My Diabetes Care Mobile: A Usability Study

NCT04894916 | Completed Results

• 2 other identifiers: 2022681R03DK119735
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; Self-efficacy; Patient Web Portals

Outcome Measures

Primary Outcomes (3)

• Usability

  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).

  One-month follow-up

• System Usage Data

  Self-reported usage of My Diabetes Care to include total number of participants who visited MDC-m during the study period and total number of participants with who used MDC-m for 10 minutes or more during the study period.

  One-month follow-up

• User Experience

  Unique study specific items to assess participants' perspectives on the usefulness of particular My Diabetes Care features and functionality.

  One-month follow-up

Secondary Outcomes (11)

• Change in Diabetes Knowledge

  Baseline to one-month follow-up

• Change in Diabetes Self-Efficacy

  Baseline to one-month follow-up

• Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures

  Baseline to one-month follow-up

• Change in Diabetes Distress

  Baseline to one-month follow-up

• Change in Diabetes Attitudes

  Baseline to one-month follow-up

Study Arms (1)

My Diabetes Care Mobile (MDC-m)

EXPERIMENTAL

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)

Interventions

My Diabetes Care Mobile (MDC-m) OTHER

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.

Also known as: Patient-facing Diabetes Dashboard

My Diabetes Care Mobile (MDC-m)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus
• Currently taking at least one medication for diabetes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: William Martinez, MD
• Organization: Vanderbilt University Medical Center

william.martinez@vumc.org

(615) 936-1010

Study Officials

• William Martinez, MD, MS

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 20, 2021
• Study Start: June 12, 2021
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: November 10, 2022
• Results First Posted: November 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)