Trial Outcomes & Findings for Online Diabetes Education Project (ODEP) (NCT NCT04743778)

Results Overview

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%.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

baseline and at 3 months

Results posted on

2024-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Online Diabetes Education Project (ODEP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Diabetes Self-Management Education and Support n=12 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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%.

Outcome measures

Outcome measures
Measure	Virtual Diabetes Self-Management Education and Support n=12 Participants 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.
Metabolic Control of A1c (Mean Change in A1C)	-0.02 percent Standard Deviation 1.64

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Diabetes Self-Management Education and Support n=12 Participants 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.
Depression	-0.79 units on a scale Standard Deviation 4.14

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Diabetes Self-Management Education and Support n=12 Participants 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.
Regimen Adherence	1.12 units on a scale Standard Deviation 4.01

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Diabetes Self-Management Education and Support n=12 Participants 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.
Body Mass Index (BMI)	-0.54 kg/m^2 Standard Deviation 10.34

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Diabetes Self-Management Education and Support n=12 Participants 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.
Blood Pressure Systolic	7.75 mmHg Standard Deviation 14.75
Blood Pressure Diastolic	5.33 mmHg Standard Deviation 10.76

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Diabetes Self-Management Education and Support n=12 Participants 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.
Diabetes Social Support	0.48 units on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Diabetes Self-Management Education and Support n=12 Participants 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.
Diabetes-Related Distress	-5.72 units on a scale Standard Deviation 14.46

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Diabetes Self-Management Education and Support n=12 Participants 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.
Diabetes Quality of Life	0.14 units on a scale Standard Deviation 0.65

Adverse Events

Virtual Diabetes Self-Management Education and Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jaclynn Hawkins

University of Michigan, School of Social Work

Phone: (734) 615-2817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place