Reducing Health Disparities in Appalachians with Multiple Cardiovascular Disease Risk Factors Wayne Noble, Clinical Research Protocol Manager Debra Moser, Professor and Linda C Gill Chair of Cardiovascular Nursing @DebraMoser dmoser@uky.edu
Wayne Noble and Debra Moser • Have nothing to disclose. 2
Acknowledgements • Patient Centered Outcomes Research Institute • Community members and other stakeholders • Advisory Board • Center for Excellence in Rural Health-Hazard
CVD Health Disparities and Appalachia • Appalachian Kentucky is in the top 1% of the nation in cardiovascular disease (CVD) morbidity and mortality • Individuals in Appalachian Kentucky have the highest rates of multiple CVD risk factors seen in any state • Problem amplified by the distressed environment • County with the worst life expectancy in the U.S. • Of 13 counties in the U.S with a decreased life expectancy (1980 to 2014), 8 are in Appalachian Kentucky • Among the poorest counties in the U.S. • There is a critical need to test sustainable CVD risk reducing interventions appropriate for Appalachia
Approach • Lifestyle interventions can reduce CVD risk by 44% • Lifestyle change is most effective when patients are given the tools to engage in self-care • interventions individualized to patients’ needs and barriers are more effective than interventions that are not • Our central hypothesis was that to be successful in socioeconomically austere environments, CVD risk reducing interventions must focus on lifestyle change that increases individuals’ abilities to engage in self-care, be culturally appropriate, and have components that overcome barriers in such environments.
Community-Engaged Research Patient and Other Stakeholder Engagement • Focus groups with community members, people in target population, care providers, community leaders, business people prior and after study • Advisory board composed of members of these groups • Advisory board members on the grant • Advisory board members attend the monthly research meetings • Successes, problems, barriers • Equal members • Staff, community health workers (CHW) from community of focus
Specific Aims 1.Compare 4 month (short-term) and 1 year (long-term) impact on CVD risk factors selected by patients (i.e., tobacco use, blood pressure, lipid profile, HgA1c for diabetics, body mass index, depressive symptoms, or physical activity level) 2.all CVD risk factors 3.quality of life 4.patient satisfaction 5.desirability and adoptability by assessing adherence to recommended CVD risk reduction protocols, and retention of recruited individuals
Design • 2 group randomized controlled comparative effectiveness trial Study Design
Inclusion Criteria • Do not have primary care provider or haven’t seen one > 1 year • At risk for CVD as reflected by having two or more: 1. diagnosis of hypertension or taking medications diagnosed for hypertension or found to be hypertensive by us 2. diagnosis of hyperlipidemia or taking medication for treating abnormal lipid levels, or any lipid abnormality found on our screening 3. diagnosis of type 2 diabetes or HgA1c > 7% found on our screening 4. overweight or obese (body mass index ≥ 25 kg/m 2 ) 5. clinical diagnosis of depression, on medications for depression or found to have depressive symptoms (score of > 9 on the PHQ-9) on our screening 6. sedentary lifestyle; individual does not engage in at least 30 minutes of moderate activity for at least 4 days per week 7. diet high in saturated fats and low in fruits and vegetables
Recruitment and Setting • Community health workers • Advertising in local newspapers and gazettes • Advertising at local churches, community centers, agricultural extension offices, senior centers, local business organizations, public health departments, public fairs of all types, county court houses, beauty shops and barbers, convenience stores, gas stations, and drug stores • Advertising on the local radio and television stations that have a specific time set aside for local happenings • Word of mouth • Data collection and intervention at Center for Excellence in Rural Health- Hazard sites
Oversight • IRB approval – everyone who comes in contact with clients received Human Subject training • CHW and our research staff = team who do all aspects of protocol together • Members of the team trained together in all aspects of measurement, protocol maintenance and fidelity to the protocol • All staff performing data collection trained and certified by the PI and other expert clinician-researcher team members • Fidelity assured by oversight, review of recruitment and intervention activities • Monthly team meetings in which protocol and data overviews done
Interventions • Standard of care • Secure an appointment with a primary care provider • all individuals enrolled in the study received referral to a primary care provider for management of the CVD risk factors identified in our screening • free or at a low cost depending on the resources of the patient • did not otherwise influence the delivery of care
HeartHealth Intervention • Delivered over 12-weeks by community • 6 interactive modules: health workers to groups of 10 people using 1) principles self-care, CVD risk reduction; specific behavior change principles 2) nutrition (portion control, diet high in • Whole health approach fruits and vegetable and whole grains, reducing saturated and trans fats, reducing • Promotion of self-care of CVD risk factors sodium intake, reducing total fat intake, • Skill-based good fats vs bad fats); • Individualized 3) physical activity; 4) depression control and stress reduction; • Culturally sensitive 5) managing multiple comorbid risk factors; 6) smoking cessation and/or medication adherence
Summary of Study Measures Endpoint Measure When Measured Screening Prior to enrollment - cognitive function - Mini-Cog Specific Aims 1 and 2 Baseline, 4 months, 1 year - blood pressure - AHA guidelines - lipid profile - Cholestech POC - body mass index - Height and weight - HgA1c - Bayer POC - depressive symptoms - PHQ-9 - physical activity - Jawbone Specific Aim 3 Baseline, 4 months, 1 year - quality of life - SF-36 version2 Specific Aim 4 4 months, 1 year - patient satisfaction - Patient care delivery satisfaction questionnaire Specific Aim 5 - desirability and adoptability - Adherence to CVD risk reducing Baseline, 4 months, 1 year recommendations assessed by Medical Outcomes Study Specific Adherence Scale 4 months, 1 year - Patient retention
Flow Through the Study
Baseline Participant Characteristics Compared Between Intervention and Control Total Sample Control Intervention P (N=352) (n=168) (n=184) N (%) or N (%) or N (%) or mean + SD mean + SD mean + SD Age, years 42.9 + 12.8 43.2 + 12.2 42.6 + 13.4 .652 Female gender 272 (77.3) 126 (75.0) 146 (79.3) .331 Caucasian ethnicity 338 (96.8) 158 (94.6) 180 (98.9) .022 Education, years 13.6 + 2.8 13.5 + 2.7 13.6 + 2.9 .607 Married, cohabitating 210 (60.2) 103 (61.7) 107 (58.8) .582 Yrs lived in Kentucky 39.2 + 13.9 39.3 + 13.8 39.1+14.2 .896 Financial stability .185 Comfortable 45 (12.9) 21 (12.6) 24 (13.2) Make ends meet 213 (61.0) 95 (56.9) 118 (64.8) Not enough 91 (26.1) 51 (30.5) 40 (22.0)
Total Sample Control Intervention P (N=352) (n=168) (n=184) N (%) or N (%) or N (%) or mean + SD mean + SD mean + SD Charlson comorbidity score .39 + .86 .35 + .72 .42 + .98 .489 Adequate health literacy 270 (78%) 125 (76.2) 145 (79.7) .439 Smoker (based on urinary cotinine) 147 (41.8) 76 (45.2) 71 (38.6) .206 Body mass index, kg/m 2 31.9 + 7.6 31 + 7 32 +8 .169 Framingham risk score, % 9.3 + 8.8 9.4 + 8.7 9.3 + 8.8 .872 Systolic blood pressure, mmHg 137.9 + 19.9 137.8 + 21.3 138.1 + 18.7 .885 Diastolic blood pressure, mmHg 88.3 + 14.7 88.7 +13.9 87.9 + 15.4 .600 Total cholesterol, mg/dL 188.6 + 43.2 185.7 + 41.0 191.3 + 45.1 .227 Low density lipoprotein, mg/dL 105.6 + 33.1 103.7 + 32.5 107.3 + 33.7 .333 High density lipoprotein, mg/dL 46.2 + 14.3 46.4 +14.8 46.1+ 13.9 .869 Triglycerides, mg/dL 187.6 + 121.1 184 + 121 191 +122 .603 Depression score 5.5 + 5.5 5.5 + 5.2 5.5 + 5.8 .966
Percentage of Participants Meeting CVD Risk Reduction Goals
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