Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study

First, we will conduct ethnographic research with community leaders, health aides, and
residents to identify local knowledge and cultural values and concerns related to healthcare
access and delivery.

Next, 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.

A computer-generated stratified random assignment program, held by Dr. Delucchi, will
individually randomize participants based on their village size (>400 residents), cigarettes
per day (>8), and stage of change, the last two variables known to be related to outcomes
and addressed by the intervention. Participants will be randomized after providing baseline
biosamples at their village clinic and completing the baseline phone assessment. Staff will
be unaware of the next group assignment.

Intervention Components and Study Conditions. Treatment components are informed by our
experience with intervening on tobacco and other behavioral risks, the broader research
literature, and our team's 6-year CBPR in Alaska. Both groups will receive active
interventions with behavioral counseling at baseline and months 3, 6, and 12. The counseling
is guided by a Transtheoretical Model-tailored computer-assisted program completed
interview-style by the counselor based in Anchorage via teleconference with the study
participant seated with the AN health aide. The systems generate Transtheoretical
Model-tailored, highly individualized reports that will be mailed to participants along with
stage-tailored manuals with strategies for supporting behavioral changes. Pharmacotherapy
will be provided (nicotine replacement for Group 1) or arranged through clinical referral
(statins/HTN meds for Group 2), with counseling for medication compliance. While
intervention components are parallel in format and time demand for the two treatment groups,
the two conditions will differ in their targeted behaviors, which is of central focus to the
aims of the proposed study.

Telehealth Services. The telehealth systems include the TConsult Software Suite: a secure,
web-based platform for creating telehealth cases, capturing data from medical devices,
referring and communicating with others; and AFHCAN Telemedicine Carts: mobile workstations
with power management hardware that allow health care professionals to capture patient
information using electronic forms and integrated biomedical peripherals including a vital
signs monitor, stethoscope, and video conferencing interface, which will be used in the
proposed trial for delivering the behavioral counseling. Community AN health aids, based in
the clinics, will be onsite to facilitate the counseling interaction via the telemedicine
carts. The AN health aids will obtain biosamples and take height and weight measurements and
blood pressure.

Psychosocial Treatment Components:

Transtheoretical Model-Tailored Computer-Assisted Intervention, Personalized Report, &
Manual:

The computer-assisted interventions for tobacco/physical activity and HTN/HC are similar in
structure, format, interface, delivery, and time for completion. The programs' assessment
items and tailored feedback on stage of change, pros/cons of change, self-efficacy, and
change strategies, however, are behavior-specific.

Both programs will be culturally- and regionally-tailored. The computer-assisted
interventions will be "provider-facing," delivered interview-style by the study counselors
with the participants using teleconferencing technology assisted by the AN health aides.
Follow-up reports at 3, 6, and 12 months provide both normative and ipsative feedback; that
is, comparisons are made to the person's previous scores. Repeated expert system contacts
have the potential of engaging patients initially not ready to change.

Designed to support progress with behavioral goals, the Transtheoretical Model-tailored
self-help manuals contain information on the targeted behaviors (tobacco/physical activity,
HTN/HCL+diet), behavior-change guidance following key Transtheoretical Model constructs, and
self-help activities. The HTN/HCL manual focuses on medication adherence for heart health
medications generally with reference to HTN and HCL specifically, and dietary change.

Pharmacotherapy. In Group 1, all smokers interested in quitting will have access to a
12-week course of nicotine patch with gum or lozenge provided by the study. The study
counselor will assess participant interest at each telemedicine contact up until the
12-month follow-up. The approach of allowing participants to engage with cessation services
as they become ready to quit is consistent with Transtheoretical Model and used successfully
in our previous trials.Medication dosing will follow package inserts with adjustments to
address any side effects. Regardless of group, study participants with HTN or HCL will be
referred for medication evaluation with their primary care provider (and/or cardiologist).
Medication adherence, however, is a concern; hence, participants in Group 2 will receive
counseling on HTN/HCL med adherence.

Condition-Specific Components. With the focus on physical activity, Group 1 participants
will receive a pedometer, a booklet for tracking their daily steps, and information and goal
setting for increasing steps by 10% weekly to reach 10,000 steps/day. The focus of the
physical activity intervention will be on building in more lifestyle moderate-to-vigorous
physical activity. The study staff will screen participants with the PAR-Q for the
appropriateness of physical activity and consult with Drs. Benowitz and Schnellbaecher and
make provider referrals as needed.

Group 2 participants will receive a regionally-tailored AN cookbook of heart healthy
recipes; have their blood pressure taken with the telecart by the health aid at each
counseling session; and receive lipid profile feedback at 6-months.

Cross-Condition Contamination. Smoking cessation will not be a focus of the provider
counseling interaction for Group 2 participants. Group 2 participants who are interested in
quitting smoking will be referred to the AK quitline and can purchase NRT at-cost from the
BBAHC health service. Group 1 participants who screen positive for HTN or HCL will be
referred for medication evaluation with their primary care provider (and/or cardiologist).
Through the AN health plan, they will be able to access clinically indicated medications.
Compliance with statins and antihypertensive agents, however, will not be a focus of the
study counseling interaction for group 1 participants.

Process Measures. Multiple process measures will track the extent to which the treatments
are delivered to participants as intended and will be examined as mediators of treatment
outcomes. We will monitor both treatment delivery and cross-condition contamination via
automated systems, participant self-report, and clinician checklists.

Assessment Schedule & Participant Tracking. Assessments will be at baseline and months 3, 6,
12, and 18 conducted via a toll-free phone line at study offices in Anchorage. Biomarker
assays will be conducted at the village clinics. Participants will be paid $30 at baseline;
$40 at months 3, 6, 12; and $50 at 18-months, for total possible stipend of $200 provided
via a debit card. A contact form will collect information for tracking participants. At each
follow-up, changes in contact information are elicited. A computerized database, password
protected on a secure server with firewall will manage participant contacts. Reminder calls
and mailings will be made to participants regarding scheduled assessments.

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