Skip to content

Evaluation of a Patient Portal Intervention for Diabetes: A Pilot Randomized Controlled Trial

Evaluation of a Patient Portal Intervention for Diabetes: A Two-arm, Parallel-Design, Pilot Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03947333
Enrollment
287
Registered
2019-05-13
Start date
2020-03-09
Completion date
2021-01-11
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Change in Patient Activation at 6 MonthsBaseline to 6-month follow-upThe 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 MonthsBaseline to 3-month follow-upThe 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

MeasureTime frameDescription
Change in Diabetes KnowledgeBaseline, 3-month follow up, 6-month follow-upThe 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-upThe 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-upThe 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-upThe 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-upThe 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-upThe 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 DistressBaseline, 3-month follow up, 6-month follow-upThe 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-upSelf-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 ControlBaseline to 6-month follow-upParticipants' 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 SeasonBaseline, 3-month follow upThe 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 LipoproteinBaseline to 6-month follow-upParticipants' 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-upThe 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-upThe 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-upSelf-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-upSelf-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 ControlBaseline to 6-month follow-upParticipants' 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-EfficacyBaseline, 3-month follow up, 6-month follow-upThe 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

ArmCount
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
Total270

Baseline characteristics

CharacteristicInterventionTotalControl
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
58 Participants118 Participants60 Participants
Age, Categorical
Between 18 and 65 years
77 Participants152 Participants75 Participants
Diabetes Duration12 years12 years12 years
Education
College graduate (bachelor's degree)
35 Participants70 Participants35 Participants
Education
Graduate degree
38 Participants73 Participants35 Participants
Education
High school graduate or GED
10 Participants24 Participants14 Participants
Education
Some college or technical school
41 Participants77 Participants36 Participants
Education
Some graduate work/school
10 Participants21 Participants11 Participants
Education
Some high school
0 Participants3 Participants3 Participants
Education
Unknown or Not Reported
1 Participants2 Participants1 Participants
Employment
Disabled, not able to work
7 Participants18 Participants11 Participants
Employment
Homemaker
1 Participants2 Participants1 Participants
Employment
In school
0 Participants1 Participants1 Participants
Employment
Retired
57 Participants106 Participants49 Participants
Employment
Something else
4 Participants8 Participants4 Participants
Employment
Unemployed or laid off and looking for work
4 Participants8 Participants4 Participants
Employment
Unknown or Not Reported
1 Participants2 Participants1 Participants
Employment
Working full-time, >=35 hours/week
54 Participants111 Participants57 Participants
Employment
Working part-time, <35 hours/week
7 Participants14 Participants7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants5 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
129 Participants263 Participants134 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
Health Literacy
Adequate
91 Participants178 Participants87 Participants
Health Literacy
Limited
43 Participants90 Participants47 Participants
Health Literacy
Unknown or Not Reported
1 Participants2 Participants1 Participants
Insurance
Governmental Plan
No
132 Participants261 Participants129 Participants
Insurance
Governmental Plan
Yes
3 Participants9 Participants6 Participants
Insurance
Group Plan
No
64 Participants131 Participants67 Participants
Insurance
Group Plan
Yes
71 Participants139 Participants68 Participants
Insurance
Individual Plan
No
126 Participants250 Participants124 Participants
Insurance
Individual Plan
Yes
9 Participants20 Participants11 Participants
Insurance
Medicaid
No
134 Participants265 Participants131 Participants
Insurance
Medicaid
Yes
1 Participants5 Participants4 Participants
Insurance
Medicare
No
83 Participants161 Participants78 Participants
Insurance
Medicare
Yes
52 Participants109 Participants57 Participants
Insurance
Uninsured
No
134 Participants267 Participants133 Participants
Insurance
Uninsured
Yes
1 Participants3 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Black or African American
17 Participants36 Participants19 Participants
Race (NIH/OMB)
More than one race
5 Participants7 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
White
107 Participants218 Participants111 Participants
Region of Enrollment
United States
135 participants270 participants135 participants
Sex/Gender, Customized
Female
49 Participants119 Participants70 Participants
Sex/Gender, Customized
Male
83 Participants146 Participants63 Participants
Sex/Gender, Customized
Other
1 Participants1 Participants0 Participants
Sex/Gender, Customized
Unknown or Not Reported
2 Participants4 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1350 / 135
other
Total, other adverse events
0 / 1350 / 135
serious
Total, serious adverse events
0 / 1350 / 135

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Patient Activation at 3 Months3.1 units on a scaleStandard Deviation 17.2
ControlChange in Patient Activation at 3 Months3.3 units on a scaleStandard Deviation 15.6
p-value: 0.532t-test, 1 sided
Primary

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Patient Activation at 6 Months4.3 units on a scaleStandard Deviation 16.8
ControlChange in Patient Activation at 6 Months2.7 units on a scaleStandard Deviation 17.2
p-value: 0.221t-test, 1 sided
Comparison: Mixed effects modelp-value: 0.55995% CI: [-1.99, 3.68]Mixed Models Analysis
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Blood Glucose Control0.1 percentage of glycated hemoglobinStandard Deviation 1.2
ControlChange in Blood Glucose Control0.1 percentage of glycated hemoglobinStandard Deviation 0.8
p-value: 0.654t-test, 1 sided
Secondary

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Blood Pressure Control-0.2 mmHgStandard Deviation 6.9
ControlChange in Blood Pressure Control-0.2 mmHgStandard Deviation 7.5
p-value: 0.485t-test, 1 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Diabetes DistressChange at 3 months-0.2 units on a scaleStandard Deviation 2.8
InterventionChange in Diabetes DistressChange at 6 months-0.4 units on a scaleStandard Deviation 3.4
ControlChange in Diabetes DistressChange at 3 months-0.2 units on a scaleStandard Deviation 3.4
ControlChange in Diabetes DistressChange at 6 months-0.2 units on a scaleStandard Deviation 2.8
Comparison: Change at 3 monthsp-value: 0.478t-test, 1 sided
Comparison: Change at 6 monthsp-value: 0.666t-test, 1 sided
Comparison: Mixed Effects Modelp-value: 0.60195% CI: [-0.713, 0.413]Mixed Models Analysis
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Diabetes KnowledgeChange at 3 months0.7 units on a scaleStandard Deviation 10.3
InterventionChange in Diabetes KnowledgeChange at 6 months2.0 units on a scaleStandard Deviation 11
ControlChange in Diabetes KnowledgeChange at 3 months-0.1 units on a scaleStandard Deviation 10.2
ControlChange in Diabetes KnowledgeChange at 6 months1.3 units on a scaleStandard Deviation 10.8
Comparison: Change at 3 monthsp-value: 0.27t-test, 1 sided
Comparison: Change at 6 monthsp-value: 0.299t-test, 1 sided
Comparison: Mixed effects modelp-value: 0.91795% CI: [-1.786, 1.986]Mixed Models Analysis
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Diabetes Self-Care (Diabetes Medication Adherence)Change at 3 months-0.3 units on a scaleStandard Deviation 2
InterventionChange in Diabetes Self-Care (Diabetes Medication Adherence)Change at 6 months-0.3 units on a scaleStandard Deviation 2.9
ControlChange in Diabetes Self-Care (Diabetes Medication Adherence)Change at 3 months0.2 units on a scaleStandard Deviation 1.8
ControlChange in Diabetes Self-Care (Diabetes Medication Adherence)Change at 6 months-0.1 units on a scaleStandard Deviation 1.8
Comparison: Change at 3 monthsp-value: 0.97t-test, 1 sided
Comparison: Change at 6 monthsp-value: 0.786t-test, 1 sided
Comparison: Mixed Effects Modelp-value: 0.6795% CI: [-0.493, 0.317]Mixed Models Analysis
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Diabetes Self-Care (Exercise Adherence)Change at 3 months0.2 units on a scaleStandard Deviation 1.6
InterventionChange in Diabetes Self-Care (Exercise Adherence)Change at 6 months0 units on a scaleStandard Deviation 1.6
ControlChange in Diabetes Self-Care (Exercise Adherence)Change at 3 months-0.1 units on a scaleStandard Deviation 1.6
ControlChange in Diabetes Self-Care (Exercise Adherence)Change at 6 months0.1 units on a scaleStandard Deviation 1.7
Comparison: Change at 3 monthsp-value: 0.188t-test, 1 sided
Comparison: Change at 6 monthsp-value: 0.749t-test, 1 sided
Comparison: Mixed Effects Modelp-value: 0.84795% CI: [-0.288, 0.351]Mixed Models Analysis
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Diabetes Self-Care (General Diet Adherence)Change at 3 months0.3 units on a scaleStandard Deviation 1.6
InterventionChange in Diabetes Self-Care (General Diet Adherence)Change at 6 months0.5 units on a scaleStandard Deviation 1.5
ControlChange in Diabetes Self-Care (General Diet Adherence)Change at 3 months0.1 units on a scaleStandard Deviation 1.5
ControlChange in Diabetes Self-Care (General Diet Adherence)Change at 6 months0.1 units on a scaleStandard Deviation 1.6
Comparison: Change at 3 monthsp-value: 0.093t-test, 1 sided
Comparison: Change at 6 monthsp-value: 0.034t-test, 1 sided
Comparison: Mixed Effects Modelp-value: 0.10395% CI: [-0.049, 0.533]Mixed Models Analysis
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)Change at 3 months0.3 units on a scaleStandard Deviation 2
InterventionChange in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)Change at 6 months0.3 units on a scaleStandard Deviation 2.1
ControlChange in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)Change at 3 months0.1 units on a scaleStandard Deviation 1.7
ControlChange in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)Change at 6 months0.1 units on a scaleStandard Deviation 1.6
Comparison: Change at 3 monthsp-value: 0.182t-test, 1 sided
Comparison: Change at 6 monthsp-value: 0.158t-test, 1 sided
Comparison: Mixed Effects Modelp-value: 0.61295% CI: [-0.305, 0.519]Mixed Models Analysis
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Diabetes Self-Care (Specific Diet)Change at 3 months0.2 units on a scaleStandard Deviation 1.6
InterventionChange in Diabetes Self-Care (Specific Diet)Change at 6 months0.3 units on a scaleStandard Deviation 1.3
ControlChange in Diabetes Self-Care (Specific Diet)Change at 3 months0 units on a scaleStandard Deviation 1.3
ControlChange in Diabetes Self-Care (Specific Diet)Change at 6 months-0.1 units on a scaleStandard Deviation 1.4
Comparison: Mixed Effects Modelp-value: 0.17895% CI: [-0.084, 0.451]Mixed Models Analysis
Comparison: Change at 3 monthsp-value: 0.116t-test, 1 sided
p-value: 0.009t-test, 1 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionChange in Diabetes Self-EfficacyChange at 3 months1.0 units on a scaleStandard Deviation 4
InterventionChange in Diabetes Self-EfficacyChange at 6 months0.7 units on a scaleStandard Deviation 4.9
ControlChange in Diabetes Self-EfficacyChange at 3 months0.3 units on a scaleStandard Deviation 4.6
ControlChange in Diabetes Self-EfficacyChange at 6 months0.8 units on a scaleStandard Deviation 5
Comparison: Change at 3 monthsp-value: 0.086t-test, 1 sided
Comparison: Change at 6 monthsp-value: 0.562t-test, 1 sided
Comparison: Mixed Effects Modelp-value: 0.45195% CI: [-0.557, 1.254]Mixed Models Analysis
Secondary

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

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionChange in Flu Vaccination Status for 2019-20 Flu SeasonBaselineUnvaccinated42 Participants
InterventionChange in Flu Vaccination Status for 2019-20 Flu SeasonBaselineVaccinated93 Participants
InterventionChange in Flu Vaccination Status for 2019-20 Flu Season3 month follow-upUnvaccinated40 Participants
InterventionChange in Flu Vaccination Status for 2019-20 Flu Season3 month follow-upVaccinated95 Participants
ControlChange in Flu Vaccination Status for 2019-20 Flu Season3 month follow-upVaccinated102 Participants
ControlChange in Flu Vaccination Status for 2019-20 Flu SeasonBaselineUnvaccinated38 Participants
ControlChange in Flu Vaccination Status for 2019-20 Flu Season3 month follow-upUnvaccinated33 Participants
ControlChange in Flu Vaccination Status for 2019-20 Flu SeasonBaselineVaccinated97 Participants
p-value: 0.48McNemar
p-value: 0.023McNemar
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Low Density Lipoprotein-3.0 mg/dLStandard Deviation 22.7
ControlChange in Low Density Lipoprotein-3.8 mg/dLStandard Deviation 36.1
p-value: 0.542t-test, 1 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionSatisfaction/Usability of My Diabetes Care (for Intervention Group)3 month follow-up73.7 score on a scaleStandard Deviation 14.3
InterventionSatisfaction/Usability of My Diabetes Care (for Intervention Group)6 month follow-up71.7 score on a scaleStandard Deviation 15.1
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionSatisfaction/Usability of My Health at Vanderbilt (for Control Group)Baseline79.0 score on a scaleStandard Deviation 12.9
InterventionSatisfaction/Usability of My Health at Vanderbilt (for Control Group)3 month follow-up82.4 score on a scaleStandard Deviation 13.4
InterventionSatisfaction/Usability of My Health at Vanderbilt (for Control Group)6 month follow-up83.2 score on a scaleStandard Deviation 12.7
Secondary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionSystem Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)5 minutes or less22 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)6 to 10 minutes37 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)11 to 15 minutes21 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)16 to 20 minutes22 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)More than 20 minutes15 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)Unknown or Not Reported18 Participants
Secondary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionSystem Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)None12 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)One to three60 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)Four to six39 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)Seven to nine9 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)Ten or more9 Participants
InterventionSystem Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)Unknown or Not Reported6 Participants
Secondary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)Message your Doctor buttonNo98 Participants
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)Links to information about diabetesNo67 Participants
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)Links to information about diabetesYes62 Participants
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)Message your Doctor buttonYes31 Participants
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)Online Patient Support Community buttonNo119 Participants
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)Online Patient Support Community buttonYes10 Participants
InterventionSystem 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 dataNo70 Participants
InterventionSystem 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 dataYes59 Participants
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)Diabetes News Feeds (Diabetes Views or ADA Diabetes Blog)No104 Participants
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)Diabetes News Feeds (Diabetes Views or ADA Diabetes Blog)Yes25 Participants
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)None of the aboveNo99 Participants
InterventionSystem Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)None of the aboveYes30 Participants

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026