NCT03786718

Brief Summary

The purpose of this study is to conduct a prospective, longitudinal study to evaluate the usability of a patient-facing diabetes dashboard delivered via an established patient web portal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

December 27, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 7, 2020

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

December 19, 2018

Results QC Date

May 8, 2020

Last Update Submit

May 5, 2023

Conditions

Keywords

DiabetesPatient Web PortalsUsabilityHealth Information Technology

Outcome Measures

Primary Outcomes (3)

  • Usability

    The System Usability Scale (SUS) will be administered to all study participants at one month follow-up (T1). The SUS is a validated measure of usability. 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). A score of above 68 indicative of "above average" usability.

    one month follow-up (T1)

  • User Experience - Quantitative

    User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). The survey items will inquire about participants' perspectives on particular features of the Patient-facing Diabetes Dashboard. Participants were asked to indicate which features, if any: (1) they found useful for managing their diabetes and which features, (2) improved their understanding of their diabetes health data, and (3) should be removed. In addition, participants indicated whether they intended to use the dashboard going forward if it remained available.

    one month follow-up (T1)

  • User Experience - Qualitative

    At the end of the study period (T1), a subset of study participants will be invited to complete a semi-structured interview to provide a deeper understanding of their experience using the dashboard.

    one month follow-up (T1)

Secondary Outcomes (9)

  • System Usage Data

    one month follow-up (T1)

  • Change in Diabetes Knowledge

    enrollment (T0) and one month follow-up (T1)

  • Change in Diabetes Self-Care

    enrollment (T0) and one month follow-up (T1)

  • Change in Diabetes Self-Efficacy

    enrollment (T0) and one month follow-up (T1)

  • Change in Diabetes Distress

    enrollment (T0) and one month follow-up (T1)

  • +4 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.

Other: Patient-facing Diabetes Dashboard

Interventions

The Patient-facing Diabetes Dashboard is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy level appropriate educational resources, and contains secure-messaging capability.

Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus
  • Currently being treated with at least one antihyperglycemic medication
  • Able to speak and read in English
  • Have reliable access to a computer with internet access
  • Existing My Health at Vanderbilt (i.e., patient portal) account

You may not qualify if:

  • Living in long term care facilities
  • Known cognitive deficits
  • Severe visual or hearing impairment
  • Unintelligible speech (e.g., dysarthria)
  • Currently participating in another diabetes-related research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Martinez

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
William Martinez, MD
Organization
Vanderbilt University Medical Center

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

December 19, 2018

First Posted

December 26, 2018

Study Start

December 27, 2018

Primary Completion

May 13, 2019

Study Completion

May 13, 2019

Last Updated

May 6, 2023

Results First Posted

July 7, 2020

Record last verified: 2023-05

Locations