Trial Outcomes & Findings for My Diabetes Care Mobile: A Usability Study (NCT NCT04894916)
NCT ID: NCT04894916
Last Updated: 2022-11-10
Results Overview
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).
COMPLETED
NA
64 participants
One-month follow-up
2022-11-10
Participant Flow
Of the 64 enrolled participants, 59 completed the baseline questionnaire and were with given access to the intervention (My Diabetes Care).
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
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53
|
|
Overall Study
NOT COMPLETED
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6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
My Diabetes Care Mobile: A Usability Study
Baseline characteristics by cohort
| Measure |
My Diabetes Care Mobile (MDC-m)
n=59 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
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33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Education
High school graduate or GED
|
5 Participants
n=5 Participants
|
|
Education
Some college or technical school
|
14 Participants
n=5 Participants
|
|
Education
College graduate
|
16 Participants
n=5 Participants
|
|
Education
Some graduate school/work
|
6 Participants
n=5 Participants
|
|
Education
Graduate degree
|
18 Participants
n=5 Participants
|
|
Employment
Full time
|
23 Participants
n=5 Participants
|
|
Employment
Part time
|
4 Participants
n=5 Participants
|
|
Employment
Unemployed/laid off, looking for work
|
1 Participants
n=5 Participants
|
|
Employment
Retired
|
21 Participants
n=5 Participants
|
|
Employment
Disabled, not able to work
|
7 Participants
n=5 Participants
|
|
Employment
Others
|
3 Participants
n=5 Participants
|
|
Health Literacy
Adequate
|
51 Participants
n=5 Participants
|
|
Health Literacy
Limited
|
8 Participants
n=5 Participants
|
|
eHealth Literacy
|
32.8 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: One-month follow-upPopulation: 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.
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
| Measure |
My Diabetes Care Mobile (MDC-m)
n=52 Participants
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.
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|---|---|
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Usability
|
81.9 score on a scale
Standard Deviation 15.4
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PRIMARY outcome
Timeframe: One-month follow-upPopulation: Number analyzed includes only participants that answered the survey items. One participant did not answer the items.
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.
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=58 Participants
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.
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|---|---|
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System Usage Data
Did you use My Diabetes Care during the study period? · Yes
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54 Participants
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System Usage Data
Did you use My Diabetes Care during the study period? · No
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4 Participants
|
|
System Usage Data
Did you use My Diabetes Care for 10 minutes or more? · Yes
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47 Participants
|
|
System Usage Data
Did you use My Diabetes Care for 10 minutes or more? · No
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11 Participants
|
PRIMARY outcome
Timeframe: One-month follow-upUnique study specific items to assess participants' perspectives on the usefulness of particular My Diabetes Care features and functionality.
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=53 Participants
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.
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|---|---|
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User Experience
Patients Like Me Data - useful
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25 participants
|
|
User Experience
Make a Change for the Better module - useful
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21 participants
|
|
User Experience
Question Mark Icon - useful
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25 participants
|
|
User Experience
Goal, Caution, and Warning Ranges - useful
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40 participants
|
|
User Experience
Graphs showing trends in your diabetes health data over time - useful
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41 participants
|
|
User Experience
Literacy level appropriate educational links about each diabetes health measure - useful
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24 participants
|
|
User Experience
Literacy level appropriate educational links with tips to improve your diabetes - useful
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22 participants
|
|
User Experience
Diabetes Online Community - useful
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8 participants
|
SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: 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.
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
| Measure |
My Diabetes Care Mobile (MDC-m)
n=49 Participants
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.
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|---|---|
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Change in Diabetes Knowledge
Baseline pre-questionnaire
|
5.37 score on a scale
Standard Deviation 1.6
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Change in Diabetes Knowledge
One-month follow-up post-questionnaire
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6.10 score on a scale
Standard Deviation 1.5
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SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=50 Participants
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.
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|---|---|
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Change in Diabetes Self-Efficacy
Baseline pre-questionnaire
|
29.12 score on a scale
Standard Deviation 5.1
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Change in Diabetes Self-Efficacy
One-month follow-up post-questionnaire
|
30.29 score on a scale
Standard Deviation 5.2
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SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=53 Participants
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.
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|---|---|
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Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures
Identify definition of A1c at baseline
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49 Participants
|
|
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
|
|
Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures
Identify goal range for A1c at baseline
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30 Participants
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: 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.
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
| Measure |
My Diabetes Care Mobile (MDC-m)
n=50 Participants
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.
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|---|---|
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Change in Diabetes Distress
Baseline pre-questionnaire
|
4.92 score on a scale
Standard Deviation 4.7
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Change in Diabetes Distress
One-month follow-up post-questionnaire
|
4.21 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: 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.
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'.
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=53 Participants
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.
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|---|---|
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Change in Diabetes Attitudes
Social comparison info is useful at one-month - Strongly Agree/Agree
|
47 participants
|
|
Change in Diabetes Attitudes
Interested in social comparison info at baseline - Strongly Agree/Agree
|
43 participants
|
|
Change in Diabetes Attitudes
Interested in social comparison info at one-month follow-up -Strongly Agree/Agree
|
33 participants
|
|
Change in Diabetes Attitudes
Interested goal-based comparison info at baseline -Strongly Agree/Agree
|
50 participants
|
|
Change in Diabetes Attitudes
Interested goal-based comparison info at one-month follow-up -Strongly Agree/Agree
|
47 participants
|
|
Change in Diabetes Attitudes
Social comparison info is useful at baseline - Strongly Agree/Agree
|
50 participants
|
|
Change in Diabetes Attitudes
Goal-based comparison info is useful at baseline - Strongly Agree/Agree
|
51 participants
|
|
Change in Diabetes Attitudes
Goal-based comparison info is useful at one-month - Strongly Agree/Agree
|
49 participants
|
SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: Participants that completed the study (i.e., used the intervention and complete pre- and post-questionnaires)
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.
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=53 Participants
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.
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|---|---|
|
Change in Diabetes Readiness for Change
Pre-intervention: Home Glucose Monitoring · Action
|
11 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Taking Medicines · Precontemplation
|
0 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Taking Medicines · Contemplation
|
0 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Taking Medicines · Preparation
|
1 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Taking Medicines · Action
|
6 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Taking Medicines · Maintenance
|
46 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Taking Medicines · Missing/No Answer
|
0 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Taking Medications · Precontemplation
|
1 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Taking Medications · Contemplation
|
0 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Taking Medications · Preparation
|
1 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Taking Medications · Action
|
3 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Taking Medications · Maintenance
|
48 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Taking Medications · Missing/No Answer
|
0 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Exercising · Precontemplation
|
9 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Exercising · Contemplation
|
10 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Exercising · Preparation
|
9 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Exercising · Action
|
11 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Exercising · Maintenance
|
14 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Exercising · Missing/No Answer
|
0 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Exercising · Precontemplation
|
10 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Exercising · Contemplation
|
8 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Exercising · Preparation
|
5 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Exercising · Action
|
14 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Exercising · Maintenance
|
16 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Exercising · Missing/No Answer
|
0 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Eating Healthy · Precontemplation
|
4 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Eating Healthy · Contemplation
|
7 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Eating Healthy · Preparation
|
9 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Eating Healthy · Action
|
12 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Eating Healthy · Maintenance
|
21 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Eating Healthy · Missing/No Answer
|
0 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Healthy Eating · Precontemplation
|
7 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Healthy Eating · Contemplation
|
7 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Healthy Eating · Preparation
|
5 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Healthy Eating · Action
|
9 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Healthy Eating · Maintenance
|
24 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Healthy Eating · Missing/No Answer
|
1 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Home Glucose Monitoring · Precontemplation
|
7 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Home Glucose Monitoring · Contemplation
|
3 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Home Glucose Monitoring · Preparation
|
4 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Home Glucose Monitoring · Maintenance
|
28 Participants
|
|
Change in Diabetes Readiness for Change
Pre-intervention: Home Glucose Monitoring · Missing/No Answer
|
0 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Home Glucose Monitoring · Precontemplation
|
8 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Home Glucose Monitoring · Contemplation
|
2 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Home Glucose Monitoring · Preparation
|
1 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Home Glucose Monitoring · Action
|
11 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Home Glucose Monitoring · Maintenance
|
31 Participants
|
|
Change in Diabetes Readiness for Change
Post-intervention: Home Glucose Monitoring · Missing/No Answer
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: 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.
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).
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=51 Participants
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.
|
|---|---|
|
Change in Diabetes Self-Care (General Diet Adherence)
Baseline pre-questionnaire
|
4.74 score on a scale
Standard Deviation 1.6
|
|
Change in Diabetes Self-Care (General Diet Adherence)
One-month follow-up post-questionnaire
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4.83 score on a scale
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: 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.
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).
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=51 Participants
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.
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Change in Diabetes Self-Care (Specific Diet Adherence)
Baseline Pre-Questionnaire
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4.30 score on a scale
Standard Deviation 1.6
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Change in Diabetes Self-Care (Specific Diet Adherence)
One-month Follow-up Post-Questionnaire
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4.33 score on a scale
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: 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.
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).
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=51 Participants
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.
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Change in Diabetes Self-Care (Exercise Adherence)
Baseline Pre-Questionnaire
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3.17 score on a scale
Standard Deviation 2.1
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Change in Diabetes Self-Care (Exercise Adherence)
One-month Follow-up Post-Questionnaire
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3.45 score on a scale
Standard Deviation 2.2
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SECONDARY outcome
Timeframe: Baseline to one-month Follow-upPopulation: 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.
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).
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=51 Participants
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.
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Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)
Baseline Pre-Questionnaire
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4.05 score on a scale
Standard Deviation 2.9
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Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)
One-month Follow-up Post-Questionnaire
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4.3 score on a scale
Standard Deviation 2.7
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SECONDARY outcome
Timeframe: Baseline to one-month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
My Diabetes Care Mobile (MDC-m)
n=47 Participants
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.
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Change in Medication Adherence
Baseline pre-questionnaire
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14.12 score on a scale
Standard Deviation 3.5
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Change in Medication Adherence
One-month follow-up post-questionnaire
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13.73 score on a scale
Standard Deviation 3.3
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Adverse Events
My Diabetes Care Mobile (MDC-m)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place