Diabetes Mellitus, Type 2
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Usability | One-month follow-up | The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91). |
| System Usage Data | One-month follow-up | 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. |
| User Experience | One-month follow-up | Unique study specific items to assess participants' perspectives on the usefulness of particular My Diabetes Care features and functionality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Distress | Baseline to one-month follow-up | The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The five-item, uni-dimensional scale has scores that range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. The PAID-5 has excellent excellent internal consistency reliability (Cronbach's alpha 0.86) and is associated with measures of depression and hemoglobin A1c. |
| Change in Diabetes Attitudes | Baseline to one-month follow-up | 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'. |
| Change in Diabetes Readiness for Change | Baseline to one-month follow-up | 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. |
| Change in Diabetes Self-Care (General Diet Adherence) | Baseline to one-month follow-up | 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). |
| Change in Diabetes Knowledge | Baseline to one-month follow-up | The Short Diabetes Knowledge Instrument (SDKI) is a valid measure of diabetes knowledge with an emphasis on controlling blood glucose through diet, recognizing symptoms of abnormal blood glucose, and using healthy eating to prevent complications. It also includes items on foot care and the importance of physical activity for preventing cardiovascular complications. The SDKI is a uni-dimensional, 13-item scale with scores ranging from 0 to 13 (number of items answered correctly). SDKI demonstrated good internal consistency reliability (Cronbach's alpha 0.73) in a multi-ethnic sample of older adults suggesting the instrument can be used to measure diabetes knowledge in diverse populations (Quandt et al. Diabetes Educator, 2014). |
| Change in Diabetes Self-Care (Exercise Adherence) | Baseline to one-month follow-up | 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). |
| Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) | Baseline to one-month Follow-up | 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). |
| Change in Medication Adherence | Baseline to one-month follow-up | 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. |
| Change in Diabetes Self-Care (Specific Diet Adherence) | Baseline to one-month follow-up | 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). |
| Change in Diabetes Self-Efficacy | Baseline to one-month follow-up | The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. |
| Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Baseline to one-month follow-up | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 59 |
Baseline characteristics
| Characteristic | My 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, Continuous | 58.5 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 Literacy | 32.8 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 type | EG000 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
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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | System Usage Data | Did you use My Diabetes Care during the study period? | Yes | 54 Participants |
| My Diabetes Care Mobile (MDC-m) | System Usage Data | Did you use My Diabetes Care during the study period? | No | 4 Participants |
| My Diabetes Care Mobile (MDC-m) | System Usage Data | Did you use My Diabetes Care for 10 minutes or more? | Yes | 47 Participants |
| My Diabetes Care Mobile (MDC-m) | System Usage Data | Did you use My Diabetes Care for 10 minutes or more? | No | 11 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Usability | 81.9 score on a scale | Standard Deviation 15.4 |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | User Experience | Question Mark Icon - useful | 25 participants |
| My Diabetes Care Mobile (MDC-m) | User Experience | Goal, Caution, and Warning Ranges - useful | 40 participants |
| My Diabetes Care Mobile (MDC-m) | User Experience | Graphs showing trends in your diabetes health data over time - useful | 41 participants |
| My Diabetes Care Mobile (MDC-m) | User Experience | Patients Like Me Data - useful | 25 participants |
| My Diabetes Care Mobile (MDC-m) | User Experience | Literacy level appropriate educational links about each diabetes health measure - useful | 24 participants |
| My Diabetes Care Mobile (MDC-m) | User Experience | Make a Change for the Better module - useful | 21 participants |
| My Diabetes Care Mobile (MDC-m) | User Experience | Literacy level appropriate educational links with tips to improve your diabetes - useful | 22 participants |
| My Diabetes Care Mobile (MDC-m) | User Experience | Diabetes Online Community - useful | 8 participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Attitudes | Interested in social comparison info at baseline - Strongly Agree/Agree | 43 participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Attitudes | Interested in social comparison info at one-month follow-up -Strongly Agree/Agree | 33 participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Attitudes | Interested goal-based comparison info at baseline -Strongly Agree/Agree | 50 participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Attitudes | Interested goal-based comparison info at one-month follow-up -Strongly Agree/Agree | 47 participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Attitudes | Social comparison info is useful at baseline - Strongly Agree/Agree | 50 participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Attitudes | Social comparison info is useful at one-month - Strongly Agree/Agree | 47 participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Attitudes | Goal-based comparison info is useful at baseline - Strongly Agree/Agree | 51 participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Attitudes | Goal-based comparison info is useful at one-month - Strongly Agree/Agree | 49 participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Distress | Baseline pre-questionnaire | 4.92 score on a scale | Standard Deviation 4.7 |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Distress | One-month follow-up post-questionnaire | 4.21 score on a scale | Standard Deviation 3.8 |
Change in Diabetes Knowledge
The Short Diabetes Knowledge Instrument (SDKI) is a valid measure of diabetes knowledge with an emphasis on controlling blood glucose through diet, recognizing symptoms of abnormal blood glucose, and using healthy eating to prevent complications. It also includes items on foot care and the importance of physical activity for preventing cardiovascular complications. The SDKI is a uni-dimensional, 13-item scale with scores ranging from 0 to 13 (number of items answered correctly). SDKI demonstrated good internal consistency reliability (Cronbach's alpha 0.73) in a multi-ethnic sample of older adults suggesting the instrument can be used to measure diabetes knowledge in diverse populations (Quandt et al. Diabetes Educator, 2014).
Time frame: Baseline 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Knowledge | Baseline pre-questionnaire | 5.37 score on a scale | Standard Deviation 1.6 |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Knowledge | One-month follow-up post-questionnaire | 6.10 score on a scale | Standard Deviation 1.5 |
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)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Taking Medicines | Precontemplation | 0 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Taking Medicines | Contemplation | 0 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Taking Medicines | Preparation | 1 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Taking Medicines | Action | 6 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Taking Medicines | Maintenance | 46 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Taking Medicines | Missing/No Answer | 0 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Taking Medications | Precontemplation | 1 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Taking Medications | Contemplation | 0 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Taking Medications | Preparation | 1 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Taking Medications | Action | 3 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Taking Medications | Maintenance | 48 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Taking Medications | Missing/No Answer | 0 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Exercising | Precontemplation | 9 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Exercising | Contemplation | 10 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Exercising | Preparation | 9 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Exercising | Action | 11 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Exercising | Maintenance | 14 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Exercising | Missing/No Answer | 0 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Exercising | Precontemplation | 10 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Exercising | Contemplation | 8 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Exercising | Preparation | 5 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Exercising | Action | 14 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Exercising | Maintenance | 16 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Exercising | Missing/No Answer | 0 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Eating Healthy | Precontemplation | 4 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Eating Healthy | Contemplation | 7 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Eating Healthy | Preparation | 9 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Eating Healthy | Action | 12 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Eating Healthy | Maintenance | 21 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Eating Healthy | Missing/No Answer | 0 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Healthy Eating | Precontemplation | 7 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Healthy Eating | Contemplation | 7 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Healthy Eating | Preparation | 5 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Healthy Eating | Action | 9 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Healthy Eating | Maintenance | 24 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Healthy Eating | Missing/No Answer | 1 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Home Glucose Monitoring | Precontemplation | 7 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Home Glucose Monitoring | Contemplation | 3 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Home Glucose Monitoring | Preparation | 4 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Home Glucose Monitoring | Action | 11 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Home Glucose Monitoring | Maintenance | 28 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Pre-intervention: Home Glucose Monitoring | Missing/No Answer | 0 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Home Glucose Monitoring | Precontemplation | 8 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Home Glucose Monitoring | Contemplation | 2 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Home Glucose Monitoring | Preparation | 1 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Home Glucose Monitoring | Action | 11 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Home Glucose Monitoring | Maintenance | 31 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Readiness for Change | Post-intervention: Home Glucose Monitoring | Missing/No Answer | 0 Participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Self-Care (Exercise Adherence) | Baseline Pre-Questionnaire | 3.17 score on a scale | Standard Deviation 2.1 |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Self-Care (Exercise Adherence) | One-month Follow-up Post-Questionnaire | 3.45 score on a scale | Standard Deviation 2.2 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Self-Care (General Diet Adherence) | Baseline pre-questionnaire | 4.74 score on a scale | Standard Deviation 1.6 |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Self-Care (General Diet Adherence) | One-month follow-up post-questionnaire | 4.83 score on a scale | Standard Deviation 1.6 |
Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)
The Summary of Diabetes Self-Care Activity (SDSCA) 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) | Baseline Pre-Questionnaire | 4.05 score on a scale | Standard 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-Questionnaire | 4.3 score on a scale | Standard Deviation 2.7 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Self-Care (Specific Diet Adherence) | Baseline Pre-Questionnaire | 4.30 score on a scale | Standard Deviation 1.6 |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Self-Care (Specific Diet Adherence) | One-month Follow-up Post-Questionnaire | 4.33 score on a scale | Standard Deviation 1.6 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Self-Efficacy | Baseline pre-questionnaire | 29.12 score on a scale | Standard Deviation 5.1 |
| My Diabetes Care Mobile (MDC-m) | Change in Diabetes Self-Efficacy | One-month follow-up post-questionnaire | 30.29 score on a scale | Standard Deviation 5.2 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Medication Adherence | Baseline pre-questionnaire | 14.12 score on a scale | Standard Deviation 3.5 |
| My Diabetes Care Mobile (MDC-m) | Change in Medication Adherence | One-month follow-up post-questionnaire | 13.73 score on a scale | Standard Deviation 3.3 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify definition of A1c at baseline | 49 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify definition of A1c at one-month follow-up | 51 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify goal range for A1c at baseline | 30 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify goal range for A1c at one-month follow-up | 36 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify definition of blood pressure at baseline | 36 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify definition of blood pressure at one-month follow-up | 41 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify goal range for blood pressure at baseline | 16 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify goal range for blood pressure at one-month follow-up | 23 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify definition of LDL cholesterol at baseline | 32 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify definition of LDL cholesterol at one-month follow-up | 38 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify goal range for LDL cholesterol at baseline | 22 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify goal range for LDL cholesterol at one-month follow-up | 27 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify definition of flu vaccine at baseline | 52 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify definition of flu vaccine at one-month follow-up | 53 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify frequency of flu vaccination at baseline | 48 Participants |
| My Diabetes Care Mobile (MDC-m) | Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures | Identify frequency of flu vaccination at one-month follow-up | 51 Participants |