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 (MDC) mobile intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.
Detailed description
Up to 90 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care (MDC). 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) and provides literacy level-appropriate and tailored diabetes selfcare 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 a 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 MDC for 1 month.
Interventions
My Diabetes Care (MDC) is a multi-faceted patient portal intervention 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) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency.
Sponsors
Study design
Eligibility
Inclusion criteria
* Type 2 Diabetes Mellitus * Age 18-75 years old * Currently taking at least one medication for diabetes * Patient at a participating clinic within Vanderbilt Medical Center or Brigham and Women's Hospital * Able to speak and read in English or Spanish * Reliable access to a smartphone or tablet with internet access * Active patient web portal account (for example, My Health at Vanderbilt or Patient Gateway)
Exclusion criteria
* Have a medical condition that affects your memory or ability to think * Have severe difficulty seeing or hearing * Have a medical condition that makes it hard for people to understand what you are saying
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability | One month follow-up (t1) | 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 71 or above suggests 'good' usability. |
| System Usage | One month follow-up (t1) | System usage will be assessed by user analytics data capturing participant use to MDC during the study period. MDC use is defined as one or more visits to the MDC site during the study period. |
| User Experience - Acceptance | One month follow-up (t1) | User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). Survey items will assess agreement on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Participants will be asked whether they would continue to use My Diabetes Care (MDC) going forward were it to remain available and whether they would recommend MDC to other patients with diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Self-Care - Glucose Self-monitoring Adherence | Baseline (t0) to one month follow-up (t1) | The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess glucose self-monitoring adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. The blood-glucose testing 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 (t0) to one month follow-up (t1) | 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 Medication Adherence | Baseline (t0) to one month follow-up (t1) | The Adherence to Refills and Medications Scale is a reliable and valid measure of medication adherence. The 12-item scale has item responses range that from 1=none of the time to 4=all of the time. Responses are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence. |
| Change in Diabetes Knowledge | Baseline (t0) to one month follow-up (t1) | The Revised Brief Diabetes Knowledge Test (DKT2) is a valid measure of diabetes knowledge. The 14-item questionnaire was designed to assess a patient's understanding of diabetes management. The DKT2 is a uni-dimensional, 14-item scale with scores ranging from 0 to 14 (number of items answered correctly). Higher scores indicate greater knowledge. |
| Change in Knowledge of Diabetes Measures | Baseline (t0) to one month follow-up (t1) | Unique study specific items to assess participants' knowledge of measures of diabetes health status (i.e., hemoglobin A1C, blood pressure, low-density lipoprotein, urine microalbumin, and body mass index). Each item has 1 correct answer and several incorrect answers. |
| Change in Diabetes Readiness for Change | Baseline (t0) to one month follow-up (t1) | Four-item assess the participants' stage of change based on the Transtheoretical Model (TTM) of behavior change including one item each 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 across a continuum: (a) Precontemplation \[worst\], (b) Contemplation, (c) Preparation, (d) Action, and (e) Maintenance \[best\]. For each item, precontemplation is represented by the response No, and I do not intend to in the next 6 months; contemplation is represented by the response No, but I am thinking about starting in the next 6 months; Preparation is represented by the response No, but I am planning to start in the next 30 days; action is represented by the response Yes, I have been for less than 6 months; and maintenance is represented by the response Yes, I have been for 6 months or more. |
| Change in Diabetes Distress | Baseline (t0) to one month follow-up (t1) | 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 is associated with measures of depression and hemoglobin A1c. |
| Change in Diabetes Self-Care - Diet Adherence | Baseline (t0) to one month follow-up (t1) | The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess 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-Care - Exercise Adherence | Baseline (t0) to one month follow-up (t1) | The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: diet (4 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. 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). |
Countries
United States
Participant flow
Pre-assignment details
Of the enrolled participants, 63 completed the baseline questionnaire and were then assigned to the intervention.
Participants by arm
| Arm | Count |
|---|---|
| My Diabetes Care (MDC) Patients have access to a patient web portal embedded with the My Diabetes Care (MDC) intervention.
MDC is a multi-faceted patient portal intervention 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) and provides literacy level-appropriate diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency. | 63 |
| Total | 63 |
Baseline characteristics
| Characteristic | My Diabetes Care (MDC) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 57.2 years STANDARD_DEVIATION 12.6 |
| Language English | 57 Participants |
| Language Spanish | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 18 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White or Caucasian | 41 Participants |
| Region of Enrollment United States | 63 participants |
| Sex/Gender, Customized Female | 36 Participants |
| Sex/Gender, Customized Male | 26 Participants |
| Sex/Gender, Customized Other | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 63 |
| other Total, other adverse events | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
System Usage
System usage will be assessed by user analytics data capturing participant use to MDC during the study period. MDC use is defined as one or more visits to the MDC site during the study period.
Time frame: One month follow-up (t1)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| My Diabetes Care (MDC) | System Usage | Yes | 49 Participants |
| My Diabetes Care (MDC) | System Usage | No | 14 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 71 or above suggests 'good' usability.
Time frame: One month follow-up (t1)
Population: 47 participants used to the study intervention during the study period and completed the SUS scale.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| My Diabetes Care (MDC) | Usability | 75.0 score on a scale |
User Experience - Acceptance
User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). Survey items will assess agreement on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Participants will be asked whether they would continue to use My Diabetes Care (MDC) going forward were it to remain available and whether they would recommend MDC to other patients with diabetes.
Time frame: One month follow-up (t1)
Population: Analysis was limited to participants that used MDC during the study period and participants who responded to the items below on the one month follow-up questionnaire (t1).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| My Diabetes Care (MDC) | User Experience - Acceptance | Would recommend the intervention to other patients | Strongly agree/ agree | 42 Participants |
| My Diabetes Care (MDC) | User Experience - Acceptance | Would recommend the intervention to other patients | Neutral/ disagree/ strongly disagree | 7 Participants |
| My Diabetes Care (MDC) | User Experience - Acceptance | Would continue to use the intervention in future if it remained available | Strongly agree/ agree | 37 Participants |
| My Diabetes Care (MDC) | User Experience - Acceptance | Would continue to use the intervention in future if it remained available | Neutral/ disagree/ strongly disagree | 10 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 is associated with measures of depression and hemoglobin A1c.
Time frame: Baseline (t0) to one month follow-up (t1)
Population: Analysis was limited to participants that used MDC during the study period and completed the Problem Areas in Diabetes Scale (PAID-5) on the baseline (t0) and one-month follow-up (t1) questionnaires.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| My Diabetes Care (MDC) | Change in Diabetes Distress | baseline questionnaire (t0) | 6.0 score on a scale |
| My Diabetes Care (MDC) | Change in Diabetes Distress | one-month questionnaire follow-up (t1) | 5.0 score on a scale |
Change in Diabetes Knowledge
The Revised Brief Diabetes Knowledge Test (DKT2) is a valid measure of diabetes knowledge. The 14-item questionnaire was designed to assess a patient's understanding of diabetes management. The DKT2 is a uni-dimensional, 14-item scale with scores ranging from 0 to 14 (number of items answered correctly). Higher scores indicate greater knowledge.
Time frame: Baseline (t0) to one month follow-up (t1)
Population: Analysis was limited to participants that used MDC during the study period and completed the Short Diabetes Knowledge Instrument (SDKI) on the baseline (t0) and one-month follow-up (t1) questionnaires.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| My Diabetes Care (MDC) | Change in Diabetes Knowledge | baseline questionnaire (t0) | 12.0 score on a scale |
| My Diabetes Care (MDC) | Change in Diabetes Knowledge | one-month follow-up questionnaire (t1) | 12.0 score on a scale |
Change in Diabetes Readiness for Change
Four-item assess the participants' stage of change based on the Transtheoretical Model (TTM) of behavior change including one item each 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 across a continuum: (a) Precontemplation \[worst\], (b) Contemplation, (c) Preparation, (d) Action, and (e) Maintenance \[best\]. For each item, precontemplation is represented by the response No, and I do not intend to in the next 6 months; contemplation is represented by the response No, but I am thinking about starting in the next 6 months; Preparation is represented by the response No, but I am planning to start in the next 30 days; action is represented by the response Yes, I have been for less than 6 months; and maintenance is represented by the response Yes, I have been for 6 months or more.
Time frame: Baseline (t0) to one month follow-up (t1)
Population: Analysis is limited to participants that (1) used MDC during the study period AND (2) completed the survey items at the corresponding timepoints pre-intervention (t0) and post-intervention (T1).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. | Precontemplation | 2 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. | Contemplation | 7 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. | Preparation | 19 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. | Action | 5 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. | Maintenance | 11 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. | Precontemplation | 1 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. | Contemplation | 6 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. | Preparation | 19 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. | Action | 11 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. | Maintenance | 7 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends | Precontemplation | 1 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends | Contemplation | 7 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends | Preparation | 6 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends | Action | 10 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends | Maintenance | 19 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends | Precontemplation | 3 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends | Contemplation | 1 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends | Preparation | 6 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends | Action | 12 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends | Maintenance | 22 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): follow a healthy diet for people with diabetes | Precontemplation | 2 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): follow a healthy diet for people with diabetes | Contemplation | 5 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): follow a healthy diet for people with diabetes | Preparation | 12 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): follow a healthy diet for people with diabetes | Action | 9 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): follow a healthy diet for people with diabetes | Maintenance | 16 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): follow a healthy diet for people with diabetes | Precontemplation | 0 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): follow a healthy diet for people with diabetes | Contemplation | 3 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): follow a healthy diet for people with diabetes | Preparation | 11 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): follow a healthy diet for people with diabetes | Action | 9 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): follow a healthy diet for people with diabetes | Maintenance | 21 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): take your medicines every day as prescribed | Precontemplation | 0 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): take your medicines every day as prescribed | Contemplation | 0 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): take your medicines every day as prescribed | Preparation | 0 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): take your medicines every day as prescribed | Action | 3 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Pre-Intervention (t0): take your medicines every day as prescribed | Maintenance | 41 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): take your medicines every day as prescribed | Precontemplation | 1 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): take your medicines every day as prescribed | Contemplation | 0 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): take your medicines every day as prescribed | Preparation | 2 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): take your medicines every day as prescribed | Action | 2 Participants |
| My Diabetes Care (MDC) | Change in Diabetes Readiness for Change | Post-Intervention (t1): take your medicines every day as prescribed | Maintenance | 39 Participants |
Change in Diabetes Self-Care - 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: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess 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 (t0) to one month follow-up (t1)
Population: Analysis was limited to participants that used MDC during the study period and completed the Summary of Diabetes Self-Care Activity (SDSCA) scale diet subdomain on the baseline (t0) and one-month follow-up (t1) questionnaires.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| My Diabetes Care (MDC) | Change in Diabetes Self-Care - Diet Adherence | baseline (t0) questionnaire | 4.0 score on a scale |
| My Diabetes Care (MDC) | Change in Diabetes Self-Care - Diet Adherence | one-month follow-up (T1) questionnaire | 4.8 score on a scale |
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: diet (4 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. 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 (t0) to one month follow-up (t1)
Population: Analysis was limited to participants that used MDC during the study period and completed the Summary of Diabetes Self-Care Activity (SDSCA) scale exercise subdomain on the baseline (t0) and one-month follow-up (t1) questionnaires.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| My Diabetes Care (MDC) | Change in Diabetes Self-Care - Exercise Adherence | baseline (t0) questionnaire | 2.0 score on a scale |
| My Diabetes Care (MDC) | Change in Diabetes Self-Care - Exercise Adherence | one-month follow-up (T1) questionnaire | 2.0 score on a scale |
Change in Diabetes Self-Care - Glucose Self-monitoring 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: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess glucose self-monitoring adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. The blood-glucose testing 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 (t0) to one month follow-up (t1)
Population: Analysis was limited to participants that used MDC during the study period and completed the Summary of Diabetes Self-Care Activity (SDSCA) scale exercise subdomain on the baseline (t0) and one-month follow-up (t1) questionnaires.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| My Diabetes Care (MDC) | Change in Diabetes Self-Care - Glucose Self-monitoring Adherence | baseline (t0) questionnaire | 4.0 score on a scale |
| My Diabetes Care (MDC) | Change in Diabetes Self-Care - Glucose Self-monitoring Adherence | one-month follow-up (T1) questionnaire | 4.0 score on a scale |
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 (t0) to one month follow-up (t1)
Population: Analysis was limited to participants that used MDC during the study period and completed the Perceived Diabetes Self-Management Scale (PDSMS) on the baseline (t0) and one-month follow-up (t1) questionnaires.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| My Diabetes Care (MDC) | Change in Diabetes Self-Efficacy | baseline questionnaire (t0) | 25.0 score on a scale |
| My Diabetes Care (MDC) | Change in Diabetes Self-Efficacy | one-month follow-up questionnaire (t1) | 25.0 score on a scale |
Change in Knowledge of Diabetes Measures
Unique study specific items to assess participants' knowledge of measures of diabetes health status (i.e., hemoglobin A1C, blood pressure, low-density lipoprotein, urine microalbumin, and body mass index). Each item has 1 correct answer and several incorrect answers.
Time frame: Baseline (t0) to one month follow-up (t1)
Population: Analysis was limited to participants that used MDC during the study period.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of BMI? | Incorrect | 4 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of A1c? | Correct | 47 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of A1c? | Incorrect | 2 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for A1c? | Correct | 27 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for A1c? | Incorrect | 22 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of systolic blood pressure? | Correct | 24 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of systolic blood pressure? | Incorrect | 24 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for systolic blood pressure? | Correct | 16 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for systolic blood pressure? | Incorrect | 33 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of LDL cholesterol? | Correct | 30 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of LDL cholesterol? | Incorrect | 19 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for LDL cholesterol? | Correct | 18 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for LDL cholesterol? | Incorrect | 31 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of urine microalbumin? | Correct | 28 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of urine microalbumin? | Incorrect | 21 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for urine microalbumin? | Correct | 13 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for urine microalbumin? | Incorrect | 36 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of BMI? | Correct | 46 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Definition of BMI? | Incorrect | 3 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for BMI? | Correct | 18 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Pre-Intervention (t0): Goal range for BMI? | Incorrect | 31 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of A1c? | Correct | 46 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of A1c? | Incorrect | 3 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for A1c? | Correct | 30 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for A1c? | Incorrect | 19 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of systolic blood pressure? | Correct | 31 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of systolic blood pressure? | Incorrect | 18 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for systolic blood pressure? | Correct | 19 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for systolic blood pressure? | Incorrect | 30 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of LDL cholesterol? | Correct | 37 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of LDL cholesterol? | Incorrect | 12 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for LDL cholesterol? | Correct | 23 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for LDL cholesterol? | Incorrect | 26 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of urine microalbumin? | Correct | 33 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of urine microalbumin? | Incorrect | 16 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for urine microalbumin? | Correct | 16 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for urine microalbumin? | Incorrect | 33 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Definition of BMI? | Correct | 45 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for BMI? | Correct | 23 Participants |
| My Diabetes Care (MDC) | Change in Knowledge of Diabetes Measures | Post-Intervention (t1): Goal range for BMI? | Incorrect | 26 Participants |
Change in Medication Adherence
The Adherence to Refills and Medications Scale is a reliable and valid measure of medication adherence. The 12-item scale has item responses range that from 1=none of the time to 4=all of the time. Responses are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence.
Time frame: Baseline (t0) to one month follow-up (t1)
Population: Analysis was limited to participants that used MDC during the study period and completed the Adherence to Refills and Medications Scale on the baseline (t0) and one-month follow-up (t1) questionnaires.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| My Diabetes Care (MDC) | Change in Medication Adherence | baseline questionnaire (t0) | 15.0 score on a scale |
| My Diabetes Care (MDC) | Change in Medication Adherence | one-month follow-up questionnaire (t1) | 15.0 score on a scale |