Diabetes Mellitus, Type 2NCT03786718
Usability of Diabetes Dashboard Embedded Within a Patient Web Portal
A study testing Patient-facing Diabetes Dashboard in people with Diabetes Mellitus, Type 2, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Patient-facing Diabetes Dashboard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2018to 13 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability of Diabetes Dashboard Embedded Within a Patient Web Portal: A Prospective Longitudinal Study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Patient-facing Diabetes Dashboard
- Keywords
- Diabetes, Patient Web Portals, Usability, Health Information Technology
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-facing Diabetes DashboardOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Receives: Other: Patient-facing Diabetes Dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: one month follow-up (T1)
Secondary outcomes (9)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: enrollment (T0) and one month follow-up (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start27 Dec 2018
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Martinez, MD, MS, Vanderbilt University Medical Center
- Investigators
- William Martinez, MD, MS, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786718
- Sponsor's protocol ID
- 181727
- Other IDs
- 5K23DK106511
- Status last verified
- May 2023
- First submitted
- 19 Dec 2018
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of Diabetes Dashboard Embedded Within a Patient Web Portal: A Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT03786718
- Acronym / sponsor ID
- 181727
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Patient Web Portals, Usability, Health Information Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Patient-facing Diabetes DashboardPatients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-facing Diabetes DashboardThe 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. | Other | Intervention |
Primary outcome
Usability
Time frame: one month follow-up (T1)
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.
User Experience - Quantitative
Time frame: one month follow-up (T1)
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.
User Experience - Qualitative
Time frame: one month follow-up (T1)
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.
9 secondary outcomes
System Usage Data
Time frame: one month follow-up (T1)
Change in Diabetes Knowledge
Time frame: enrollment (T0) and one month follow-up (T1)
Change in Diabetes Self-Care
Time frame: enrollment (T0) and one month follow-up (T1)
Change in Diabetes Self-Efficacy
Time frame: enrollment (T0) and one month follow-up (T1)
Change in Diabetes Distress
Time frame: enrollment (T0) and one month follow-up (T1)
Change in Knowledge of Diabetes Measures
Time frame: enrollment (T0) and one month follow-up (T1)
Change in Diabetes Understanding
Time frame: enrollment (T0) and one month follow-up (T1)
Change in Attitudes
Time frame: enrollment (T0) and one month follow-up (T1)
Change in Patient Activation
Time frame: enrollment (T0) and one month follow-up (T1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Martinez, MD, MS principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-facing Diabetes Dashboard in people with Diabetes Mellitus, Type 2, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: one month follow-up (T1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.