Clinical trial NCT02137902: Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study
Official title: Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Tobacco dependence
Cardiovascular disease
Risk behaviors
Smoking
Physical activity
Alaska Native people
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Alaska Native Tribal Health Consortium
name: University of Alaska Anchorage
name: Norton Sound Health Corporation
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-05-14
Enrollment: 299
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Status: 7-day point prevalence abstinence
timeFrame: Assessed at baseline, 3, 6, 12, and 18 months
Secondary outcomes:
measure: Minutes of moderate-to-vigorous physical activity in past 7 days
timeFrame: Assessed at baseline, 3, 6, 12, and 18 months
measure: Blood pressure
timeFrame: Assessed at baseline, 3, 6, 12, and 18 months
measure: Total, LDL, and HDL cholesterol
timeFrame: Assessed at baseline and 18 months
measure: Body Mass Index (BMI)
timeFrame: Assessed at baseline, 3, 6, 12, and 18 months
measure: Framingham Risk Factor Score
timeFrame: Assessed at baseline and 18 months
measure: Medication Adherence
timeFrame: Assessed at baseline, 3, 6, 12 and 18 months
measure: Dietary Quality
timeFrame: Assessed at baseline, 3, 6, 12 and 18 months
measure: Multiple Risk Behavior Change Impact Factor
timeFrame: Assessed at baseline, 3, 6, 12 and 18 months
measure: Linear index of multiple behavior change
timeFrame: Assessed at baseline, 3, 6, 12 and 18 months
Other outcomes:
Locations:
city: Nome
country: United States
facility: Norton Sound Health Corporation
state: Alaska
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Judith J Prochaska, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prochaska JJ, Benowitz NL. The Past, Present, and Future of Nicotine Addiction Therapy. Annu Rev Med. 2016;67:467-86. doi: 10.1146/annurev-med-111314-033712. Epub 2015 Aug 26.
citation: Prochaska JJ, Benowitz NL. Smoking cessation and the cardiovascular patient. Curr Opin Cardiol. 2015 Sep;30(5):506-11. doi: 10.1097/HCO.0000000000000204.
citation: Prochaska JJ, Epperson A, Skan J, Oppezzo M, Barnett P, Delucchi K, Schnellbaecher M, Benowitz NL. The Healing and Empowering Alaskan Lives Toward Healthy-Hearts (HEALTHH) Project: Study protocol for a randomized controlled trial of an intervention for tobacco use and other cardiovascular risk behaviors for Alaska Native People. Contemp Clin Trials. 2018 Aug;71:40-46. doi: 10.1016/j.cct.2018.06.003. Epub 2018 Jun 2.