Trial Outcomes & Findings for Evaluation of a Patient Portal Intervention for Diabetes: A Pilot Randomized Controlled Trial (NCT NCT03947333)

Last Updated: 2022-03-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

287 participants

Primary outcome timeframe

Baseline to 6-month follow-up

Results posted on

2022-03-31

Participant Flow

17 participants were administratively withdrawn from the study before assignment to groups because they did not complete the baseline study questionnaire (needed prior to randomization).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.

Participant milestones

Participant milestones
Measure	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.	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).
Overall Study STARTED	135	135
Overall Study COMPLETED	135	135
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=135 Participants 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.	Control n=135 Participants 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).	Total n=270 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	77 Participants n=5 Participants	75 Participants n=7 Participants	152 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants	60 Participants n=7 Participants	118 Participants n=5 Participants
Sex/Gender, Customized Female	49 Participants n=5 Participants	70 Participants n=7 Participants	119 Participants n=5 Participants
Sex/Gender, Customized Male	83 Participants n=5 Participants	63 Participants n=7 Participants	146 Participants n=5 Participants
Sex/Gender, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex/Gender, Customized Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	129 Participants n=5 Participants	134 Participants n=7 Participants	263 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	107 Participants n=5 Participants	111 Participants n=7 Participants	218 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	135 participants n=5 Participants	135 participants n=7 Participants	270 participants n=5 Participants
Education Some high school	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Education High school graduate or GED	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Education Some college or technical school	41 Participants n=5 Participants	36 Participants n=7 Participants	77 Participants n=5 Participants
Education College graduate (bachelor's degree)	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Education Some graduate work/school	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Education Graduate degree	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Education Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Employment Working full-time, >=35 hours/week	54 Participants n=5 Participants	57 Participants n=7 Participants	111 Participants n=5 Participants
Employment Working part-time, <35 hours/week	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Employment Unemployed or laid off and looking for work	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Employment Homemaker	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Employment In school	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Employment Retired	57 Participants n=5 Participants	49 Participants n=7 Participants	106 Participants n=5 Participants
Employment Disabled, not able to work	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Employment Something else	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Employment Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Insurance Individual Plan · No	126 Participants n=5 Participants	124 Participants n=7 Participants	250 Participants n=5 Participants
Insurance Individual Plan · Yes	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Insurance Group Plan · No	64 Participants n=5 Participants	67 Participants n=7 Participants	131 Participants n=5 Participants
Insurance Group Plan · Yes	71 Participants n=5 Participants	68 Participants n=7 Participants	139 Participants n=5 Participants
Insurance Governmental Plan · No	132 Participants n=5 Participants	129 Participants n=7 Participants	261 Participants n=5 Participants
Insurance Governmental Plan · Yes	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Insurance Medicaid · No	134 Participants n=5 Participants	131 Participants n=7 Participants	265 Participants n=5 Participants
Insurance Medicaid · Yes	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Insurance Medicare · No	83 Participants n=5 Participants	78 Participants n=7 Participants	161 Participants n=5 Participants
Insurance Medicare · Yes	52 Participants n=5 Participants	57 Participants n=7 Participants	109 Participants n=5 Participants
Insurance Uninsured · No	134 Participants n=5 Participants	133 Participants n=7 Participants	267 Participants n=5 Participants
Insurance Uninsured · Yes	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Health Literacy Adequate	91 Participants n=5 Participants	87 Participants n=7 Participants	178 Participants n=5 Participants
Health Literacy Limited	43 Participants n=5 Participants	47 Participants n=7 Participants	90 Participants n=5 Participants
Health Literacy Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Diabetes Duration	12 years n=5 Participants	12 years n=7 Participants	12 years n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6-month follow-up

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	Control n=135 Participants 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).
Change in Patient Activation at 6 Months	4.3 units on a scale Standard Deviation 16.8	2.7 units on a scale Standard Deviation 17.2

PRIMARY outcome

Timeframe: Baseline to 3-month follow-up

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	Control n=135 Participants 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).
Change in Patient Activation at 3 Months	3.1 units on a scale Standard Deviation 17.2	3.3 units on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=134 Participants 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.	Control n=135 Participants 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).
Change in Diabetes Self-Efficacy Change at 3 months	1.0 units on a scale Standard Deviation 4.0	0.3 units on a scale Standard Deviation 4.6
Change in Diabetes Self-Efficacy Change at 6 months	0.7 units on a scale Standard Deviation 4.9	0.8 units on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Intervention n=131 Participants 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.	Control n=134 Participants 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).
Change in Diabetes Knowledge Change at 3 months	0.7 units on a scale Standard Deviation 10.3	-0.1 units on a scale Standard Deviation 10.2
Change in Diabetes Knowledge Change at 6 months	2.0 units on a scale Standard Deviation 11.0	1.3 units on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	Control n=134 Participants 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).
Change in Diabetes Self-Care (General Diet Adherence) Change at 3 months	0.3 units on a scale Standard Deviation 1.6	0.1 units on a scale Standard Deviation 1.5
Change in Diabetes Self-Care (General Diet Adherence) Change at 6 months	0.5 units on a scale Standard Deviation 1.5	0.1 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	Control n=134 Participants 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).
Change in Diabetes Self-Care (Specific Diet) Change at 6 months	0.3 units on a scale Standard Deviation 1.3	-0.1 units on a scale Standard Deviation 1.4
Change in Diabetes Self-Care (Specific Diet) Change at 3 months	0.2 units on a scale Standard Deviation 1.6	0 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	Control n=132 Participants 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).
Change in Diabetes Self-Care (Exercise Adherence) Change at 3 months	0.2 units on a scale Standard Deviation 1.6	-0.1 units on a scale Standard Deviation 1.6
Change in Diabetes Self-Care (Exercise Adherence) Change at 6 months	0 units on a scale Standard Deviation 1.6	0.1 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Intervention n=118 Participants 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.	Control n=114 Participants 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).
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	0.1 units on a scale Standard Deviation 1.6
Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) Change at 3 months	0.3 units on a scale Standard Deviation 2.0	0.1 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=132 Participants 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.	Control n=133 Participants 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).
Change in Diabetes Self-Care (Diabetes Medication Adherence) Change at 3 months	-0.3 units on a scale Standard Deviation 2.0	0.2 units on a scale Standard Deviation 1.8
Change in Diabetes Self-Care (Diabetes Medication Adherence) Change at 6 months	-0.3 units on a scale Standard Deviation 2.9	-0.1 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=134 Participants 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.	Control n=133 Participants 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).
Change in Diabetes Distress Change at 3 months	-0.2 units on a scale Standard Deviation 2.8	-0.2 units on a scale Standard Deviation 3.4
Change in Diabetes Distress Change at 6 months	-0.4 units on a scale Standard Deviation 3.4	-0.2 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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.

Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3).

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	Control n=132 Participants 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).
Change in Blood Glucose Control	0.1 percentage of glycated hemoglobin Standard Deviation 1.2	0.1 percentage of glycated hemoglobin Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	Control n=135 Participants 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).
Change in Blood Pressure Control	-0.2 mmHg Standard Deviation 6.9	-0.2 mmHg Standard Deviation 7.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	Control n=135 Participants 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).
Change in Flu Vaccination Status for 2019-20 Flu Season Baseline · Vaccinated	93 Participants	97 Participants
Change in Flu Vaccination Status for 2019-20 Flu Season 3 month follow-up · Unvaccinated	40 Participants	33 Participants
Change in Flu Vaccination Status for 2019-20 Flu Season Baseline · Unvaccinated	42 Participants	38 Participants
Change in Flu Vaccination Status for 2019-20 Flu Season 3 month follow-up · Vaccinated	95 Participants	102 Participants

SECONDARY outcome

Timeframe: 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.

Participants' most recent low density lipoprotein measurement will be abstracted from participants' electronic medical record at enrollment (T0) and 6 month follow-up (T3).

Outcome measures

Outcome measures
Measure	Intervention n=131 Participants 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.	Control n=125 Participants 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).
Change in Low Density Lipoprotein	-3.0 mg/dL Standard Deviation 22.7	-3.8 mg/dL Standard Deviation 36.1

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Intervention n=131 Participants 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.	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).
Satisfaction/Usability of My Health at Vanderbilt (for Control Group) Baseline	79.0 score on a scale Standard Deviation 12.9	—
Satisfaction/Usability of My Health at Vanderbilt (for Control Group) 3 month follow-up	82.4 score on a scale Standard Deviation 13.4	—
Satisfaction/Usability of My Health at Vanderbilt (for Control Group) 6 month follow-up	83.2 score on a scale Standard Deviation 12.7	—

SECONDARY outcome

Timeframe: 3-month follow up, 6-month follow-up

Population: Participants with missing responses to items on the System Usability Scale (SUS) were not analyzed.

Outcome measures

Outcome measures
Measure	Intervention n=134 Participants 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.	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).
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 Diabetes Care (for Intervention Group) 3 month follow-up	73.7 score on a scale Standard Deviation 14.3	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	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).
System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) None	12 Participants	—
System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) One to three	60 Participants	—
System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) Four to six	39 Participants	—
System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) Seven to nine	9 Participants	—
System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) Ten or more	9 Participants	—
System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) Unknown or Not Reported	6 Participants	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants 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.	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).
System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) 11 to 15 minutes	21 Participants	—
System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) 16 to 20 minutes	22 Participants	—
System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) More than 20 minutes	15 Participants	—
System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) 5 minutes or less	22 Participants	—
System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) 6 to 10 minutes	37 Participants	—
System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) Unknown or Not Reported	18 Participants	—

SECONDARY outcome

Timeframe: 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.

Self-reported system usage will include: participants' total number of visits, total duration of visits, and utilization of embedded features and functionality

Outcome measures

Outcome measures
Measure	Intervention n=129 Participants 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.	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).
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	—
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	—
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	—
System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) None of the above · No	99 Participants	—
System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) None of the above · Yes	30 Participants	—
System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) Links to information about diabetes · No	67 Participants	—
System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) Links to information about diabetes · Yes	62 Participants	—
System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) Message your Doctor button · No	98 Participants	—
System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) Message your Doctor button · Yes	31 Participants	—
System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) Online Patient Support Community button · No	119 Participants	—
System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) Online Patient Support Community button · Yes	10 Participants	—
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	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Martinez, MD

Vanderbilt University Medical Center

Phone: (615) 936-1010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place