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NCT Number: NCT05676970

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

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Key information

Conditions

Preventative Medicine Behavior Cardiovascular Diseases Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Hyperlipidemias Hypertension Lipid Metabolism Disorders Medication Adherence Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xavier University of Louisiana

New Orleans, Louisiana, 70125, United States

Location status: Recruiting

Location contact

PhD

CONTACT

Sara Al-Dahir, PhD

CONTACT

[email protected]

504-520-5766

Sara Al-Dahir, PharmD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Individuals who are unable to give informed consent.

Treatment and study plan

Telehealth: Personalized Preventative Medicine Strategies

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: Preventative Medicine Education

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.

Primary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Hamed, BSc

CONTACT

[email protected]

5045204537

Sara Al-Dahir, PharmD, PhD

CONTACT

[email protected]

5045205766

Sponsors and collaborators

Lead sponsor

Xavier University of Louisiana.

Other

Collaborators

  • Elaine P Nunez Community College

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 9, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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