Preventative MedicineNCT05676970
Using a Telehealth and Shared Decision-Making Model to Address Preventative Medicine Strategies Among Communities in Louisiana
A study testing Telehealth: Personalized Preventative Medicine Strategies and TeleHealth: Preventative Medicine Education in people with Preventative Medicine, run by Xavier University of Louisiana. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Preventative Medicine
- What is being tested?
- Telehealth: Personalized Preventative Medicine Strategies and TeleHealth: Preventative Medicine Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 1. Individuals who are unable to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Xavier University of Louisiana
New Orleans, Louisiana, 70125
Sara Al-Dahir, PhD, 504-520-5766, saaldah@xula.edu
PhD
About this study
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.
Read the 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.
- Conditions
- Preventative Medicine
- Being tested
- Telehealth: Personalized Preventative Medicine Strategies, TeleHealth: Preventative Medicine Education
- Keywords
- Diabetes, Hypertension, Hyperlipidemia, Medication Compliance, Nutrition, Exercise
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperlipidemias, Medication Adherence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth: Personalized Preventative Medicine StrategiesBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TeleHealth: Preventative Medicine Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Monthly through study completion, on average, 12-18 months
Secondary outcomes (4)
Barriers to preventative medicine strategies
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.
Measured: Through study completion, on average, 12-18 months
Knowledge of personal disease risk (diabetes, hypertension, hyperlipidemia) using standardized education tools
10 question knowledge test, Scored as minimally competent at 70% correct, scored as binary
Measured: 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
10 question knowledge test, Scored as minimally competent at 70% correct, scored as binary
Measured: 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
10 question knowledge test, Scored as minimally competent at 70% correct, scored as binary
Measured: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jan 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventative MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xavier University of Louisiana.
- Sponsor type
- University, hospital or other
- Collaborators
- Elaine P Nunez Community College
- Responsible party
- Sponsor
- Investigators
- Sara Al-Dahir, PhD, Principal investigator, Xavier University of Louisiana.Klaus Heyer, PhD, Principal investigator, Nunez Community College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676970
- Sponsor's protocol ID
- IRB938-24
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2022
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, we will share our intervention and information below.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Telehealth and Shared Decision-Making Model to Address Preventative Medicine Strategies Among Communities in Louisiana
- ClinicalTrials.gov ID
- NCT05676970
- Acronym / sponsor ID
- IRB938-24
- Conditions
- Preventative Medicine
- Keywords
- Diabetes, Hypertension, Hyperlipidemia, Medication Compliance, Nutrition, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Xavier University of Louisiana.University, hospital or other
- Collaborators
- Elaine P Nunez Community College
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telehealth Arm: Personalized Preventative Medicine Strategies | Experimental | Behavioral: Telehealth: Personalized Preventative Medicine StrategiesIndividuals 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 | Active comparator | Behavioral: TeleHealth: Preventative Medicine EducationIndividuals 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Individuals who are unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth: Personalized Preventative Medicine StrategiesIndividuals 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. | Behavioural | Telehealth Arm: Personalized Preventative Medicine Strategies |
| TeleHealth: Preventative Medicine EducationIndividuals 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. | Behavioural | Telehealth Arm: Preventative Medicine Education |
Primary outcome
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)
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
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)
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
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
4 secondary outcomes
Barriers to preventative medicine strategies
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes. Upon request, we will share our intervention and information below.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Al-Dahir, PhD principal investigator
Xavier University of Louisiana.
Klaus Heyer, PhD principal investigator
Nunez Community College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth: Personalized Preventative Medicine Strategies and TeleHealth: Preventative Medicine Education in people with Preventative Medicine, run by Xavier University of Louisiana. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Al-Dahir, PharmD, PhD (5045205766, saaldah@xula.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to participate in preventative medicine screening for Diabetes, Hypertension and Hyperlipidemia (time frame: 12 months, completed year 1 of the study.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.