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

NCT05676970 | Recruiting DMC

• 1 other identifier: IRB938-24
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Preventative Medicine

Keywords

Diabetes; Hypertension; Hyperlipidemia; Medication Compliance; Nutrition; Exercise

Outcome Measures

Primary Outcomes (5)

• Willingness to participate in preventative medicine screening for Diabetes, Hypertension and Hyperlipidemia

  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

  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

  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

  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

  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 Outcomes (4)

• Barriers to preventative medicine strategies

  Through study completion, on average, 12-18 months

• 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

• 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

• 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

Study Arms (2)

Telehealth Arm: Personalized Preventative Medicine Strategies

EXPERIMENTAL

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

Telehealth Arm: Preventative Medicine Education

ACTIVE COMPARATOR

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

Interventions

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.

Telehealth Arm: Preventative Medicine Education

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 Arm: Personalized Preventative Medicine Strategies

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Xavier University of Louisiana.: lead
• Elaine P Nunez Community College: collaborator

Study Sites (1)

Xavier University of Louisiana

New Orleans, Louisiana, 70125, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemias; Medication Adherence; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sara Al-Dahir, PhD

  Xavier University of Louisiana.

  PRINCIPAL INVESTIGATOR

• Klaus Heyer, PhD

  Nunez Community College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Al-Dahir, PharmD, PhD

CONTACT

5045205766; saaldah@xula.edu

Ibrahim Hamed, BSc

CONTACT

5045204537; ihamed@xula.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 9, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of study.
• Access Criteria: Approval by Principal Investigator.

Locations

US (1)