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

Not Applicable

Recruiting

• Conditions: Preventative Medicine

• Registration Number: NCT05676970
• Lead Sponsor: Xavier University of Louisiana.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-27
• Study First Posted: 2023-01-09
• Study Start: 2024-01-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-08
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Willingness to participate in preventative medicine screening for Diabetes, Hypertension and Hyperlipidemia	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)
Participating in Screening for DM, hypertension, hyperlipidemia	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
Willingness to participate in personalized exercise and nutrition goals to prevent chronic disease	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)
Participating in personalized exercise and nutrition goals	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
Participating in personalized medication compliance for prescription, over the counter, herbals and nutraceuticals related to health promotion	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

Secondary Outcome Measures

Name	Time	Method
Barriers to preventative medicine strategies	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.
Knowledge of personal disease risk (diabetes, hypertension, hyperlipidemia) using standardized education tools	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
Knowledge of risk factors and personal risk for diabetes, hypertension and hyperlipidemia	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
Knowledge of personalized medication compliance for prescription, over the counter, herbals and nutraceuticals related to health promotion	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

Trial Locations

Locations (1)

Xavier University of Louisiana; 🇺🇸 New Orleans, Louisiana, United States