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Usability of Diabetes Dashboard Embedded Within a Patient Web Portal

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ClinicalTrials.gov Identifier: NCT03786718
Recruitment Status : Active, not recruiting
First Posted : December 25, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
William Martinez, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Patient-facing Diabetes Dashboard Not Applicable

Detailed Description:
Up to 70 adult patients with type 2 diabetes mellitus will be enrolled and given access to a diabetes dashboard within an existing patient web portal. Patients will be invited by mail (or email) to be screened for enrollment in the study. Patients may also respond at a study flyer and contact the study team to be screened for enrollment. Eligible and interested patients will be emailed a link to a secure study website where they will complete a web consent form. After enrollment, participants will complete a baseline web-based questionnaire. After completing the enrollment questionnaire, they will be provided access to the diabetes dashboard within the patient web portal for one month. After one month, participants will receive an additional follow-up (final) questionnaire to assess outcomes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Usability of Diabetes Dashboard Embedded Within a Patient Web Portal: A Prospective Longitudinal Study
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Intervention
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated.
Other: Patient-facing Diabetes Dashboard
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.




Primary Outcome Measures :
  1. Usability [ Time Frame: 1 month ]
    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 SUS score above a 68 would be considered above average and anything below 68 is below average.

  2. User Experience - Quantitative [ Time Frame: 1 month ]
    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 the content, layout, acceptance, and particular features and functionality of the Patient-facing Diabetes Dashboard.

  3. User Experience - Qualitative [ Time Frame: 1 month ]
    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.


Secondary Outcome Measures :
  1. System Usage Data [ Time Frame: 1 month ]
    This is a composite outcome measure of participants' total number of diabetes dashboard visits, total duration of dashboard use, use of embedded educational links, utilization of embedded functionality to secure message healthcare team member(s), and use of an embedded link to American Diabetes Association Online Community and will be queried at the end of the study period (T1).

  2. Change in Diabetes Knowledge [ Time Frame: 1 month ]
    The Short Diabetes Knowledge Instrument (SDKI) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).

  3. Change in Diabetes Self-Care [ Time Frame: 1 month ]
    The Summary of Diabetes Self-Care Activities (SDSCA) will be administered to all study patients at enrollment (T0) and one month follow-up (T1).

  4. Change in Diabetes Self-Efficacy [ Time Frame: 1 month ]
    The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy. The PDSMS will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Eight items are 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.

  5. Change in Diabetes Distress [ Time Frame: 1 month ]
    The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 will be administered to all study participants at enrollment (T0) and one month follow-up (T1). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.

  6. Change in Knowledge of Diabetes Measures [ Time Frame: 1 month ]
    Unique study specific items to assess participants' knowledge of measures of diabetes health status (e.g., Hemoglobin A1C) will be administered to all study participants at enrollment (T0) and one month follow-up (T1).

  7. Change in Diabetes Understanding [ Time Frame: 1 month ]
    The Diabetes Care Profile (DCP) is a self-administered questionnaire that assesses the social and psychological factors related to diabetes and its treatment. The instrument includes sixteen scales. The Understanding Scale of the DCP contains 13 items that assesses respondents' perceived understanding of elements of diabetes care (e.g., diet for blood sugar control). The Understanding Scale of the DCP will be administered to all study participants at enrollment (T0) and one month follow-up (T1). The scores range from 13 to 65 with higher scores indicating better perceived understanding of diabetes care.

  8. Change in Attitudes [ Time Frame: 1 month ]
    Unique study specific survey items to assess participants' attitudes toward receiving social and goal-based comparison information regarding their diabetes health status will be administered to all study participants at enrollment (T0) and one month follow-up (T1).

  9. Change in Patient Activation [ Time Frame: 1 month ]
    The Patient Activation Measure (PAM-13) scale will be administered to all study participants at enrollment (T0) and one month follow-up (T1). The PAM-13 is a validated measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care) and consists of 13 items. Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree to elicit endorsement of a particular statement. PAM-13 item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation).



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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
  • 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

Exclusion Criteria:

  • 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

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): NCT03786718


Locations
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United States, Tennessee
William Martinez
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
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, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03786718     History of Changes
Other Study ID Numbers: 181727
5K23DK106511 ( U.S. NIH Grant/Contract )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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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, Vanderbilt University Medical Center:
Diabetes
Patient Web Portals
Usability
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