Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Behavioral: Diet plus BP/CHOL Intervention; Behavioral: Tobacco/Physical Activity Intervention

• Registration Number: NCT02137902
• Lead Sponsor: Stanford University

Brief Summary

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

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:

1. 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.

2. 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.

Study Timeline

• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Study Start: 2015-06-01
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

• Smoking > 5 cigarettes/day and > 100 cigarettes in one's lifetime
• Hypertension, hypercholesterolemia, or established vascular disease
• Fluent in English language

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Exclusion Criteria

• Dementia or other brain injury
• Pregnancy or breastfeeding
• Currently engaged in tobacco treatment or using cessation pharmacotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet plus BP/CHOL Intervention	Diet plus BP/CHOL Intervention	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.
Tobacco/Physical Activity Intervention	Tobacco/Physical Activity Intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Linear index of multiple behavior change	Assessed at baseline, 3, 6, 12 and 18 months	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)
Multiple Risk Behavior Change Impact Factor	Assessed at baseline, 3, 6, 12 and 18 months	intervention efficacy times participation summed over the multiple behavioral targets, I = ∑# of behaviors(n) (En × Pn)
Minutes of moderate-to-vigorous physical activity in past 7 days	Assessed at baseline, 3, 6, 12, and 18 months	self-reported minutes of moderate-to-vigorous physical activity
Blood pressure	Assessed at baseline, 3, 6, 12, and 18 months	Measured as systolic/diastolic in mmHg
Total, LDL, and HDL cholesterol	Assessed at baseline and 18 months	measured in milligrams per deciliter of blood (mg/dL)
Body Mass Index (BMI)	Assessed at baseline, 3, 6, 12, and 18 months	weight (in kilograms) over height squared (in centimeters)
Framingham Risk Factor Score	Assessed at baseline and 18 months	gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual
Medication Adherence	Assessed at baseline, 3, 6, 12 and 18 months	self-reported assessment of adherence to BP and CHOL meds
Dietary Quality	Assessed at baseline, 3, 6, 12 and 18 months	culturally tailored FFQ assessing consumption of native and non-native foods

Trial Locations

Locations (2)

Norton Sound Health Corporation; 🇺🇸 Nome, Alaska, United States

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States