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

February 27, 2026 updated by: Xavier University of Louisiana.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sara Al-Dahir, PharmD, PhD
  • Phone Number: 5045205766
  • Email: saaldah@xula.edu

Study Contact Backup

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70125
        • Recruiting
        • Xavier University of Louisiana
        • Contact:
          • PhD
        • Principal Investigator:
          • Sara Al-Dahir, PharmD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Exclusion Criteria:

1. Individuals who are unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to participate in preventative medicine screening for Diabetes, Hypertension and Hyperlipidemia
Time Frame: 12 months, completed year 1 of the study.
Questionnaire derived from Documented preventative medicine strategies; Ordinal Variable: Scale of 1 to 5 (Least Likely to Most Likely)
12 months, completed year 1 of the study.
Participating in Screening for DM, hypertension, hyperlipidemia
Time Frame: Through study completion, on average, 12-18 months
Participated in preventative medicine screening activity such as fasting blood glucose, blood pressure check and lipid panels. Binary Variable: Yes or No
Through study completion, on average, 12-18 months
Willingness to participate in personalized exercise and nutrition goals to prevent chronic disease
Time Frame: Through study completion, on average, 12-18 months
Questionnaire derived from Documented preventative medicine strategies; Ordinal Variable: Scale of 1 to 5 (Least Likely to Most Likely)
Through study completion, on average, 12-18 months
Participating in personalized exercise and nutrition goals
Time Frame: Monthly through study completion, on average, 12-18 months
After development of personalized exercise and nutrition goals with Telehealth pharmacist, documented participation in activities at least once per week. Data will be recorded monthly as a Binary Variable: Yes or No
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
Time Frame: Monthly through study completion, on average, 12-18 months
After development of personalized exercise and nutrition goals with Telehealth pharmacist, documented participation in activities at least once per week. Data will be recorded monthly as a Binary Variable: Yes or No
Monthly through study completion, on average, 12-18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barriers to preventative medicine strategies
Time Frame: Through study completion, on average, 12-18 months
Work place barriers will be assessed as dichotomized variables such as: insurance access, paid time off for illness, work schedules consistent permitting medical appointments, and medication compliance.
Through study completion, on average, 12-18 months
Knowledge of personal disease risk (diabetes, hypertension, hyperlipidemia) using standardized education tools
Time Frame: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months
10 question knowledge test, Scored as minimally competent at 70% correct, scored as binary
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
Time Frame: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months
10 question knowledge test, Scored as minimally competent at 70% correct, scored as binary
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
Time Frame: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months
10 question knowledge test, Scored as minimally competent at 70% correct, scored as binary
Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xavier University of Louisiana.

Collaborators

Elaine P Nunez Community College

Investigators

  • Principal Investigator: Klaus Heyer, PhD, Nunez Community College
  • Principal Investigator: Sara Al-Dahir, PhD, Xavier University of Louisiana.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB938-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request, we will share our intervention and information below.

IPD Sharing Time Frame

After completion of study.

IPD Sharing Access Criteria

Approval by Principal Investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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