Usability of Diabetes Dashboard Embedded Within a Patient Web Portal

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Usability of Diabetes Dashboard Embedded Within a Patient Web Portal: A Prospective Longitudinal Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Patient-facing Diabetes Dashboard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. | Other: Patient-facing Diabetes Dashboard<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usage Data | This is a composite outcome measure of participants' self-reported 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). | one month follow-up (T1) | 
| Change in Diabetes Knowledge | The Short Diabetes Knowledge Instrument (SDKI) was used to measure diabetes knowledge including diabetes diet, symptoms of hypoglycemia, foot care and importance of physical activity. The SDKI is a 13-item scale with scores ranging from 0 to 13 representing number of items answered correctly. The Short Diabetes Knowledge Instrument (SDKI) will be administered to all study patients at enrollment (T0) and one month follow-up (T1). | enrollment (T0) and one month follow-up (T1) | 
| Change in Diabetes Self-Care | Diabetes self-care will be measured using the Summary of Diabetes Self-Care Activities (SDSCA), an 11-item questionnaire of diabetes self-management that assess the following six aspects of the diabetes regimen: general diet (2 items), specific diet (2 items), exercise (2 items), blood-glucose testing (2 items), foot care (2 items), and smoking (1 items). Item responses use the metric days per week except for a single item about smoking status which is yes or no. Each of the five aspects (excluding smoking) is assigned a mean score based on number of days per week. The Summary of Diabetes Self-Care Activities (SDSCA) will be administered to all study patients at enrollment (T0) and one month follow-up (T1). | enrollment (T0) and one month follow-up (T1) | 
| Change in Diabetes Self-Efficacy | 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. | enrollment (T0) and one month follow-up (T1) | 
| Change in Diabetes Distress | 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. | enrollment (T0) and one month follow-up (T1) | 
| Change in Knowledge of Diabetes Measures | 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). | enrollment (T0) and one month follow-up (T1) | 
| Change in Diabetes Understanding | 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 self-care (e.g., diet for blood sugar control). We administered 9 of the 13 items to study participants, excluding items that referenced elements of self-management that are not covered in My Diabetes Care (e.g., pregnancy and diabetes). Respondents rate their understanding on a five-point Likert scale. The scale scores range from 1 to 5 and represents the average item score for the scale (∑ Q1-9/ Count of non-missing items). High scores indicate higher perceived understanding. | enrollment (T0) and one month follow-up (T1) | 
| Change in Attitudes | 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). | enrollment (T0) and one month follow-up (T1) | 
| Change in Patient Activation | The Patient Activation Measure® (PAM-13) scale will be administered to all study participants at enrollment (T0) and one month follow-up (T1). The 13-item PAM® survey 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® survey 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). | enrollment (T0) and one month follow-up (T1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Patient Web Portals, Usability, Health Information Technology