Preventative Medicine
Conditions
Keywords
Diabetes, Hypertension, Hyperlipidemia, Medication Compliance, Nutrition, Exercise
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.
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.
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.
Sponsors
Xavier University of Louisiana.
Elaine P Nunez Community College
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
1\. Individuals who are unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Willingness to participate in preventative medicine screening for Diabetes, Hypertension and Hyperlipidemia | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Barriers to preventative medicine strategies | 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. |
| 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 | 10 question knowledge test, Scored as minimally competent at 70% correct, scored as binary |
| 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 | 10 question knowledge test, Scored as minimally competent at 70% correct, scored as binary |
| 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 | 10 question knowledge test, Scored as minimally competent at 70% correct, scored as binary |
Countries
United States
Contacts
CONTACTSara Al-Dahir, PharmD, PhD
CONTACTIbrahim Hamed, BSc
PRINCIPAL_INVESTIGATORSara Al-Dahir, PhD
Xavier University of Louisiana.
PRINCIPAL_INVESTIGATORKlaus Heyer, PhD
Nunez Community College
Outcome results
None listed