Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Patient Web Portals, Usability, Health Information Technology
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.
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Self-Efficacy | enrollment (T0) and one month follow-up (T1) | 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. |
| Change in Diabetes Distress | enrollment (T0) and one month follow-up (T1) | 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. |
| Change in Knowledge of Diabetes Measures | enrollment (T0) and one month follow-up (T1) | 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). |
| System Usage Data | 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). |
| Change in Attitudes | 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). |
| Change in Patient Activation | 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). |
| Change in Diabetes Understanding | enrollment (T0) and one month follow-up (T1) | 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. |
| Change in Diabetes Knowledge | enrollment (T0) and one month follow-up (T1) | 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). |
| Change in Diabetes Self-Care | enrollment (T0) and one month follow-up (T1) | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | diagnosis changed from type 2 to type 1 | 1 |
| Overall Study | Did not use the intervention | 2 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 57.5 years STANDARD_DEVIATION 13 |
| Comorbidities Hyperlipidemia | 47 participants |
| Comorbidities Hypertension | 51 participants |
| Computer and Smartphone Usage Desktop | 50 participants |
| Computer and Smartphone Usage Smartphone | 52 participants |
| Computer and Smartphone Usage Tablet | 40 participants |
| Education College degree | 19 Participants |
| Education Graduate or professional degree | 12 Participants |
| Education High school/GED | 5 Participants |
| Education Some college/technical school | 24 Participants |
| eHealth Literacy | 31.5 units on a scale STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Health Literacy Adequate | 31 Participants |
| Health Literacy Limited | 29 Participants |
| Hemoglobin A1c | 7.5 % STANDARD_DEVIATION 1.6 |
| Insulin Use No | 36 Participants |
| Insulin Use Yes | 24 Participants |
| Patient Portal Usage Monthly | 29 Participants |
| Patient Portal Usage Other | 5 Participants |
| Patient Portal Usage Weekly | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 27 Participants |
| Time with diagnosis of diabetes | 13.1 years STANDARD_DEVIATION 10 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 67 |
| other Total, other adverse events | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 |
Outcome results
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.
Time frame: one month follow-up (T1)
Population: All 60 participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Usability | 78.8 score on a scale |
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.
Time frame: one month follow-up (T1)
Population: participants that participated in a semi-structured interview
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | User Experience - Qualitative | 5 areas for improvement identified |
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.
Time frame: one month follow-up (T1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | User Experience - Quantitative | Star Status Indicator - useful | 19 participants |
| Intervention | User Experience - Quantitative | Hover Over Info Icons - useful | 26 participants |
| Intervention | User Experience - Quantitative | Patients Like Me Data - useful | 40 participants |
| Intervention | User Experience - Quantitative | Hover Over Info Icons - removed | 0 participants |
| Intervention | User Experience - Quantitative | Goal, Caution, and Warning Ranges - removed | 2 participants |
| Intervention | User Experience - Quantitative | Patients Like Me Data - removed | 4 participants |
| Intervention | User Experience - Quantitative | Literacy Sensitive Education Links - removed | 0 participants |
| Intervention | User Experience - Quantitative | Diabetes Online Community - removed | 1 participants |
| Intervention | User Experience - Quantitative | Intend to use going forward | 60 participants |
| Intervention | User Experience - Quantitative | Goal, Caution, and Warning Ranges - understanding | 39 participants |
| Intervention | User Experience - Quantitative | Goal, Caution, and Warning Ranges - useful | 46 participants |
| Intervention | User Experience - Quantitative | Literacy Sensitive Education Links - useful | 40 participants |
| Intervention | User Experience - Quantitative | Diabetes Online Community - useful | 22 participants |
| Intervention | User Experience - Quantitative | Star Status Indicator - understanding | 18 participants |
| Intervention | User Experience - Quantitative | Hover Over Info Icons - understanding | 31 participants |
| Intervention | User Experience - Quantitative | Literacy Sensitive Education Links - understanding | 39 participants |
| Intervention | User Experience - Quantitative | Diabetes Online Community - understanding | 15 participants |
| Intervention | User Experience - Quantitative | Star Status Indicator - removed | 4 participants |
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).
Time frame: enrollment (T0) and one month follow-up (T1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Change in Attitudes | Interested in social comparison info at T0 | 51 participants |
| Intervention | Change in Attitudes | Interested in social comparison info at T1 | 46 participants |
| Intervention | Change in Attitudes | Interested goal-based comparison info at T0 | 58 participants |
| Intervention | Change in Attitudes | Interested goal-based comparison info at T1 | 59 participants |
| Intervention | Change in Attitudes | Agree social comparison info is useful at T0 | 49 participants |
| Intervention | Change in Attitudes | Agree social comparison info is useful at T1 | 46 participants |
| Intervention | Change in Attitudes | Agree goal-based comparison info is useful at T0 | 59 participants |
| Intervention | Change in Attitudes | Agree goal-based comparison info is useful at T1 | 57 participants |
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.
Time frame: enrollment (T0) and one month follow-up (T1)
Population: Missing data for one participant.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Change in Diabetes Distress | enrollment (T0) | 5.0 score on a scale |
| Intervention | Change in Diabetes Distress | one month follow-up (T1) | 5.0 score on a scale |
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).
Time frame: enrollment (T0) and one month follow-up (T1)
Population: Missing data for one participant
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Change in Diabetes Knowledge | enrollment (T0) | 11.0 score on a scale |
| Intervention | Change in Diabetes Knowledge | one month follow-up (T1) | 11.0 score on a scale |
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Change in Diabetes Self-Care | general diet at enrollment (T0) | 4.0 days per week |
| Intervention | Change in Diabetes Self-Care | general diet at one month follow-up (T1) | 4.0 days per week |
| Intervention | Change in Diabetes Self-Care | specific diet at one month follow-up (T1) | 4.0 days per week |
| Intervention | Change in Diabetes Self-Care | exercise at enrollment (T0) | 2.5 days per week |
| Intervention | Change in Diabetes Self-Care | blood-glucose testing at one month follow-up (T1) | 6.0 days per week |
| Intervention | Change in Diabetes Self-Care | foot care at enrollment (T0) | 3.5 days per week |
| Intervention | Change in Diabetes Self-Care | foot care at one month follow-up (T1) | 3.0 days per week |
| Intervention | Change in Diabetes Self-Care | specific diet at enrollment (T0) | 3.5 days per week |
| Intervention | Change in Diabetes Self-Care | exercise at one month follow-up (T1) | 2.3 days per week |
| Intervention | Change in Diabetes Self-Care | blood-glucose testing at enrollment (T0) | 5.3 days per week |
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.
Time frame: enrollment (T0) and one month follow-up (T1)
Population: One participant had missing data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Change in Diabetes Self-Efficacy | enrollment (T0) | 26.0 score on a scale |
| Intervention | Change in Diabetes Self-Efficacy | one month follow-up (T1) | 29.0 score on a scale |
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.
Time frame: enrollment (T0) and one month follow-up (T1)
Population: Missing data for one participant
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Change in Diabetes Understanding | enrollment (T0) | 3.4 score on a scale |
| Intervention | Change in Diabetes Understanding | one month follow-up (T1) | 3.7 score on a scale |
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Change in Knowledge of Diabetes Measures | Identify definition of A1c at T0 | 40 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify definition of A1c at T1 | 45 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify goal range for A1c at T0 | 50 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify goal range for A1c at T1 | 50 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify definition of blood pressure at T0 | 43 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify definition of LDL cholesterol at T0 | 22 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify definition of LDL cholesterol at T1 | 25 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify goal range for LDL cholesterol at T0 | 15 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify goal range for LDL cholesterol at T1 | 31 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify definition of flu vaccine at T0 | 58 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify definition of flu vaccine at T1 | 59 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify frequency of flu vaccination at T0 | 58 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify frequency of flu vaccination at T1 | 59 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify definition of blood pressure at T1 | 46 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify goal range for blood pressure at T0 | 17 participants |
| Intervention | Change in Knowledge of Diabetes Measures | Identify goal range for blood pressure at T1 | 28 participants |
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).
Time frame: enrollment (T0) and one month follow-up (T1)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Change in Patient Activation | enrollment (T0) | 64.3 score on a scale |
| Intervention | Change in Patient Activation | one month follow-up (T1) | 67.8 score on a scale |
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).
Time frame: one month follow-up (T1)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | System Usage Data | Total number of visits: 1-2 | 12 Participants |
| Intervention | System Usage Data | Total number of visits: 3-4 | 27 Participants |
| Intervention | System Usage Data | Total number of visits: 5-6 | 12 Participants |
| Intervention | System Usage Data | Total number of visits: 7+ | 9 Participants |
| Intervention | System Usage Data | Total minutes spent: <5 minutes | 4 Participants |
| Intervention | System Usage Data | Total minutes spent: 5-9 minutes | 7 Participants |
| Intervention | System Usage Data | Total minutes spent: 10-14 minutes | 19 Participants |
| Intervention | System Usage Data | Total minutes spent: 15+ minutes | 30 Participants |
| Intervention | System Usage Data | Used literacy sensitive education links | 51 Participants |
| Intervention | System Usage Data | Used secure messaging | 10 Participants |
| Intervention | System Usage Data | Used diabetes online community | 16 Participants |
| Intervention | System Usage Data | Used info icon with explanation of health measure | 49 Participants |