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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK092926 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Behavioral | Diabetes self-management education and support delivered through Zoom for health. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | baseline and at 3 months |
| 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. | baseline and at 3 months |
| 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. | baseline and at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaclynn Hawkins, MSW, PhD | University of Michigan, School of Social Work | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%. | Posted | Mean | Standard Deviation | percent | baseline and at 3 months |
|
3 months (duration of study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaclynn Hawkins | University of Michigan, School of Social Work | (734) 615-2817 | jachawk@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2021 | Mar 2, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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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.
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| 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. | baseline and at 3 months |
| 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. | baseline and at 3 months |
| 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. | baseline and at 3 months |
| 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. | baseline and at 3 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and at 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and at 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | kg/m^2 | baseline 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | baseline and at 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and at 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and at 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and at 3 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D004700 | Endocrine System Diseases |