Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study

Study Overview
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Brief Summary
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This study aims to identify effective and cost-effective interventions for tobacco use and other risk behaviors for cardiovascular disease among Alaska Native people in rural villages. In a randomized controlled trial, the study will compare interventions using telemedicine to promote the American Heart Association's identified ideal health behaviors (nonsmoking and physical activity) relative to ideal health factors (managing cholesterol and blood pressure).

Detailed Description
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In an RCT, we will compare 2 active treatments delivered over 12-months via telehealth services linking participants in rural villages to Anchorage and Stanford-based study counselors overcoming access-to-care for CV preventive health issues. The village AN health aides will facilitate data collection and telehealth connectivity. Intervention contacts occur at baseline, 3-, 6- and 12-months follow-up, with the final assessment at 18-months. The repeated intervention contacts provide iterative computerized feedback reflecting prior responses and encouragement of adoption and maintenance of behavioral health goals. The groups are: Tobacco/Physical Activity Intervention (n=150), consisting of a psychosocial component that includes counselor-facing computer-assisted intervention with tailored counseling feedback focused on increasing intrinsic motivation, goal setting for tobacco and physical activity, adherence with nicotine replacement therapy (NRT, patch plus gum or lozenge), and self-monitoring with a pedometer-based walking program. The study will provide 12-weeks of NRT for participants randomized to this intervention condition. HTN/HCL (HTN/HC, n=150), consisting of a psychosocial component that includes counselor-facing computer-assisted intervention with tailored counseling feedback focused on increasing intrinsic motivation, goal setting for managing HTN and HCL, and adherence with antihypertensives and statins with supportive dietary changes. The AN health plan covers antihypertensive and statins as a benefit to patients and would be prescribed as part of standard of care (i.e., not prescribed for the purposes of this research); however, strategies to maximize medication adherence are needed, hence the focus of this intervention. The counseling and print materials are highly individualized, unique to the participant, thereby minimizing the likelihood of cross-condition contamination, determined to be minimal in prior investigations. For the research study, participant eligibility criteria include AN heritage; daily cigarette smoking; and hypertension, hyperlipidemia, or established vascular disease. Intention to change the targeted risk behaviors will not be required to participate. Utilizing telemedicine technology and Transtheoretical Model-tailored interventions, the trial aims to reach at-risk AN people regardless of residential location or current motivation. The primary outcome is biochemically-confirmed tobacco abstinence using anabasine. Secondary outcomes include moderate-to-vigorous physical activity assessed by self-report, blood pressure, cholesterol ratio, medication adherence, dietary change, body mass index, Framingham index, multibehavioral impact factor, a linear index, and cost effectiveness.

Official Title
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Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Behavioral: Tobacco/Physical Activity Intervention
* Behavioral: Diet plus BP/CHOL Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoking > 5 cigarettes/day and > 100 cigarettes in one's lifetime Hypertension, hypercholesterolemia, or established vascular disease Fluent in English language Exclusion Criteria: Dementia or other brain injury Pregnancy or breastfeeding Currently engaged in tobacco treatment or using cessation pharmacotherapy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tobacco/Physical Activity Intervention<br>Includes a psychosocial component that utilizes a counselor-facing computer-assisted intervention with tailored counseling feedback focused on increasing intrinsic motivation, goal setting for tobacco and physical activity, adherence with nicotine replacement therapy, and self-monitoring with a pedometer-based walking program. The intervention will provide 12 weeks of nicotine replacement therapy for participants. | Behavioral: Tobacco/Physical Activity Intervention<br>* Telemedicine stage-tailored counseling intervention focused on increasing intrinsic motivation and goal setting for tobacco and physical activity, adherence with nicotine replacement therapy (NRT, patch plus gum or lozenge), and self-monitoring with a pedometer-based walking program.<br>|
| Experimental: Diet plus BP/CHOL Intervention<br>Consists of a psychosocial component that includes counselor-facing computer-assisted intervention with tailored counseling feedback focused on increasing intrinsic motivation, goal setting for managing hypertension and hypercholesterolemia, and adherence with antihypertensives and statins with supportive dietary changes. The intervention provides a cookbook of heart healthy regional recipes and medication bag for storing medications. | Behavioral: Diet plus BP/CHOL Intervention<br>* Telemedicine stage-tailored counseling intervention focused on increasing intrinsic motivation, goal setting for managing HTN and HCL, and adherence with antihypertensives and statins with supportive dietary changes. Includes a native diet cookbook and medication bag.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Status: 7-day point prevalence abstinence | Change from baseline as no tobacco use, including a puff, in the past 7 days | Assessed at baseline, 3, 6, 12, and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minutes of moderate-to-vigorous physical activity in past 7 days | self-reported minutes of moderate-to-vigorous physical activity | Assessed at baseline, 3, 6, 12, and 18 months | 
| Blood pressure | Measured as systolic/diastolic in mmHg | Assessed at baseline, 3, 6, 12, and 18 months | 
| Total, LDL, and HDL cholesterol | measured in milligrams per deciliter of blood (mg/dL) | Assessed at baseline and 18 months | 
| Body Mass Index (BMI) | weight (in kilograms) over height squared (in centimeters) | Assessed at baseline, 3, 6, 12, and 18 months | 
| Framingham Risk Factor Score | gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual | Assessed at baseline and 18 months | 
| Medication Adherence | self-reported assessment of adherence to BP and CHOL meds | Assessed at baseline, 3, 6, 12 and 18 months | 
| Dietary Quality | culturally tailored FFQ assessing consumption of native and non-native foods | Assessed at baseline, 3, 6, 12 and 18 months | 
| Multiple Risk Behavior Change Impact Factor | intervention efficacy times participation summed over the multiple behavioral targets, I = ∑# of behaviors(n) (En × Pn) | Assessed at baseline, 3, 6, 12 and 18 months | 
| Linear index of multiple behavior change | computed by subtracting baseline scores from follow-up scores for each risk behavior, dividing by the standard deviation of the difference (i.e., z-score), and summing across the individual risks (smoking, exercise, diet, adherence) | Assessed at baseline, 3, 6, 12 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco dependence, Cardiovascular disease, Risk behaviors, Smoking, Physical activity, Alaska Native people