Diabetes Mellitus, Type 2ODEPNCT04743778
Online Diabetes Education Project (ODEP)
A study testing Virtual Diabetes Self-Management Education and Support in people with Diabetes Mellitus, Type 2, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Virtual Diabetes Self-Management Education and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agee 18 or older, Black, a diagnosis of T2D for one year duration or longer, ambulatory status.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Diabetes Education Project: Virtual Diabetes Self-Management Education and Support Intervention
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Virtual Diabetes Self-Management Education and Support
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Diabetes Self-Management Education and SupportBehavioural
Diabetes self-management education and support delivered through Zoom for health.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Diabetes Self-Management Education and Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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.
Measured: baseline and at 3 months
Secondary outcomes (5)
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.
Measured: baseline 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Aug 2021
- Primary completion20 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaclynn Hawkins, University of Michigan
- Investigators
- Jaclynn Hawkins, MSW, PhD, Principal investigator, University of Michigan, School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743778
- Sponsor's protocol ID
- ODEP HUM00190508
- Other IDs
- P30DK092926
- Acronym
- ODEP
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2021
- Last updated
- 7 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Diabetes Education Project: Virtual Diabetes Self-Management Education and Support Intervention
- ClinicalTrials.gov ID
- NCT04743778
- Acronym / sponsor ID
- ODEP / ODEP HUM00190508
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Posted 7 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Diabetes Self-Management Education and Support | Experimental | Behavioral: Virtual Diabetes Self-Management Education and SupportParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Agee 18 or older, Black, a diagnosis of T2D for one year duration or longer, ambulatory status.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Diabetes Self-Management Education and SupportDiabetes self-management education and support delivered through Zoom for health. | Behavioural | Virtual Diabetes Self-Management Education and Support |
Primary outcome
Metabolic Control of A1c (Mean Change in A1C)
Time frame: 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%.
Depression
Time frame: 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.
Regimen Adherence
Time frame: 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.
5 secondary outcomes
Body Mass Index (BMI)
Time frame: baseline 3 months
Blood Pressure
Time frame: baseline and at 3 months
Diabetes Social Support
Time frame: baseline and at 3 months
Diabetes-Related Distress
Time frame: baseline and at 3 months
Diabetes Quality of Life
Time frame: baseline and at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclynn Hawkins, MSW, PhD principal investigator
University of Michigan, School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Diabetes Self-Management Education and Support in people with Diabetes Mellitus, Type 2, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Control of A1c (Mean Change in A1C) (time frame: baseline and at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.