Using a Telehealth and Shared Decision-Making Model to Address Preventative Medicine Strategies Among Communities in Louisiana

Обзор

This study is a 12-18 month behavioral intervention study to assess the impact of enrolling individuals a clinical pharmacist run Telehealth education focused on wellness and preventive health strategies. Individuals will be randomized to either a wellness education only model focusing on nutrition, diabetes, hyperlipidemia and hypertension or a wellness education model with personalized preventative medicine strategies for the patient. All participants will complete individual and group based interventions. Individuals will be recruited from target work industries such as health workers, teachers aides and the food industry. We are recruiting individuals who come from urban, semi-rural or rural communities or have additional social determinants of health that indicate social vulnerability. The primary outcome is willingness to participate in preventative medicine strategies to prevent development of chronic medical conditions. The secondary outcome is barriers to preventive medicine strategies including for chronic preventable disease such as nutrition, hypertension, hyperlipidemia, diabetes and medication compliance.

Подробное описание

Individuals will be recruited using a community-based participatory research model to identify 360 patients to enter into an 12-18 month clinical pharmacist run, preventative medicine strategies including; health and wellness program delivered via Xavier's clinical pharmacy faculty trained in telehealth medicine using an individually randomized group treatment trial approach based upon industry of recruitment. Participants will be recruited from target high risk industries for respiratory infection: hospitality and food industry, plant workers, nurse's aides, teacher's aides and the beauty industries. Participants will complete a minimum of three individual visits and group informational visits with a target of five sessions total. Both arms of the study will receive health and wellness education around target topics of diabetes, hypertension, hyperlipidemia, nutrition, exercise, herbals and medication compliance. Only the preventative medicine education intervention arm will receive the preventative medicine education including personalized counseling around the target disease states, medication reviews, medication-nutrition reviews and development of a personalized plan. Measures in changes in preventative health behaviors will occur by the clinical pharmacist via patient interviews. The primary outcome will be preventative medicine strategies knowledge preventable chronic diseases such as diabetes, hypertension and hyperlipidemia. The secondary outcome will be assessing barriers for preventive health behaviors.

Impact: The implications of this proposed project are to understand health related beliefs and behaviors related to preventative medicine strategies in the context of a general health and wellness model.

Вмешательства

• Поведенческое Telehealth: Personalized Preventative Medicine Strategies
  Individuals in this arm will complete a personalized telehealth interventions that focus on nutrition, work-life balance, medication compliance, herbals, exercise targets hyperlipidemia, diabetes and hypertension around individual risks for development of the disease state. All educations will be completed one-on-one as well as small group.
• Поведенческое TeleHealth: Preventative Medicine Education
  Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension general education. All educations will be completed one-on-one as well as small group.

Первичные конечные точки

• Willingness to participate in preventative medicine screening for Diabetes, Hypertension and Hyperlipidemia [Срок оценки: 12 months, completed year 1 of the study.]
• Participating in Screening for DM, hypertension, hyperlipidemia [Срок оценки: Through study completion, on average, 12-18 months]
• Willingness to participate in personalized exercise and nutrition goals to prevent chronic disease [Срок оценки: Through study completion, on average, 12-18 months]
• Participating in personalized exercise and nutrition goals [Срок оценки: Monthly through study completion, on average, 12-18 months]
• Participating in personalized medication compliance for prescription, over the counter, herbals and nutraceuticals related to health promotion [Срок оценки: Monthly through study completion, on average, 12-18 months]

Вторичные конечные точки (4)

• Barriers to preventative medicine strategies [Срок оценки: Through study completion, on average, 12-18 months]
• Knowledge of personal disease risk (diabetes, hypertension, hyperlipidemia) using standardized education tools [Срок оценки: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months]
• Knowledge of risk factors and personal risk for diabetes, hypertension and hyperlipidemia [Срок оценки: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months]
• Knowledge of personalized medication compliance for prescription, over the counter, herbals and nutraceuticals related to health promotion [Срок оценки: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months]

Критерии участия

Критерии включения

• Adults aged 18 years to 55 years of age
• Able to speak English
• Currently employed or seeking training in target industries such as: healthcare, education, beauty, hospitality, food (culinary) and industrial plant workers.
• Able to use Telehealth technology via tablet, cell phone, or computer

Критерии исключения

1\. Individuals who are unable to give informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Xavier University of Louisiana — New Orleans

Идентификаторы

NCT: NCT05676970 · IRB938-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗