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My Diabetes Care Mobile: A Usability Study

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ClinicalTrials.gov Identifier: NCT04894916
Recruitment Status : Completed
First Posted : May 20, 2021
Last Update Posted : September 14, 2021
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 prospective, longitudinal study on the My Diabetes Care mobile (MDC-m) intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: My Diabetes Care Mobile (MDC-m) Not Applicable

Detailed Description:
Up to 65 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care mobile (MDC-m). My Diabetes Care mobile (MDC-m) 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), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care information. Patients will be invited by mail 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™) version 5.0.8. Study participants will complete questionnaires electronically via email using REDCap™ at two time points: baseline (T0) and one-month follow-up (T1). Participants will complete an baseline questionnaire (T0) including basic demographic questions, items about computer usage and internet access, and validated measures of health literacy and eHealth literacy. Each participant will have access to the MDC-m for 1 month.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The My Diabetes Care Patient Portal Intervention for Mobile Devices: A Usability Study
Actual Study Start Date : June 12, 2021
Actual Primary Completion Date : August 27, 2021
Actual Study Completion Date : August 27, 2021

Arm Intervention/treatment
Experimental: My Diabetes Care Mobile (MDC-m)
Patients have access to a patient web portal embedded with the My Diabetes Care Mobile (MDC-m) intervention.
Other: My Diabetes Care Mobile (MDC-m)
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), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care information.
Other Name: Patient-facing Diabetes Dashboard




Primary Outcome Measures :
  1. Usability [ Time Frame: One-month follow-up ]
    The System Usability Scale (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. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).

  2. System Usage Data [ Time Frame: One-month follow-up ]
    User analytics for My Health at Vanderbilt and My Diabetes Care will be captured during the study period and will include: participants' total number of MDC-m visits, total duration of MDC-m visits, number of health data-related tasks performed (e.g., clicks on specific health data such as most recent LDL cholesterol), and number of informational-seeking tasks performed (e.g., click links to embedded educational materials).

  3. User Experience [ Time Frame: One-month follow-up ]
    Unique study specific items to assess participants' perspectives on content, layout, acceptance, and particular features and functionality.


Secondary Outcome Measures :
  1. Change in Diabetes Knowledge [ Time Frame: Baseline to one-month follow-up ]
    The Short Diabetes Knowledge Instrument (SDKI) is a valid measure of diabetes knowledge with an emphasis on controlling blood glucose through diet, recognizing symptoms of abnormal blood glucose, and using healthy eating to prevent complications. It also includes items on foot care and the importance of physical activity for preventing cardiovascular complications. The SDKI is a uni-dimensional, 13-item scale with scores ranging from 0 to 13 (number of items answered correctly). SDKI demonstrated good internal consistency reliability (Cronbach's alpha 0.73) in a multi-ethnic sample of older adults suggesting the instrument can be used to measure diabetes knowledge in diverse populations (Quandt et al. Diabetes Educator, 2014).

  2. Change in Diabetes Self-Care [ Time Frame: Baseline to one-month follow-up ]
    The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 12-item multidimensional instrument to assess levels of diabetes self-care across five domains: overall diet (2 items), dietary intake of specific foods (3 items), exercise (3 items), medication taking (2 items), and SMBG (2 items). The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes "How often did you follow your recommended diet over the last 7 days?" All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).

  3. Change in Diabetes Self-Efficacy [ Time Frame: Baseline to one-month follow-up ]
    The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. PDSMS has excellent internal consistency reliability (Cronbach's alpha of 0.83). PDSMS scores were associated with observed percentage of low blood sugars (r = .21), BMI (r = -.22), percentage of high blood sugars (r = -.36), average blood glucose (r = -.27), and A1C (r = -.25). Thus, the PDSMS appears to be validly associated with important self-management behaviors as well as with indicators of health status and diabetes control.

  4. Change in Medication Adherence [ Time Frame: Baseline to one-month follow-up ]
    The Adherence to Refills and Medications Scale is a reliable and valid measure of medication adherence. The 12-item ARMS has good internal consistency reliability (α=0.81). 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.

  5. Change in Diabetes Distress [ Time Frame: Baseline to one-month follow-up ]
    The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The five-item, uni-dimensional scale has scores that range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. The PAID-5 has excellent excellent internal consistency reliability (Cronbach's alpha 0.86) and is associated with measures of depression and hemoglobin A1c.

  6. Change in Knowledge of Diabetes Measures [ Time Frame: Baseline to one-month follow-up ]
    Unique study specific items to assess participants' knowledge of measures of diabetes health status (i.e., Hemoglobin A1C, blood pressure, low-density lipoprotein, and flu vaccination status). Each multiple choice item has one correct answer and the unit of measure is the percent of items answered correctly.

  7. Change in Diabetes Attitudes [ Time Frame: Baseline to one-month follow-up ]
    Unique study specific items to assess participants' attitudes toward social comparisons (2 items) and goal-based comparisons (2 items) regarding their diabetes health status. Each items is scored on a 5-point Likert scale from '1=strongly disagree' to '5=strongly agree'.

  8. Change in Diabetes Readiness for Change [ Time Frame: Baseline to one-month follow-up ]
    Four-item assessment of stage of change based on the Transtheoretical Model (TTM) of behavior change. It includes questions one item each assessing the participants stage of change for: (1) physical activity, (2) medication management, (3) glucose self-monitoring, and (4) diet. There are five response options per item that categorize the participants' current TTM stage of change for the item: (a) Precontemplation, (b) Contemplation, (c) Preparation, (d) Action, and (e) Maintenance.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Age 21 or over
  • Able to speak and read in English
  • Reliable access to a smartphone or tablet with internet access
  • 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
  • Patients with unintelligible speech (e.g., dysarthria)
  • Currently participating in another diabetes-related research study

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): NCT04894916


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
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: NCT04894916    
Other Study ID Numbers: 202268
1R03DK119735 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
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 after 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 Mellitus
Self-efficacy
Patient Web Portals
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases