Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Have a prior diabetes (Type 1, Type 2, or Gestational) or prediabetes diagnosis

Are aged 18 or older

Live in Jefferson County, Alabama

Have never participated in a DSMES program

Disqualifiers

Not a resident of Jefferson County, Alabama

Completed a DSMES program

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote Patient Monitoring in a Faith-Based Program

    Behavioral

    Participants will be randomly-assigned to one of two cohorts. One cohort will participate in a faith-based DSMES program and use remote patient monitoring (RPM) to track their health throughout the duration. Remote patient monitoring allows a participant's healthcare team to visualize and monitor health data outside of scheduled DSMES sessions. These participants will be given blood pressure and blood glucose tracking devices that utilize Bluetooth to automatically upload their health data into an RPM platform, Prevounce, once measurements are taken.

  • Traditional Cohort Faith-based DSMES program

    Behavioral

    The Traditional Cohort will also participate in the DSMES program but instead will be provided traditional blood pressure cuffs and glucometers that will not upload their data to a mobile platform to track their health data. These participants will use traditional means (paper trackers) to track their health data and will provide health updates during scheduled communication with community health workers.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Traditional CohortActive comparator 1 intervention
Group B: Remote Patient Monitoring (RPM) CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in HbA1C results at 12 weeks

HbA1C provides a person's average blood sugar over a 3 month period and will be measured at baseline and the end of the program via fingerprick test. The range of the test is from 4% to 14%. Normal ranges are from 4 to 5.6%, Prediabetes ranges are from 5.7% to 6.4%, Diabetes ranges are from 6.5% and above.

Time frame
From enrollment to end of treatment at 12 weeks

Secondary outcomes

1

Change from Baseline in BMI at 12 weeks

BMI is a screening tool that uses a person's height and weight to estimate their body fat and overall health risk. BMI will be calculated using the participant's height and weight data at baseline and end of program.

Time frame
From enrollment to end of treatment at 12 weeks
2

Change from Baseline in systolic blood pressure at 12 weeks

Systolic blood pressure measures the force against artery walls when the heart contracts, with a normal reading below 120 mmHg. The change in this outcome will be measured via blood pressure cuff pre- and post-.

Time frame
From baseline to the end of treatment at 12 weeks
3

Change from Baseline in Diastolic Blood Pressure at 12 weeks

Diastolic blood pressure measures arterial pressure when the heart rests between beats and will be assessed via blood pressure cuff reading at baseline and end of program. A normal reading is less than 80 mmHg.

Time frame
From enrollment to the end of treatment at 12 weeks
4

Change from Baseline in Total Cholesterol at 12 weeks

Total cholesterol measures the overall amount of cholesterol in the blood and will be assessed via blood sample at baseline and end of program. A desirable level is less than 200 mg/dL.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

1

Change in Diabetes Self-management Behaviors at Baseline and 12 weeks

Diabetes Self-Management Behaviors will be assessed using the Diabetes Self-Management Questionnaire-Revised at Baseline and 12 weeks. Scores are calculated on a scale of 0-10 for the total score. Scores less than 5 for any of the measure's subcales suggest a need for improvement in the respective area (e.g. eating behavior, medication taking, glucose monitoring, physical activity, and cooperation with diabetes care team).

Time frame
From enrollment to the end of treatment at 12 weeks
2

Change in Diabetes Knowledge from Baseline and 12 weeks

Diabetes Knowledge will be assessed from Baseline to 12 weeks utilizing the Diabetes Knowledge Questionnaire-Revised. The diabetes knowledge questionnaire revised is scored from 0-22 with higher scores indicating higher diabetes knowledge and lesser scores indicating lesser diabetes knowledge. There is not an official cutoff criteria for the scores reported.

Time frame
From enrollment to the end of treatment at 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator