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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-29

Study Completion Date

2028-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preventative Medicine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

We propose to use a individually randomized group treatment trial design with a baseline survey to assess social determinants of health, baseline demographic information and preventive medicine strategies. We will then randomize participants in a 1:1 fashion to a personalized preventative medicine intervention arm and a control arm. Given this is an IRGT (Individualized Randomized Group Treatment) trial design, a priori matching should assist in preventing a Type I error. Individuals will then complete 5 individual or group based behavioral health interventions via a Telehealth model conducted by a Clinical Pharmacist.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Telehealth Arm: 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.

Group Type EXPERIMENTAL

Telehealth: Personalized Preventative Medicine Strategies

Intervention Type BEHAVIORAL

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.

Telehealth Arm: 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.

Group Type ACTIVE_COMPARATOR

TeleHealth: Preventative Medicine Education

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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