eating plan?" The general diet subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).

  6. Change in Diabetes Self-Care (Exercise Adherence) [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The exercise subscale is used to assess exercise adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. An example item includes "On how many of the last SEVEN DAYS did you participate in at least 30 minutes of physical activity?" The exercise subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).

  7. Change in Diabetes Self-Care (Diabetes Medication Adherence) [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    The Adherence to Refills and Medications Scale-Diabetes (ARMS-D) is a reliable and valid measure of diabetes medication adherence. The 11-item ARMS-D has good internal consistency reliability (α=0.86). Responses range from 1="none of the time" to 4="all of the time," and are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence.

  8. Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess self-monitoring of blood glucose adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. An example item includes "On how many of the last SEVEN DAYS did you test your blood sugar?" The blood-glucose testing subscale is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).

  9. Usability of MyChart (for Control Group) [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    The usability of the patient portal (Epic's MyChart) will be assessed using the System Usability Scale (SUS). The SUS is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability.

  10. Satisfaction/Usability of My Diabetes Care (for Intervention Group) [ Time Frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3) ]
    The usability of the My Diabetes Care will be assessed using the System Usability Scale (SUS). The SUS is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or Brigham and Women's Hospital
  • Able to speak and read in English or Spanish
  • Reliable access to a smartphone or tablet with internet access
  • Active patient web portal account (for example, My Health at Vanderbilt or Patient Gateway)

Exclusion Criteria:

  • Have a medical condition that affects your memory or ability to think
  • Have severe difficulty seeing or hearing
  • Have a medical condition that makes it hard for people to understand what you are saying

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05451914


Contacts
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Contact: Audriana Nigg, BA (Study Coordinator) 615-933-3645 mdcmobilestudy@vumc.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Contact: Study Coordinator    615-933-3645    mdcmobilestudy@vumc.org   
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Contact: Study Coordinator    615-933-3645    mdcmobilestudy@vumc.org   
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: William Martinez, MD, MS Vanderbilt University Medical Center
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Responsible Party: William Martinez, MD, MS, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT05451914    
Other Study ID Numbers: R01DK131129 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2022    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After study results are posted on clinical trials and published in a peer-reviewed journal, de-identified individual participant data that underlie the results reported will be available upon requests made to the principal investigator and ending after 36 months after publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Deidentified individual participant data that underlie the results reported will be available after publication in a peer-reviewed journal and posted on clinical trials and ending after 36 months of publication.
Access Criteria: Researchers should provide a methodologically sound proposal to achieve their proposed aims. Proposals may be submitted to the principal investigator up to 36 months following publication. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William Martinez, MD, MS, Vanderbilt University Medical Center:
Diabetes
Patient Web Portals
Health Information Technology
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases