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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorXavier University of Louisiana.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Telehealth Arm: Personalized Preventative Medicine StrategiesExperimental treatment 1 intervention
Group B: Telehealth Arm: Preventative Medicine EducationActive comparator 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xavier University of Louisiana.

Lead sponsor

Elaine P Nunez Community College

Collaborator