Diabetes Mellitus, Type 2
Conditions
Brief summary
This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support (DSME/S) for African American/Black adults with type 2 diabetes living in Detroit. Participants will be randomized to either a control group or the virtual DSME/S group.
Detailed description
This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support (DSME/S) for African American/Black adults with type 2 diabetes living in Detroit. Participants interested in participating in this study will first be consented then they will complete a baseline health assessment including a questionnaire and physiologic testing. Using a 50/50 randomization scheme, participants will be randomized to either a control group or the virtual DSME/S group and be told of their placement. Participants randomized to the control group will receive community resources, diabetes specific newsletters, and pedometers. Participants randomized to the virtual DSME/S group will receive 10-weekly 1-hour virtual DSME/S sessions with a certified diabetes care and education specialists through Zoom for Health at the University of Michigan, a HIPPA compliant platform. After the intervention is complete and then again 3 months later, participants in both groups will be invited to complete an additional health assessment. However, due to low recruitment we removed the control arm and offered all participants virtual DSME/S.
Interventions
BEHAVIORALVirtual Diabetes Self-Management Education and Support
Diabetes self-management education and support delivered through Zoom for health.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Initially, we intended to have a control group and an intervention group. However, due to low recruitment numbers and COVID-19 pandemic barriers, we decided to offer all participants virtual DSME/S.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Agee 18 or older, Black, a diagnosis of T2D for one year duration or longer, ambulatory status.
Exclusion criteria
* Non-ambulatory, serious health conditions (morbid obesity and severe symptomatic heart disease, visual impairment, renal failure, and peripheral neuropathy), psychiatric illness (severity requiring hospitalization) or cognitive deficit (illness determined using the Montreal Cognitive Assessment tool) and serious diabetes complications (e.g. blindness) that would impede meaningful participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | baseline and at 3 months | Measured using the Patient Health Questionnaire (PHQ-9). A PHQ-9 score of 0-4 means none-minimal depression severity, a score of 5-9 means mild depression severity, a score of 10-14 means moderate depression severity, a score of 15-19 means moderately severe depression, and 20-27 means severe depression. |
| Metabolic Control of A1c (Mean Change in A1C) | baseline and at 3 months | Measured using the DCA 2000 point-of-care testing instrument. The American Diabetes Association recommends people living with diabetes to have an A1C below 7.0%. |
| Regimen Adherence | baseline and at 3 months | Measured using the Perceived Diabetes Self-Management Scale (PDSMS), a self-report questionnaire used to measure a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. For this study, we reported mean change in PDSMS score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | baseline 3 months | Calculated using height and weight. Height will be measured using a stadiometer. Weight will be measured on a high quality, calibrated digital scale. Underweight = \<18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater For this study, we reported the mean change in BMI. |
| Blood Pressure | baseline and at 3 months | Measured using the auscultatory method. The American Diabetes Association recommends people living with type 2 diabetes to have a blood pressure target of 130/80 mmHg. |
| Diabetes Social Support | baseline and at 3 months | Measured using the Chronic Illness Resources Survey. This survey has a minimum score of 22 and a maximum score of 110. The higher the value, the more support and resources someone has for managing their illness. We measured the mean change in score. |
| Diabetes-Related Distress | baseline and at 3 months | Measured using the Diabetes Distress Scale. The score is calculated by averaging 17 items on the questionnaire. Scores range from 1 to 6, with 1 being the least distressed and 6 being the most distressed. We consider a mean item score of 3 or higher (moderate distress) as a level of distress worthy of clinical attention. We reported the mean change in diabetes distress below. |
| Diabetes Quality of Life | baseline and at 3 months | Measured using the Diabetes Quality of Life Questionnaire. The 46-item DQoL scale consists of four domains and is measured using a 5-point Likert scale, where scores are averaged across all domains and summed. Scores range from 0 to 100. The higher the score, the higher the quality of life. We reported the mean change below. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Diabetes Self-Management Education and Support Participants will receive one hour of DSME/S delivered by a Certified Diabetes Care and Education Specialist (CDCES) per week for 10 weeks delivered via the Zoom for Health at U-M service may be used for Protected Health Information (PHI, regulated by HIPAA). To ensure treatment fidelity, three DSME/S sessions will be selected at random and recorded and rated for fidelity to the above content by our research team.
Virtual Diabetes Self-Management Education and Support: Diabetes self-management education and support delivered through Zoom for health. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Virtual Diabetes Self-Management Education and Support |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Depression
Measured using the Patient Health Questionnaire (PHQ-9). A PHQ-9 score of 0-4 means none-minimal depression severity, a score of 5-9 means mild depression severity, a score of 10-14 means moderate depression severity, a score of 15-19 means moderately severe depression, and 20-27 means severe depression.
Time frame: baseline and at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Depression | -0.79 units on a scale | Standard Deviation 4.14 |
Primary
Metabolic Control of A1c (Mean Change in A1C)
Measured using the DCA 2000 point-of-care testing instrument. The American Diabetes Association recommends people living with diabetes to have an A1C below 7.0%.
Time frame: baseline and at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Metabolic Control of A1c (Mean Change in A1C) | -0.02 percent | Standard Deviation 1.64 |
Primary
Regimen Adherence
Measured using the Perceived Diabetes Self-Management Scale (PDSMS), a self-report questionnaire used to measure a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. For this study, we reported mean change in PDSMS score.
Time frame: baseline and at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Regimen Adherence | 1.12 units on a scale | Standard Deviation 4.01 |
Secondary
Blood Pressure
Measured using the auscultatory method. The American Diabetes Association recommends people living with type 2 diabetes to have a blood pressure target of 130/80 mmHg.
Time frame: baseline and at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Blood Pressure | Systolic | 7.75 mmHg | Standard Deviation 14.75 |
| Virtual Diabetes Self-Management Education and Support | Blood Pressure | Diastolic | 5.33 mmHg | Standard Deviation 10.76 |
Secondary
Body Mass Index (BMI)
Calculated using height and weight. Height will be measured using a stadiometer. Weight will be measured on a high quality, calibrated digital scale. Underweight = \<18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater For this study, we reported the mean change in BMI.
Time frame: baseline 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Body Mass Index (BMI) | -0.54 kg/m^2 | Standard Deviation 10.34 |
Secondary
Diabetes Quality of Life
Measured using the Diabetes Quality of Life Questionnaire. The 46-item DQoL scale consists of four domains and is measured using a 5-point Likert scale, where scores are averaged across all domains and summed. Scores range from 0 to 100. The higher the score, the higher the quality of life. We reported the mean change below.
Time frame: baseline and at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Diabetes Quality of Life | 0.14 units on a scale | Standard Deviation 0.65 |
Secondary
Diabetes-Related Distress
Measured using the Diabetes Distress Scale. The score is calculated by averaging 17 items on the questionnaire. Scores range from 1 to 6, with 1 being the least distressed and 6 being the most distressed. We consider a mean item score of 3 or higher (moderate distress) as a level of distress worthy of clinical attention. We reported the mean change in diabetes distress below.
Time frame: baseline and at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Diabetes-Related Distress | -5.72 units on a scale | Standard Deviation 14.46 |
Secondary
Diabetes Social Support
Measured using the Chronic Illness Resources Survey. This survey has a minimum score of 22 and a maximum score of 110. The higher the value, the more support and resources someone has for managing their illness. We measured the mean change in score.
Time frame: baseline and at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Diabetes Social Support | 0.48 units on a scale | Standard Deviation 1.23 |