Trial Outcomes & Findings for Usability of Diabetes Dashboard Embedded Within a Patient Web Portal (NCT NCT03786718)

NCT ID: NCT03786718

Last Updated: 2023-05-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

one month follow-up (T1)

Results posted on

2023-05-06

Participant Flow

Of the 69 enrolled participants, 67 completed the baseline questionnaire and were with given access to the intervention. Two participants never completed the baseline questionnaire despite reminders and therefore did not receive access to the intervention and were withdrawn.

Participant milestones

Participant milestones
Measure
Intervention
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Overall Study
STARTED
67
Overall Study
COMPLETED
60
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Overall Study
Lost to Follow-up
3
Overall Study
Withdrawal by Subject
1
Overall Study
Did not use the intervention
2
Overall Study
diagnosis changed from type 2 to type 1
1

Baseline Characteristics

One participant did not complete the eHEALS scale

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=60 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Age, Categorical
<=18 years
0 Participants
n=60 Participants
Age, Categorical
Between 18 and 65 years
40 Participants
n=60 Participants
Age, Categorical
>=65 years
20 Participants
n=60 Participants
Age, Continuous
57.5 years
STANDARD_DEVIATION 13.0 • n=60 Participants
Sex: Female, Male
Female
33 Participants
n=60 Participants
Sex: Female, Male
Male
27 Participants
n=60 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=60 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
58 Participants
n=60 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=60 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=60 Participants
Race (NIH/OMB)
Asian
1 Participants
n=60 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=60 Participants
Race (NIH/OMB)
Black or African American
13 Participants
n=60 Participants
Race (NIH/OMB)
White
41 Participants
n=60 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=60 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=60 Participants
Region of Enrollment
United States
60 participants
n=60 Participants
Education
High school/GED
5 Participants
n=60 Participants
Education
Some college/technical school
24 Participants
n=60 Participants
Education
College degree
19 Participants
n=60 Participants
Education
Graduate or professional degree
12 Participants
n=60 Participants
Health Literacy
Adequate
31 Participants
n=60 Participants
Health Literacy
Limited
29 Participants
n=60 Participants
eHealth Literacy
31.5 units on a scale
STANDARD_DEVIATION 5.2 • n=59 Participants • One participant did not complete the eHEALS scale
Patient Portal Usage
Weekly
26 Participants
n=60 Participants
Patient Portal Usage
Monthly
29 Participants
n=60 Participants
Patient Portal Usage
Other
5 Participants
n=60 Participants
Computer and Smartphone Usage
Desktop
50 participants
n=60 Participants
Computer and Smartphone Usage
Tablet
40 participants
n=60 Participants
Computer and Smartphone Usage
Smartphone
52 participants
n=60 Participants
Hemoglobin A1c
7.5 %
STANDARD_DEVIATION 1.6 • n=58 Participants • Two participants were missing hemoglobin A1C data.
Insulin Use
Yes
24 Participants
n=60 Participants
Insulin Use
No
36 Participants
n=60 Participants
Time with diagnosis of diabetes
13.1 years
STANDARD_DEVIATION 10.0 • n=60 Participants
Comorbidities
Hyperlipidemia
47 participants
n=60 Participants
Comorbidities
Hypertension
51 participants
n=60 Participants

PRIMARY outcome

Timeframe: one month follow-up (T1)

Population: All 60 participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires.

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.

Outcome measures

Outcome measures
Measure
Intervention
n=60 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Usability
78.8 score on a scale
Interval 72.5 to 87.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention
n=60 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
User Experience - Quantitative
Hover Over Info Icons - useful
26 participants
User Experience - Quantitative
Goal, Caution, and Warning Ranges - useful
46 participants
User Experience - Quantitative
Patients Like Me Data - useful
40 participants
User Experience - Quantitative
Literacy Sensitive Education Links - useful
40 participants
User Experience - Quantitative
Diabetes Online Community - useful
22 participants
User Experience - Quantitative
Star Status Indicator - understanding
18 participants
User Experience - Quantitative
Hover Over Info Icons - understanding
31 participants
User Experience - Quantitative
Goal, Caution, and Warning Ranges - understanding
39 participants
User Experience - Quantitative
Literacy Sensitive Education Links - understanding
39 participants
User Experience - Quantitative
Star Status Indicator - removed
4 participants
User Experience - Quantitative
Hover Over Info Icons - removed
0 participants
User Experience - Quantitative
Goal, Caution, and Warning Ranges - removed
2 participants
User Experience - Quantitative
Patients Like Me Data - removed
4 participants
User Experience - Quantitative
Star Status Indicator - useful
19 participants
User Experience - Quantitative
Diabetes Online Community - understanding
15 participants
User Experience - Quantitative
Literacy Sensitive Education Links - removed
0 participants
User Experience - Quantitative
Diabetes Online Community - removed
1 participants
User Experience - Quantitative
Intend to use going forward
60 participants

PRIMARY outcome

Timeframe: one month follow-up (T1)

Population: participants that participated in a semi-structured interview

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.

Outcome measures

Outcome measures
Measure
Intervention
n=14 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
User Experience - Qualitative
5 areas for improvement identified

SECONDARY outcome

Timeframe: one month follow-up (T1)

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).

Outcome measures

Outcome measures
Measure
Intervention
n=60 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
System Usage Data
Total minutes spent: 5-9 minutes
7 Participants
System Usage Data
Total minutes spent: 10-14 minutes
19 Participants
System Usage Data
Total number of visits: 1-2
12 Participants
System Usage Data
Total number of visits: 3-4
27 Participants
System Usage Data
Total number of visits: 5-6
12 Participants
System Usage Data
Total number of visits: 7+
9 Participants
System Usage Data
Total minutes spent: <5 minutes
4 Participants
System Usage Data
Total minutes spent: 15+ minutes
30 Participants
System Usage Data
Used literacy sensitive education links
51 Participants
System Usage Data
Used secure messaging
10 Participants
System Usage Data
Used diabetes online community
16 Participants
System Usage Data
Used info icon with explanation of health measure
49 Participants

SECONDARY outcome

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

Population: Missing data for one participant

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).

Outcome measures

Outcome measures
Measure
Intervention
n=59 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Change in Diabetes Knowledge
enrollment (T0)
11.0 score on a scale
Interval 10.0 to 12.0
Change in Diabetes Knowledge
one month follow-up (T1)
11.0 score on a scale
Interval 10.0 to 12.0

SECONDARY outcome

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

Population: The overall number of participants analyzed for two blood-glucose testing items was 50, because 10 participants that do not test their blood sugar were excluded from those two items. Overall number of participants analyzed was 60 for the the other five aspects/sub-scales.

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).

Outcome measures

Outcome measures
Measure
Intervention
n=60 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Change in Diabetes Self-Care
general diet at enrollment (T0)
4.0 days per week
Interval 2.8 to 5.0
Change in Diabetes Self-Care
general diet at one month follow-up (T1)
4.0 days per week
Interval 3.5 to 5.0
Change in Diabetes Self-Care
specific diet at enrollment (T0)
3.5 days per week
Interval 2.0 to 5.0
Change in Diabetes Self-Care
specific diet at one month follow-up (T1)
4.0 days per week
Interval 2.5 to 5.0
Change in Diabetes Self-Care
exercise at enrollment (T0)
2.5 days per week
Interval 0.5 to 3.8
Change in Diabetes Self-Care
exercise at one month follow-up (T1)
2.3 days per week
Interval 1.3 to 4.0
Change in Diabetes Self-Care
blood-glucose testing at enrollment (T0)
5.3 days per week
Interval 3.0 to 7.0
Change in Diabetes Self-Care
blood-glucose testing at one month follow-up (T1)
6.0 days per week
Interval 3.0 to 7.0
Change in Diabetes Self-Care
foot care at enrollment (T0)
3.5 days per week
Interval 1.0 to 4.8
Change in Diabetes Self-Care
foot care at one month follow-up (T1)
3.0 days per week
Interval 1.0 to 5.0

SECONDARY outcome

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

Population: One participant had missing data.

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.

Outcome measures

Outcome measures
Measure
Intervention
n=59 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Change in Diabetes Self-Efficacy
enrollment (T0)
26.0 score on a scale
Interval 23.0 to 30.0
Change in Diabetes Self-Efficacy
one month follow-up (T1)
29.0 score on a scale
Interval 25.0 to 32.0

SECONDARY outcome

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

Population: Missing data for one participant.

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.

Outcome measures

Outcome measures
Measure
Intervention
n=59 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Change in Diabetes Distress
enrollment (T0)
5.0 score on a scale
Interval 2.0 to 9.0
Change in Diabetes Distress
one month follow-up (T1)
5.0 score on a scale
Interval 2.0 to 9.0

SECONDARY outcome

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

Population: As noted in the outcome measure data table below, the number analyzed for some items is less than 60 due to missing data.

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).

Outcome measures

Outcome measures
Measure
Intervention
n=60 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Change in Knowledge of Diabetes Measures
Identify goal range for A1c at T1
50 participants
Change in Knowledge of Diabetes Measures
Identify definition of A1c at T0
40 participants
Change in Knowledge of Diabetes Measures
Identify definition of A1c at T1
45 participants
Change in Knowledge of Diabetes Measures
Identify goal range for A1c at T0
50 participants
Change in Knowledge of Diabetes Measures
Identify definition of blood pressure at T0
43 participants
Change in Knowledge of Diabetes Measures
Identify definition of blood pressure at T1
46 participants
Change in Knowledge of Diabetes Measures
Identify goal range for blood pressure at T0
17 participants
Change in Knowledge of Diabetes Measures
Identify goal range for blood pressure at T1
28 participants
Change in Knowledge of Diabetes Measures
Identify definition of LDL cholesterol at T0
22 participants
Change in Knowledge of Diabetes Measures
Identify definition of LDL cholesterol at T1
25 participants
Change in Knowledge of Diabetes Measures
Identify goal range for LDL cholesterol at T0
15 participants
Change in Knowledge of Diabetes Measures
Identify goal range for LDL cholesterol at T1
31 participants
Change in Knowledge of Diabetes Measures
Identify definition of flu vaccine at T0
58 participants
Change in Knowledge of Diabetes Measures
Identify definition of flu vaccine at T1
59 participants
Change in Knowledge of Diabetes Measures
Identify frequency of flu vaccination at T0
58 participants
Change in Knowledge of Diabetes Measures
Identify frequency of flu vaccination at T1
59 participants

SECONDARY outcome

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

Population: Missing data for one participant

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.

Outcome measures

Outcome measures
Measure
Intervention
n=59 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Change in Diabetes Understanding
enrollment (T0)
3.4 score on a scale
Interval 3.0 to 4.0
Change in Diabetes Understanding
one month follow-up (T1)
3.7 score on a scale
Interval 3.0 to 4.0

SECONDARY outcome

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

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).

Outcome measures

Outcome measures
Measure
Intervention
n=60 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Change in Attitudes
Interested in social comparison info at T0
51 participants
Change in Attitudes
Interested in social comparison info at T1
46 participants
Change in Attitudes
Interested goal-based comparison info at T0
58 participants
Change in Attitudes
Interested goal-based comparison info at T1
59 participants
Change in Attitudes
Agree social comparison info is useful at T0
49 participants
Change in Attitudes
Agree social comparison info is useful at T1
46 participants
Change in Attitudes
Agree goal-based comparison info is useful at T0
59 participants
Change in Attitudes
Agree goal-based comparison info is useful at T1
57 participants

SECONDARY outcome

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

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).

Outcome measures

Outcome measures
Measure
Intervention
n=60 Participants
Patients have access to a patient web portal with the Patient-facing Diabetes Dashboard activated. Patient-facing Diabetes Dashboard: The Patient-facing Diabetes Dashboard (also known as My Diabetes Care) is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons), provides literacy level appropriate educational resources, and contains secure-messaging capability.
Change in Patient Activation
enrollment (T0)
64.3 score on a scale
Interval 55.6 to 72.5
Change in Patient Activation
one month follow-up (T1)
67.8 score on a scale
Interval 60.6 to 75.0

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Martinez, MD

Vanderbilt University Medical Center

Phone: (615) 936-1010

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place