NCT Number: NCT07556354
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35211, United States
Location status: Recruiting
Bertha Hidalgo, PhD
PRINCIPAL_INVESTIGATOR
Dashauna Ballard, PhD
PRINCIPAL_INVESTIGATOR
Dashauna M Ballard, PhD
CONTACT
Sabrina Famuyiwa, MPH
CONTACT
Participants in this study will take part in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center. 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, they will complete questionnaires that assess 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 will be collected. This data will also be collected again after the completion of the program. MedsPLUS Consulting are licensed pharmacists skilled in conducting biometric screenings and will assist in the collection of the clinical data. MedsPLUS Consulting will also be responsible for disposing of the biospecimens collected for the study through use of the SHARPS program.
In this study, DSMES participants will be randomly-assigned to one of two cohorts. One cohort will participate in the 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. The second 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 the team. One community health worker (two total) will be assigned to each cohort to monitor the progress of the participants. These community health workers will contact participants outside of scheduled DSMES sessions to assess barriers that may hinder progress.The results of these interactions will be shared with MedsPLUS Consulting and the study team.
As a means of assessing the barriers for implementation for the entire faith-based DSMES program that incorporates RPM, DSMES participants, leadership from the faith-based organization, community health workers, and MedsPLUS Consulting will be asked to participate in focus groups or semi-structured interviews.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: dsmes
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.
Other names: faith based dsmes
Time frame: From enrollment to end of treatment 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
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 baseline to the end of treatment 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 enrollment to the end of treatment 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
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
Low-density lipoprotein (LDL) cholesterol, often referred to as "bad" cholesterol, contributes to plaque buildup in arteries and will be assessed via blood sample at baseline and end of program. An optimal level is less than 100 mg/dL.
Time frame: From enrollment to the end of treatment at 12 weeks
High-density lipoprotein (HDL) cholesterol, often referred to as "good" cholesterol, helps remove excess cholesterol from the bloodstream and will be assessed via blood sample at baseline and end of program. A desirable level is 60 mg/dL or higher.
Time frame: From enrollment to the end of treatment at 12 weeks
Triglycerides measure the amount of fat in the blood and will be assessed via blood sample at baseline and end of program. A normal level is less than 150 mg/dL.
Time frame: From enrollment to the end of treatment at 12 weeks
Body weight measures total body mass and will be assessed using a calibrated scale at baseline and end of program. It is reported in pounds.
Time frame: From enrollment to the end of treatment at 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
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.
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City: A Pilot Study
Acronym: MCPILOTDSMES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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