Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Remote Patient Monitoring in a Faith-Based Program, Traditional Cohort Faith-based DSMES program.
- Кому может быть актуально
- Состояния в реестре: Blood Cholesterol, Blood Pressure Monitoring, Weight Change, BMI. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City: A Pilot Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Remote Patient Monitoring in a Faith-Based Program
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 - Поведенческое Traditional Cohort Faith-based DSMES program
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.
Первичные конечные точки
- Change from Baseline in HbA1C results at 12 weeks [Срок оценки: From enrollment to end of treatment at 12 weeks]
Вторичные конечные точки (8)
- Change from Baseline in BMI at 12 weeks [Срок оценки: From enrollment to end of treatment at 12 weeks]
- Change from Baseline in systolic blood pressure at 12 weeks [Срок оценки: From baseline to the end of treatment at 12 weeks]
- Change from Baseline in Diastolic Blood Pressure at 12 weeks [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Change from Baseline in Total Cholesterol at 12 weeks [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at 12 weeks [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at 12 weeks [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Change from Baseline in Triglycerides at 12 weeks [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Change from Baseline in Body Weight at 12 weeks [Срок оценки: From enrollment to the end of treatment at 12 weeks]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Not a resident of Jefferson County, Alabama
- Completed a DSMES program
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- New Hope Baptist Church — Birmingham
Идентификаторы
NCT: NCT07556354 · IRB-300015932 · P50MD017338