Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Patient Activation, Patient Web Portals, Health Information Technology
Brief summary
The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care, to evaluate its effect on patient activation and secondary cognitive, behavioral, and clinical outcomes.
Detailed description
300 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 150 will be assigned to receive access to the intervention (My Diabetes Care) embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 150 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt without the My Diabetes Care. Patients will be invited by mail (or email) to be screened for enrollment in the study. Eligible and interested patients will be emailed a link to a secure study website where they will complete a web consent form. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being randomized to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month and 6-month follow-ups to assess outcomes. In addition, system usage will be collected.
Interventions
The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive 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 * Reliable access to a computer (desktop or laptop) with internet capabilities * Active VUMC patient web portal (known as My Health At Vanderbilt) account
Exclusion criteria
* Residing in a long term care facility * Medical condition that affects my memory or ability to think. * Severe visual impairment * Currently participating in another diabetes-related research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Activation at 6 Months | Baseline to 6-month follow-up | The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. 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). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization. |
| Change in Patient Activation at 3 Months | Baseline to 3-month follow-up | The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. 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). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Knowledge | Baseline, 3-month follow up, 6-month follow-up | The Short Diabetes Knowledge Instrument (SDKI) is a valid measure of diabetes knowledge with an emphasis on controlling blood glucose through diet, recognizing symptoms of abnormal blood glucose, and using healthy eating to prevent complications. It also includes items on foot care and the importance of physical activity for preventing cardiovascular complications. The SDKI is a uni-dimensional, 13-item scale with scores ranging from 0 to 13 (number of items answered correctly). SDKI demonstrated good internal consistency reliability (Cronbach's alpha 0.73) in a multi-ethnic sample of older adults suggesting the instrument can be used to measure diabetes knowledge in diverse populations (Quandt et al. Diabetes Educator, 2014). |
| Change in Diabetes Self-Care (General Diet Adherence) | Baseline, 3-month follow up, 6-month follow-up | The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess general diet adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes How often did you follow your recommended diet over the last 7 days? All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005). |
| Change in Diabetes Self-Care (Specific Diet) | Baseline, 3-month follow up, 6-month follow-up | The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The specific diet subscale is used to assess intake of specific foods. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes How often did you follow your recommended diet over the last 7 days? All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005). |
| Change in Diabetes Self-Care (Exercise Adherence) | Baseline, 3-month follow up, 6-month follow-up | The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The exercise subscale is used to assess exercise adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes How often did you follow your recommended diet over the last 7 days? All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005). |
| Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) | Baseline, 3-month follow up, 6-month follow-up | The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess self-monitoring of blood glucose adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes How often did you follow your recommended diet over the last 7 days? All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005). |
| Change in Diabetes Self-Care (Diabetes Medication Adherence) | Baseline, 3-month follow up, 6-month follow-up | The Adherence to Refills and Medications Scale-Diabetes (ARMS-D) is a reliable and valid measure of diabetes medication adherence. The 11-item ARMS-D has good internal consistency reliability (α=0.86). Responses range from 1=none of the time to 4=all of the time, and are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence. |
| Change in Diabetes Distress | Baseline, 3-month follow up, 6-month follow-up | The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The five-item, uni-dimensional scale has scores that range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. The PAID-5 has excellent excellent internal consistency reliability (Cronbach's alpha 0.86) and is associated with measures of depression and hemoglobin A1c. |
| System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) | 6-month follow-up | Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality |
| Change in Blood Pressure Control | Baseline to 6-month follow-up | Participants' most recent blood pressure measurement will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3) and will be used to calculate the participants' mean arterial pressure (MAP) using the following formula: MAP = diastolic pressure + 1/3(systolic pressure - diastolic pressure). |
| Change in Flu Vaccination Status for 2019-20 Flu Season | Baseline, 3-month follow up | The participants' influenza vaccination status (vaccinated vs unvaccinated) for the 2019-20 Flu Season will be abstracted from participants' electronic medical record at enrollment (T0), 3 month follow-up (T1). |
| Change in Low Density Lipoprotein | Baseline to 6-month follow-up | Participants' most recent low density lipoprotein measurement will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3). |
| Satisfaction/Usability of My Health at Vanderbilt (for Control Group) | Baseline, 3-month follow up, 6-month follow-up | The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). 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). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91). |
| Satisfaction/Usability of My Diabetes Care (for Intervention Group) | 3-month follow up, 6-month follow-up | The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). 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). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91). |
| System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) | 6-month follow-up | Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality |
| System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | 6-month follow-up | Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality |
| Change in Blood Glucose Control | Baseline to 6-month follow-up | Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3). |
| Change in Diabetes Self-Efficacy | Baseline, 3-month follow up, 6-month follow-up | The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is 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. PDSMS has excellent internal consistency reliability (Cronbach's alpha of 0.83). PDSMS scores were associated with observed percentage of low blood sugars (r = .21), BMI (r = -.22), percentage of high blood sugars (r = -.36), average blood glucose (r = -.27), and A1C (r = -.25). Thus, the PDSMS appears to be validly associated with important self-management behaviors as well as with indicators of health status and diabetes control. |
Countries
United States
Participant flow
Pre-assignment details
17 participants were administratively withdrawn from the study before assignment to groups because they did not complete the baseline study questionnaire (needed prior to randomization). This included 13 patients that could not be reached after enrollment and 4 patients that were reached but did not return the baseline questionnaire. 270 patients completed the baseline study questionnaire and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.
My Diabetes Care: The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability. | 135 |
| Control Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care). | 135 |
| Total | 270 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 58 Participants | 118 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 152 Participants | 75 Participants |
| Diabetes Duration | 12 years | 12 years | 12 years |
| Education College graduate (bachelor's degree) | 35 Participants | 70 Participants | 35 Participants |
| Education Graduate degree | 38 Participants | 73 Participants | 35 Participants |
| Education High school graduate or GED | 10 Participants | 24 Participants | 14 Participants |
| Education Some college or technical school | 41 Participants | 77 Participants | 36 Participants |
| Education Some graduate work/school | 10 Participants | 21 Participants | 11 Participants |
| Education Some high school | 0 Participants | 3 Participants | 3 Participants |
| Education Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Employment Disabled, not able to work | 7 Participants | 18 Participants | 11 Participants |
| Employment Homemaker | 1 Participants | 2 Participants | 1 Participants |
| Employment In school | 0 Participants | 1 Participants | 1 Participants |
| Employment Retired | 57 Participants | 106 Participants | 49 Participants |
| Employment Something else | 4 Participants | 8 Participants | 4 Participants |
| Employment Unemployed or laid off and looking for work | 4 Participants | 8 Participants | 4 Participants |
| Employment Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Employment Working full-time, >=35 hours/week | 54 Participants | 111 Participants | 57 Participants |
| Employment Working part-time, <35 hours/week | 7 Participants | 14 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 129 Participants | 263 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Health Literacy Adequate | 91 Participants | 178 Participants | 87 Participants |
| Health Literacy Limited | 43 Participants | 90 Participants | 47 Participants |
| Health Literacy Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Insurance Governmental Plan No | 132 Participants | 261 Participants | 129 Participants |
| Insurance Governmental Plan Yes | 3 Participants | 9 Participants | 6 Participants |
| Insurance Group Plan No | 64 Participants | 131 Participants | 67 Participants |
| Insurance Group Plan Yes | 71 Participants | 139 Participants | 68 Participants |
| Insurance Individual Plan No | 126 Participants | 250 Participants | 124 Participants |
| Insurance Individual Plan Yes | 9 Participants | 20 Participants | 11 Participants |
| Insurance Medicaid No | 134 Participants | 265 Participants | 131 Participants |
| Insurance Medicaid Yes | 1 Participants | 5 Participants | 4 Participants |
| Insurance Medicare No | 83 Participants | 161 Participants | 78 Participants |
| Insurance Medicare Yes | 52 Participants | 109 Participants | 57 Participants |
| Insurance Uninsured No | 134 Participants | 267 Participants | 133 Participants |
| Insurance Uninsured Yes | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 36 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 107 Participants | 218 Participants | 111 Participants |
| Region of Enrollment United States | 135 participants | 270 participants | 135 participants |
| Sex/Gender, Customized Female | 49 Participants | 119 Participants | 70 Participants |
| Sex/Gender, Customized Male | 83 Participants | 146 Participants | 63 Participants |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 135 | 0 / 135 |
| other Total, other adverse events | 0 / 135 | 0 / 135 |
| serious Total, serious adverse events | 0 / 135 | 0 / 135 |
Outcome results
Change in Patient Activation at 3 Months
The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. 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). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization.
Time frame: Baseline to 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Patient Activation at 3 Months | 3.1 units on a scale | Standard Deviation 17.2 |
| Control | Change in Patient Activation at 3 Months | 3.3 units on a scale | Standard Deviation 15.6 |
Change in Patient Activation at 6 Months
The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. 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). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization.
Time frame: Baseline to 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Patient Activation at 6 Months | 4.3 units on a scale | Standard Deviation 16.8 |
| Control | Change in Patient Activation at 6 Months | 2.7 units on a scale | Standard Deviation 17.2 |
Change in Blood Glucose Control
Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3).
Time frame: Baseline to 6-month follow-up
Population: If date of the most recent hemoglobin A1c abstracted from the participant's electronic health record at 6 month follow-up was less than 90 or greater than 365 days from the date of the most recent hemoglobin A1c abstracted from the participant's electronic health record at baseline, then the participant was not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Blood Glucose Control | 0.1 percentage of glycated hemoglobin | Standard Deviation 1.2 |
| Control | Change in Blood Glucose Control | 0.1 percentage of glycated hemoglobin | Standard Deviation 0.8 |
Change in Blood Pressure Control
Participants' most recent blood pressure measurement will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3) and will be used to calculate the participants' mean arterial pressure (MAP) using the following formula: MAP = diastolic pressure + 1/3(systolic pressure - diastolic pressure).
Time frame: Baseline to 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Blood Pressure Control | -0.2 mmHg | Standard Deviation 6.9 |
| Control | Change in Blood Pressure Control | -0.2 mmHg | Standard Deviation 7.5 |
Change in Diabetes Distress
The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The five-item, uni-dimensional scale has scores that range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. The PAID-5 has excellent excellent internal consistency reliability (Cronbach's alpha 0.86) and is associated with measures of depression and hemoglobin A1c.
Time frame: Baseline, 3-month follow up, 6-month follow-up
Population: Participants with missing responses to items on the Problem Areas in Diabetes Scale (PAID-5) scale were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diabetes Distress | Change at 3 months | -0.2 units on a scale | Standard Deviation 2.8 |
| Intervention | Change in Diabetes Distress | Change at 6 months | -0.4 units on a scale | Standard Deviation 3.4 |
| Control | Change in Diabetes Distress | Change at 3 months | -0.2 units on a scale | Standard Deviation 3.4 |
| Control | Change in Diabetes Distress | Change at 6 months | -0.2 units on a scale | Standard Deviation 2.8 |
Change in Diabetes Knowledge
The Short Diabetes Knowledge Instrument (SDKI) is a valid measure of diabetes knowledge with an emphasis on controlling blood glucose through diet, recognizing symptoms of abnormal blood glucose, and using healthy eating to prevent complications. It also includes items on foot care and the importance of physical activity for preventing cardiovascular complications. The SDKI is a uni-dimensional, 13-item scale with scores ranging from 0 to 13 (number of items answered correctly). SDKI demonstrated good internal consistency reliability (Cronbach's alpha 0.73) in a multi-ethnic sample of older adults suggesting the instrument can be used to measure diabetes knowledge in diverse populations (Quandt et al. Diabetes Educator, 2014).
Time frame: Baseline, 3-month follow up, 6-month follow-up
Population: Participants with missing responses to items on the Short Diabetes Knowledge Instrument (SDKI) were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diabetes Knowledge | Change at 3 months | 0.7 units on a scale | Standard Deviation 10.3 |
| Intervention | Change in Diabetes Knowledge | Change at 6 months | 2.0 units on a scale | Standard Deviation 11 |
| Control | Change in Diabetes Knowledge | Change at 3 months | -0.1 units on a scale | Standard Deviation 10.2 |
| Control | Change in Diabetes Knowledge | Change at 6 months | 1.3 units on a scale | Standard Deviation 10.8 |
Change in Diabetes Self-Care (Diabetes Medication Adherence)
The Adherence to Refills and Medications Scale-Diabetes (ARMS-D) is a reliable and valid measure of diabetes medication adherence. The 11-item ARMS-D has good internal consistency reliability (α=0.86). Responses range from 1=none of the time to 4=all of the time, and are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence.
Time frame: Baseline, 3-month follow up, 6-month follow-up
Population: Participants with missing responses to items on the Adherence to Refills and Medications Scale-Diabetes (ARMS-D) scale were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diabetes Self-Care (Diabetes Medication Adherence) | Change at 3 months | -0.3 units on a scale | Standard Deviation 2 |
| Intervention | Change in Diabetes Self-Care (Diabetes Medication Adherence) | Change at 6 months | -0.3 units on a scale | Standard Deviation 2.9 |
| Control | Change in Diabetes Self-Care (Diabetes Medication Adherence) | Change at 3 months | 0.2 units on a scale | Standard Deviation 1.8 |
| Control | Change in Diabetes Self-Care (Diabetes Medication Adherence) | Change at 6 months | -0.1 units on a scale | Standard Deviation 1.8 |
Change in Diabetes Self-Care (Exercise Adherence)
The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The exercise subscale is used to assess exercise adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes How often did you follow your recommended diet over the last 7 days? All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).
Time frame: Baseline, 3-month follow up, 6-month follow-up
Population: Participants with missing responses to items on the 'exercise' subscale of the Summary of Diabetes Self-Care Activity (SDSCA) were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diabetes Self-Care (Exercise Adherence) | Change at 3 months | 0.2 units on a scale | Standard Deviation 1.6 |
| Intervention | Change in Diabetes Self-Care (Exercise Adherence) | Change at 6 months | 0 units on a scale | Standard Deviation 1.6 |
| Control | Change in Diabetes Self-Care (Exercise Adherence) | Change at 3 months | -0.1 units on a scale | Standard Deviation 1.6 |
| Control | Change in Diabetes Self-Care (Exercise Adherence) | Change at 6 months | 0.1 units on a scale | Standard Deviation 1.7 |
Change in Diabetes Self-Care (General Diet Adherence)
The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess general diet adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes How often did you follow your recommended diet over the last 7 days? All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).
Time frame: Baseline, 3-month follow up, 6-month follow-up
Population: Participants with missing responses to items on the 'general diet' subscale of the Summary of Diabetes Self-Care Activity (SDSCA) were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diabetes Self-Care (General Diet Adherence) | Change at 3 months | 0.3 units on a scale | Standard Deviation 1.6 |
| Intervention | Change in Diabetes Self-Care (General Diet Adherence) | Change at 6 months | 0.5 units on a scale | Standard Deviation 1.5 |
| Control | Change in Diabetes Self-Care (General Diet Adherence) | Change at 3 months | 0.1 units on a scale | Standard Deviation 1.5 |
| Control | Change in Diabetes Self-Care (General Diet Adherence) | Change at 6 months | 0.1 units on a scale | Standard Deviation 1.6 |
Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)
The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess self-monitoring of blood glucose adherence. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes How often did you follow your recommended diet over the last 7 days? All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).
Time frame: Baseline, 3-month follow up, 6-month follow-up
Population: The blood-glucose testing subscale was administered only to patients that reported testing their blood sugar at home. Participants with missing responses to items on the 'blood-glucose testing' subscale of the Summary of Diabetes Self-Care Activity (SDSCA) were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) | Change at 3 months | 0.3 units on a scale | Standard Deviation 2 |
| Intervention | Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) | Change at 6 months | 0.3 units on a scale | Standard Deviation 2.1 |
| Control | Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) | Change at 3 months | 0.1 units on a scale | Standard Deviation 1.7 |
| Control | Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) | Change at 6 months | 0.1 units on a scale | Standard Deviation 1.6 |
Change in Diabetes Self-Care (Specific Diet)
The Summary of Diabetes Self-Care Activity (SDSCA), developed by Toobert and Glasgow (1994), is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The specific diet subscale is used to assess intake of specific foods. The instrument is based on the self-reported frequency of completing recommended activities during the past 7 days. An example item includes How often did you follow your recommended diet over the last 7 days? All responses are converted to percentages. Higher percentages represent better self-care on each subscale. The SDSCA has been used in a number of settings and studies and has been recommended for a standardized evaluation of quality improvement interventions in T2DM in Canada (Majumdar et al., 2005).
Time frame: Baseline, 3-month follow up, 6-month follow-up
Population: Participants with missing responses to items on the 'specific diet' subscale of the Summary of Diabetes Self-Care Activity (SDSCA) were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diabetes Self-Care (Specific Diet) | Change at 3 months | 0.2 units on a scale | Standard Deviation 1.6 |
| Intervention | Change in Diabetes Self-Care (Specific Diet) | Change at 6 months | 0.3 units on a scale | Standard Deviation 1.3 |
| Control | Change in Diabetes Self-Care (Specific Diet) | Change at 3 months | 0 units on a scale | Standard Deviation 1.3 |
| Control | Change in Diabetes Self-Care (Specific Diet) | Change at 6 months | -0.1 units on a scale | Standard Deviation 1.4 |
Change in Diabetes Self-Efficacy
The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is 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. PDSMS has excellent internal consistency reliability (Cronbach's alpha of 0.83). PDSMS scores were associated with observed percentage of low blood sugars (r = .21), BMI (r = -.22), percentage of high blood sugars (r = -.36), average blood glucose (r = -.27), and A1C (r = -.25). Thus, the PDSMS appears to be validly associated with important self-management behaviors as well as with indicators of health status and diabetes control.
Time frame: Baseline, 3-month follow up, 6-month follow-up
Population: Participants with missing responses to items on the Perceived Diabetes Self-Management Scale (PDSMS) were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diabetes Self-Efficacy | Change at 3 months | 1.0 units on a scale | Standard Deviation 4 |
| Intervention | Change in Diabetes Self-Efficacy | Change at 6 months | 0.7 units on a scale | Standard Deviation 4.9 |
| Control | Change in Diabetes Self-Efficacy | Change at 3 months | 0.3 units on a scale | Standard Deviation 4.6 |
| Control | Change in Diabetes Self-Efficacy | Change at 6 months | 0.8 units on a scale | Standard Deviation 5 |
Change in Flu Vaccination Status for 2019-20 Flu Season
The participants' influenza vaccination status (vaccinated vs unvaccinated) for the 2019-20 Flu Season will be abstracted from participants' electronic medical record at enrollment (T0), 3 month follow-up (T1).
Time frame: Baseline, 3-month follow up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Change in Flu Vaccination Status for 2019-20 Flu Season | Baseline | Unvaccinated | 42 Participants |
| Intervention | Change in Flu Vaccination Status for 2019-20 Flu Season | Baseline | Vaccinated | 93 Participants |
| Intervention | Change in Flu Vaccination Status for 2019-20 Flu Season | 3 month follow-up | Unvaccinated | 40 Participants |
| Intervention | Change in Flu Vaccination Status for 2019-20 Flu Season | 3 month follow-up | Vaccinated | 95 Participants |
| Control | Change in Flu Vaccination Status for 2019-20 Flu Season | 3 month follow-up | Vaccinated | 102 Participants |
| Control | Change in Flu Vaccination Status for 2019-20 Flu Season | Baseline | Unvaccinated | 38 Participants |
| Control | Change in Flu Vaccination Status for 2019-20 Flu Season | 3 month follow-up | Unvaccinated | 33 Participants |
| Control | Change in Flu Vaccination Status for 2019-20 Flu Season | Baseline | Vaccinated | 97 Participants |
Change in Low Density Lipoprotein
Participants' most recent low density lipoprotein measurement will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3).
Time frame: Baseline to 6-month follow-up
Population: If date of the most recent low density lipoprotein (LDL) abstracted from the participant's electronic health record at 6 month follow-up was less than 90 or greater than 365 days from the date of the most recent LDL abstracted from the participant's electronic health record at baseline, then the participant was not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Low Density Lipoprotein | -3.0 mg/dL | Standard Deviation 22.7 |
| Control | Change in Low Density Lipoprotein | -3.8 mg/dL | Standard Deviation 36.1 |
Satisfaction/Usability of My Diabetes Care (for Intervention Group)
The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). 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). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).
Time frame: 3-month follow up, 6-month follow-up
Population: Participants with missing responses to items on the System Usability Scale (SUS) were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Satisfaction/Usability of My Diabetes Care (for Intervention Group) | 3 month follow-up | 73.7 score on a scale | Standard Deviation 14.3 |
| Intervention | Satisfaction/Usability of My Diabetes Care (for Intervention Group) | 6 month follow-up | 71.7 score on a scale | Standard Deviation 15.1 |
Satisfaction/Usability of My Health at Vanderbilt (for Control Group)
The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). 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). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).
Time frame: Baseline, 3-month follow up, 6-month follow-up
Population: Participants with missing responses to items on the System Usability Scale (SUS) were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Satisfaction/Usability of My Health at Vanderbilt (for Control Group) | Baseline | 79.0 score on a scale | Standard Deviation 12.9 |
| Intervention | Satisfaction/Usability of My Health at Vanderbilt (for Control Group) | 3 month follow-up | 82.4 score on a scale | Standard Deviation 13.4 |
| Intervention | Satisfaction/Usability of My Health at Vanderbilt (for Control Group) | 6 month follow-up | 83.2 score on a scale | Standard Deviation 12.7 |
System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)
Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality
Time frame: 6-month follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) | 5 minutes or less | 22 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) | 6 to 10 minutes | 37 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) | 11 to 15 minutes | 21 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) | 16 to 20 minutes | 22 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) | More than 20 minutes | 15 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) | Unknown or Not Reported | 18 Participants |
System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)
Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality
Time frame: 6-month follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) | None | 12 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) | One to three | 60 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) | Four to six | 39 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) | Seven to nine | 9 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) | Ten or more | 9 Participants |
| Intervention | System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) | Unknown or Not Reported | 6 Participants |
System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)
Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality
Time frame: 6-month follow-up
Population: My Diabetes Care features used at least once by the participant. Rows are not mutually exclusive as participants can use more than one feature. Participants with no response to this questionnaire item were not analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Message your Doctor button | No | 98 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Links to information about diabetes | No | 67 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Links to information about diabetes | Yes | 62 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Message your Doctor button | Yes | 31 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Online Patient Support Community button | No | 119 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Online Patient Support Community button | Yes | 10 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Hover over text or icon for more information about your diabetes health data | No | 70 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Hover over text or icon for more information about your diabetes health data | Yes | 59 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Diabetes News Feeds (Diabetes Views or ADA Diabetes Blog) | No | 104 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | Diabetes News Feeds (Diabetes Views or ADA Diabetes Blog) | Yes | 25 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | None of the above | No | 99 Participants |
| Intervention | System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) | None of the above | Yes | 30 Participants |