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RecruitingNCT05676970Updated Mar 3, 2026

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

An interventional study of Telehealth: Personalized Preventative Medicine Strategies and TeleHealth: Preventative Medicine Education in Preventative Medicine, sponsored by Xavier University of Louisiana.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Xavier University of Louisiana. · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Preventative Medicine

Keywords

  • Diabetes
  • Hypertension
  • Hyperlipidemia
  • Medication Compliance
  • Nutrition
  • Exercise
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's planned enrollment of 360 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Xavier University of Louisiana. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

1. Individuals who are unable to give .

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralTelehealth: 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.

  • BehavioralTeleHealth: 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12 months, completed year 1 of the study.

  2. 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

    Time frame: Through study completion, on average, 12-18 months

  3. 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)

    Time frame: Through study completion, on average, 12-18 months

  4. 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

    Time frame: Monthly through study completion, on average, 12-18 months

  5. 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

    Time frame: Monthly through study completion, on average, 12-18 months

Secondary outcomes

  1. 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.

    Time frame: Through study completion, on average, 12-18 months

  2. 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

    Time frame: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months

  3. 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

    Time frame: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months

  4. 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

    Time frame: Baseline, after corresponding session, end of program: Through study completion, on average, 12-18 months

07

Study locations

1 of 1 sites recruiting
  • Xavier University of Louisiana
    New Orleans, Louisiana 70125, United States
    Recruiting
    • Sara Al-Dahir, PhD · Contactsaaldah@xula.edu · 504-520-5766
    • PhD · Contact
    • Sara Al-Dahir, PharmD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — Upon request, we will share our intervention and information below.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: After completion of study.

Access criteria: Approval by Principal Investigator.

Data sharing details ↗ · www.xulavoice.com

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Dec 2028, 59 months after the start.

Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 59 months is above that.

Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2022
First posted
Jan 9, 2023
StartActual
Jan 1, 2024
Primary completionEst.
Dec 1, 2028
CompletionEst.
Dec 30, 2028
Last update
Mar 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05676970
Lead sponsor
Xavier University of Louisiana.
Collaborators
Elaine P Nunez Community College
Responsible party
Sponsor
First posted
Jan 9, 2023
Start date
Jan 1, 2024
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Mar 3, 2026

Study contacts

Sara Al-Dahir, PharmD, PhD
Contact
saaldah@xula.edu
5045205766
Ibrahim Hamed, BSc
Contact
ihamed@xula.edu
5045204537
Sara Al-Dahir, PhD
principal investigator · Xavier University of Louisiana.
Klaus Heyer, PhD
principal investigator · Nunez Community College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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