Skip to content

My Diabetes Care Mobile: A Usability Study

The My Diabetes Care Patient Portal Intervention for Mobile Devices: A Usability Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04894916
Enrollment
64
Registered
2021-05-20
Start date
2021-06-12
Completion date
2021-08-27
Last updated
2022-11-10

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 Mellitus, Self-efficacy, Patient Web Portals

Brief summary

The purpose of this study is to conduct a prospective, longitudinal study on the My Diabetes Care mobile (MDC-m) intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.

Detailed description

Up to 65 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care mobile (MDC-m). My Diabetes Care mobile (MDC-m) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care information. Patients will be invited by mail to be screened for enrollment in the study. Interested patients will be able to complete an electronic consent form and enroll online via Research Electronic Data Capture (REDCap™) version 5.0.8. Study participants will complete questionnaires electronically via email using REDCap™ at two time points: baseline (T0) and one-month follow-up (T1). Participants will complete an baseline questionnaire (T0) including basic demographic questions, items about computer usage and internet access, and validated measures of health literacy and eHealth literacy. Each participant will have access to the MDC-m for 1 month.

Interventions

OTHERMy Diabetes Care Mobile (MDC-m)

My Diabetes Care (MDC) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care information.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
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 taking at least one medication for diabetes * Age 21 or over * Able to speak and read in English * Reliable access to a smartphone or tablet with internet access * 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 * Patients with unintelligible speech (e.g., dysarthria) * Currently participating in another diabetes-related research study

Design outcomes

Primary

MeasureTime frameDescription
UsabilityOne-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 DataOne-month follow-upSelf-reported usage of My Diabetes Care to include total number of participants who visited MDC-m during the study period and total number of participants with who used MDC-m for 10 minutes or more during the study period.
User ExperienceOne-month follow-upUnique study specific items to assess participants' perspectives on the usefulness of particular My Diabetes Care features and functionality.

Secondary

MeasureTime frameDescription
Change in Diabetes DistressBaseline to one-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.
Change in Diabetes AttitudesBaseline to one-month follow-upUnique study specific items to assess participants' attitudes toward social comparisons (2 items) and goal-based comparisons (2 items) regarding their diabetes health status. Each items is scored on a 5-point Likert scale from '1=strongly disagree' to '5=strongly agree'.
Change in Diabetes Readiness for ChangeBaseline to one-month follow-upFour-item assessment of stage of change based on the Transtheoretical Model (TTM) of behavior change. It includes questions one item each assessing the participants stage of change for: (1) physical activity, (2) medication management, (3) glucose self-monitoring, and (4) diet. There are five response options per item that categorize the participants' current TTM stage of change for the item: (a) Precontemplation, (b) Contemplation, (c) Preparation, (d) Action, and (e) Maintenance.
Change in Diabetes Self-Care (General Diet Adherence)Baseline to one-month follow-upThe Summary of Diabetes Self-Care Activity (SDSCA) 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 days completing recommended activities during the past 7 days. An example item includes How many of the last SEVEN DAYS have you followed a healthful eating plan? The general diet subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).
Change in Diabetes KnowledgeBaseline to one-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 (Exercise Adherence)Baseline to one-month follow-upThe Summary of Diabetes Self-Care Activity (SDSCA) 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 days completing recommended activities during the past 7 days. An example item includes On how many of the last SEVEN DAYS did you participate in at least 30 minutes of physical activity? The exercise subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).
Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)Baseline to one-month Follow-upThe Summary of Diabetes Self-Care Activity (SDSCA) 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 days completing recommended activities during the past 7 days. An example item includes On how many of the last SEVEN DAYS did you test your blood sugar? The blood-glucose testing subscale is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).
Change in Medication AdherenceBaseline to one-month follow-upThe Adherence to Refills and Medications Scale is a reliable and valid measure of medication adherence. The 12-item ARMS has good internal consistency reliability (α=0.81). 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 Self-Care (Specific Diet Adherence)Baseline to one-month follow-upThe Summary of Diabetes Self-Care Activity (SDSCA) 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 days completing recommended activities during the past 7 days. An example item includes How many of the last SEVEN DAYS have you followed a healthful eating plan? The general diet subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).
Change in Diabetes Self-EfficacyBaseline to one-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.
Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresBaseline to one-month follow-upUnique study specific items to assess participants' knowledge of measures of diabetes health status (i.e., Hemoglobin A1C, blood pressure, low-density lipoprotein, and flu vaccination status). Each multiple choice item has one correct answer and the unit of measure is the number of participants that correctly answered each item.

Countries

United States

Participant flow

Pre-assignment details

Of the 64 enrolled participants, 59 completed the baseline questionnaire and were with given access to the intervention (My Diabetes Care).

Participants by arm

ArmCount
My Diabetes Care Mobile (MDC-m)
Patients have access to a patient web portal embedded with the My Diabetes Care Mobile (MDC-m) intervention. My Diabetes Care Mobile (MDC-m): My Diabetes Care (MDC) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care information.
59
Total59

Baseline characteristics

CharacteristicMy Diabetes Care Mobile (MDC-m)
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
18 Participants
Age, Categorical
Between 18 and 65 years
41 Participants
Age, Continuous58.5 years
STANDARD_DEVIATION 11.2
Education
College graduate
16 Participants
Education
Graduate degree
18 Participants
Education
High school graduate or GED
5 Participants
Education
Some college or technical school
14 Participants
Education
Some graduate school/work
6 Participants
eHealth Literacy32.8 units on a scale
STANDARD_DEVIATION 5.1
Employment
Disabled, not able to work
7 Participants
Employment
Full time
23 Participants
Employment
Others
3 Participants
Employment
Part time
4 Participants
Employment
Retired
21 Participants
Employment
Unemployed/laid off, looking for work
1 Participants
Health Literacy
Adequate
51 Participants
Health Literacy
Limited
8 Participants
Race/Ethnicity, Customized
American Indian / Alaska Native
1 Participants
Race/Ethnicity, Customized
Asian
2 Participants
Race/Ethnicity, Customized
Black
21 Participants
Race/Ethnicity, Customized
More than one race
2 Participants
Race/Ethnicity, Customized
Other
1 Participants
Race/Ethnicity, Customized
White
32 Participants
Sex: Female, Male
Female
33 Participants
Sex: Female, Male
Male
26 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 59
other
Total, other adverse events
0 / 59
serious
Total, serious adverse events
0 / 59

Outcome results

Primary

System Usage Data

Self-reported usage of My Diabetes Care to include total number of participants who visited MDC-m during the study period and total number of participants with who used MDC-m for 10 minutes or more during the study period.

Time frame: One-month follow-up

Population: Number analyzed includes only participants that answered the survey items. One participant did not answer the items.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
My Diabetes Care Mobile (MDC-m)System Usage DataDid you use My Diabetes Care during the study period?Yes54 Participants
My Diabetes Care Mobile (MDC-m)System Usage DataDid you use My Diabetes Care during the study period?No4 Participants
My Diabetes Care Mobile (MDC-m)System Usage DataDid you use My Diabetes Care for 10 minutes or more?Yes47 Participants
My Diabetes Care Mobile (MDC-m)System Usage DataDid you use My Diabetes Care for 10 minutes or more?No11 Participants
Primary

Usability

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: One-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the System Usability Scale items on the post-questionnaire.

ArmMeasureValue (MEAN)Dispersion
My Diabetes Care Mobile (MDC-m)Usability81.9 score on a scaleStandard Deviation 15.4
Comparison: One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is equal to 71.p-value: <0.001t-test, 2 sided
Primary

User Experience

Unique study specific items to assess participants' perspectives on the usefulness of particular My Diabetes Care features and functionality.

Time frame: One-month follow-up

ArmMeasureGroupValue (NUMBER)
My Diabetes Care Mobile (MDC-m)User ExperienceQuestion Mark Icon - useful25 participants
My Diabetes Care Mobile (MDC-m)User ExperienceGoal, Caution, and Warning Ranges - useful40 participants
My Diabetes Care Mobile (MDC-m)User ExperienceGraphs showing trends in your diabetes health data over time - useful41 participants
My Diabetes Care Mobile (MDC-m)User ExperiencePatients Like Me Data - useful25 participants
My Diabetes Care Mobile (MDC-m)User ExperienceLiteracy level appropriate educational links about each diabetes health measure - useful24 participants
My Diabetes Care Mobile (MDC-m)User ExperienceMake a Change for the Better module - useful21 participants
My Diabetes Care Mobile (MDC-m)User ExperienceLiteracy level appropriate educational links with tips to improve your diabetes - useful22 participants
My Diabetes Care Mobile (MDC-m)User ExperienceDiabetes Online Community - useful8 participants
Secondary

Change in Diabetes Attitudes

Unique study specific items to assess participants' attitudes toward social comparisons (2 items) and goal-based comparisons (2 items) regarding their diabetes health status. Each items is scored on a 5-point Likert scale from '1=strongly disagree' to '5=strongly agree'.

Time frame: Baseline to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered the study specific diabetes attitudes item on both the pre- and post-questionnaire.

ArmMeasureGroupValue (NUMBER)
My Diabetes Care Mobile (MDC-m)Change in Diabetes AttitudesInterested in social comparison info at baseline - Strongly Agree/Agree43 participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes AttitudesInterested in social comparison info at one-month follow-up -Strongly Agree/Agree33 participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes AttitudesInterested goal-based comparison info at baseline -Strongly Agree/Agree50 participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes AttitudesInterested goal-based comparison info at one-month follow-up -Strongly Agree/Agree47 participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes AttitudesSocial comparison info is useful at baseline - Strongly Agree/Agree50 participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes AttitudesSocial comparison info is useful at one-month - Strongly Agree/Agree47 participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes AttitudesGoal-based comparison info is useful at baseline - Strongly Agree/Agree51 participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes AttitudesGoal-based comparison info is useful at one-month - Strongly Agree/Agree49 participants
Comparison: Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)p-value: 0.03McNemar
Comparison: Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)p-value: 0.45McNemar
Comparison: Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.p-value: 0.17McNemar
Comparison: Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.p-value: 0.62McNemar
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 to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the Problem Areas in Diabetes Scale (PAID-5) items on the pre- and post-questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
My Diabetes Care Mobile (MDC-m)Change in Diabetes DistressBaseline pre-questionnaire4.92 score on a scaleStandard Deviation 4.7
My Diabetes Care Mobile (MDC-m)Change in Diabetes DistressOne-month follow-up post-questionnaire4.21 score on a scaleStandard Deviation 3.8
p-value: 0.16t-test, 2 sided
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 to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the Short Diabetes Knowledge Instrument items on the pre- and post-questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
My Diabetes Care Mobile (MDC-m)Change in Diabetes KnowledgeBaseline pre-questionnaire5.37 score on a scaleStandard Deviation 1.6
My Diabetes Care Mobile (MDC-m)Change in Diabetes KnowledgeOne-month follow-up post-questionnaire6.10 score on a scaleStandard Deviation 1.5
p-value: <0.01t-test, 2 sided
Secondary

Change in Diabetes Readiness for Change

Four-item assessment of stage of change based on the Transtheoretical Model (TTM) of behavior change. It includes questions one item each assessing the participants stage of change for: (1) physical activity, (2) medication management, (3) glucose self-monitoring, and (4) diet. There are five response options per item that categorize the participants' current TTM stage of change for the item: (a) Precontemplation, (b) Contemplation, (c) Preparation, (d) Action, and (e) Maintenance.

Time frame: Baseline to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires)

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Taking MedicinesPrecontemplation0 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Taking MedicinesContemplation0 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Taking MedicinesPreparation1 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Taking MedicinesAction6 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Taking MedicinesMaintenance46 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Taking MedicinesMissing/No Answer0 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Taking MedicationsPrecontemplation1 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Taking MedicationsContemplation0 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Taking MedicationsPreparation1 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Taking MedicationsAction3 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Taking MedicationsMaintenance48 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Taking MedicationsMissing/No Answer0 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: ExercisingPrecontemplation9 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: ExercisingContemplation10 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: ExercisingPreparation9 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: ExercisingAction11 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: ExercisingMaintenance14 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: ExercisingMissing/No Answer0 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: ExercisingPrecontemplation10 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: ExercisingContemplation8 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: ExercisingPreparation5 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: ExercisingAction14 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: ExercisingMaintenance16 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: ExercisingMissing/No Answer0 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Eating HealthyPrecontemplation4 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Eating HealthyContemplation7 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Eating HealthyPreparation9 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Eating HealthyAction12 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Eating HealthyMaintenance21 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Eating HealthyMissing/No Answer0 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Healthy EatingPrecontemplation7 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Healthy EatingContemplation7 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Healthy EatingPreparation5 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Healthy EatingAction9 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Healthy EatingMaintenance24 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Healthy EatingMissing/No Answer1 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Home Glucose MonitoringPrecontemplation7 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Home Glucose MonitoringContemplation3 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Home Glucose MonitoringPreparation4 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Home Glucose MonitoringAction11 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Home Glucose MonitoringMaintenance28 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePre-intervention: Home Glucose MonitoringMissing/No Answer0 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Home Glucose MonitoringPrecontemplation8 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Home Glucose MonitoringContemplation2 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Home Glucose MonitoringPreparation1 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Home Glucose MonitoringAction11 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Home Glucose MonitoringMaintenance31 Participants
My Diabetes Care Mobile (MDC-m)Change in Diabetes Readiness for ChangePost-intervention: Home Glucose MonitoringMissing/No Answer0 Participants
Secondary

Change in Diabetes Self-Care (Exercise Adherence)

The Summary of Diabetes Self-Care Activity (SDSCA) 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 days completing recommended activities during the past 7 days. An example item includes On how many of the last SEVEN DAYS did you participate in at least 30 minutes of physical activity? The exercise subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).

Time frame: Baseline to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the items on the Summary of Diabetes Self-Care Activity - Exercise Subscale on both the pre- and post-questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-Care (Exercise Adherence)Baseline Pre-Questionnaire3.17 score on a scaleStandard Deviation 2.1
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-Care (Exercise Adherence)One-month Follow-up Post-Questionnaire3.45 score on a scaleStandard Deviation 2.2
p-value: 0.22t-test, 2 sided
Secondary

Change in Diabetes Self-Care (General Diet Adherence)

The Summary of Diabetes Self-Care Activity (SDSCA) 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 days completing recommended activities during the past 7 days. An example item includes How many of the last SEVEN DAYS have you followed a healthful eating plan? The general diet subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).

Time frame: Baseline to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the items on the Summary of Diabetes Self-Care Activity - General Diet Subscale on both the pre- and post-questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-Care (General Diet Adherence)Baseline pre-questionnaire4.74 score on a scaleStandard Deviation 1.6
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-Care (General Diet Adherence)One-month follow-up post-questionnaire4.83 score on a scaleStandard Deviation 1.6
p-value: 0.53t-test, 2 sided
Secondary

Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)

The Summary of Diabetes Self-Care Activity (SDSCA) 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 days completing recommended activities during the past 7 days. An example item includes On how many of the last SEVEN DAYS did you test your blood sugar? The blood-glucose testing subscale is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).

Time frame: Baseline to one-month Follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the items on the Summary of Diabetes Self-Care Activity - Blood-glucose Testing Subscale on both the pre- and post-questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)Baseline Pre-Questionnaire4.05 score on a scaleStandard Deviation 2.9
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)One-month Follow-up Post-Questionnaire4.3 score on a scaleStandard Deviation 2.7
p-value: 0.21t-test, 2 sided
Secondary

Change in Diabetes Self-Care (Specific Diet Adherence)

The Summary of Diabetes Self-Care Activity (SDSCA) 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 days completing recommended activities during the past 7 days. An example item includes How many of the last SEVEN DAYS have you followed a healthful eating plan? The general diet subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).

Time frame: Baseline to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the items on the Summary of Diabetes Self-Care Activity - Specific Diet Subscale on both the pre- and post-questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-Care (Specific Diet Adherence)Baseline Pre-Questionnaire4.30 score on a scaleStandard Deviation 1.6
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-Care (Specific Diet Adherence)One-month Follow-up Post-Questionnaire4.33 score on a scaleStandard Deviation 1.6
p-value: 0.86t-test, 2 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.

Time frame: Baseline to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the Perceived Diabetes Self-Management Scale items on the pre- and post-questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-EfficacyBaseline pre-questionnaire29.12 score on a scaleStandard Deviation 5.1
My Diabetes Care Mobile (MDC-m)Change in Diabetes Self-EfficacyOne-month follow-up post-questionnaire30.29 score on a scaleStandard Deviation 5.2
p-value: 0.08t-test, 2 sided
Secondary

Change in Medication Adherence

The Adherence to Refills and Medications Scale is a reliable and valid measure of medication adherence. The 12-item ARMS has good internal consistency reliability (α=0.81). 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 to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the Adherence to Refills and Medications Scale items on the pre- and post-questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
My Diabetes Care Mobile (MDC-m)Change in Medication AdherenceBaseline pre-questionnaire14.12 score on a scaleStandard Deviation 3.5
My Diabetes Care Mobile (MDC-m)Change in Medication AdherenceOne-month follow-up post-questionnaire13.73 score on a scaleStandard Deviation 3.3
p-value: 0.18t-test, 2 sided
Secondary

Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures

Unique study specific items to assess participants' knowledge of measures of diabetes health status (i.e., Hemoglobin A1C, blood pressure, low-density lipoprotein, and flu vaccination status). Each multiple choice item has one correct answer and the unit of measure is the number of participants that correctly answered each item.

Time frame: Baseline to one-month follow-up

Population: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires) AND answered all the Knowledge of Diabetes Measures items on the pre- and post-questionnaire.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify definition of A1c at baseline49 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify definition of A1c at one-month follow-up51 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify goal range for A1c at baseline30 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify goal range for A1c at one-month follow-up36 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify definition of blood pressure at baseline36 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify definition of blood pressure at one-month follow-up41 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify goal range for blood pressure at baseline16 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify goal range for blood pressure at one-month follow-up23 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify definition of LDL cholesterol at baseline32 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify definition of LDL cholesterol at one-month follow-up38 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify goal range for LDL cholesterol at baseline22 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify goal range for LDL cholesterol at one-month follow-up27 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify definition of flu vaccine at baseline52 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify definition of flu vaccine at one-month follow-up53 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify frequency of flu vaccination at baseline48 Participants
My Diabetes Care Mobile (MDC-m)Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health MeasuresIdentify frequency of flu vaccination at one-month follow-up51 Participants
Comparison: Analysis for pre-post change in knowledge of definition of A1Cp-value: 0.68McNemar
Comparison: Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.p-value: 0.18McNemar
Comparison: Analysis for pre-post change in knowledge of definition of systolic blood pressurep-value: 0.18McNemar
Comparison: Analysis of pre-post change in knowledge of goal range for systolic blood pressurep-value: 0.17McNemar
Comparison: Analysis of pre-post change in knowledge of definition of LDL cholesterolp-value: 0.33McNemar
Comparison: Analysis for pre-post change in knowledge of goal range for LDL cholesterolp-value: 0.4McNemar
Comparison: Analysis of pre-post change in knowledge of definition of flu vaccinep-value: 1McNemar
Comparison: Analysis of pre-post change in knowledge of recommended frequency of flu vaccinationp-value: 0.37McNemar

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026