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.

Judith J Prochaska, Anna Epperson, Jordan Skan, Marily Oppezzo, Paul Barnett, Kevin Delucchi, Matthew Schnellbaecher, Neal L Benowitz

Journal: Contemporary clinical trials 2019;71():40-46

PMID: 29864548

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Abstract

BACKGROUND

Tobacco use and tobacco-related diseases disproportionately affect Alaska Native (AN) people. Using telemedicine, this study aims to identify culturally-tailored, theoretically-driven, efficacious interventions for tobacco use and other cardiovascular disease (CVD) risk behaviors among AN people in remote areas.

DESIGN

Randomized clinical trial with two intervention arms: 1) tobacco and physical activity; 2) medication adherence and a heart-healthy AN diet.

PARTICIPANTS

Participants are N = 300 AN men and women current smokers with high blood pressure or high cholesterol.

INTERVENTIONS

All participants receive motivational, stage-tailored, telemedicine-delivered counseling sessions at baseline and 3, 6, and 12 months follow-up; an individualized behavior change plan that is updated at each contact; and a behavior change manual. In Group 1, the focus is on tobacco and physical activity; a pedometer is provided and nicotine replacement therapy is offered. In Group 2, the focus is on medication adherence for treating hypertension and/or hypercholesterolemia; a medication bag and traditional food guide are provided.

MEASUREMENTS

With assessments at baseline, 3, 6, 12, and 18 months, the primary outcome is smoking status, assessed as 7-day point prevalence abstinence, biochemically verified with urine anabasine. Secondary outcomes include physical activity, blood pressure and cholesterol, medication compliance, diet, multiple risk behavior change indices, and cost-effectiveness.

COMMENTS

The current study has the potential to identify novel, feasible, acceptable, and efficacious interventions for treating the co-occurrence of CVD risk factors in AN people. Findings may inform personalized treatment and the development of effective and cost-effective intervention strategies for use in remote indigenous communities more broadly. Clinical Trial Registration # NCT02137902.

Address: Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, USA. Electronic address: [email protected].; Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, USA.; Alaska Native Tribal Health Consortium, Cardiology Department, Anchorage, AK, USA.; Veterans Affairs Health Economics Resource Center, USA.; Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, USA.; Departments of Medicine and Bioengineering & Therapeutic Sciences, Division of Clinical Pharmacology and Experimental Therapeutics, University of California, San Francisco, San Francisco, CA, USA.

DOI: 10.1016/j.cct.2018.06.003

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MeSH Terms: Adult, Alaska Natives, Behavior Control, Cardiovascular Agents, Cardiovascular Diseases, Distance Counseling, Exercise, Female, Humans, Male, Medication Adherence, Quality of Life, Risk Factors, Risk Reduction Behavior, Smoking Cessation, Telemedicine, Tobacco Use Disorder, Randomized Controlled Trials as Topic, Assessment of Medication Adherence