Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, USA.
Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, USA.
Contemp Clin Trials. 2018 Aug;71:40-46. doi: 10.1016/j.cct.2018.06.003. Epub 2018 Jun 2.
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.
Randomized clinical trial with two intervention arms: 1) tobacco and physical activity; 2) medication adherence and a heart-healthy AN diet.
Participants are N = 300 AN men and women current smokers with high blood pressure or high cholesterol.
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.
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.
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.
烟草使用和与烟草相关的疾病不成比例地影响到阿拉斯加原住民（AN）人群。本研究通过远程医疗，旨在为偏远地区的 AN 人群识别出针对烟草使用和其他心血管疾病（CVD）风险行为的文化定制、理论驱动、有效的干预措施。
有两个干预组的随机临床试验：1）烟草和体力活动；2）药物依从性和健康的 AN 饮食。
参与者为 300 名 AN 男性和女性当前吸烟者，他们患有高血压或高胆固醇。
所有参与者在基线和 3、6 和 12 个月随访时接受动机性、阶段定制、远程医疗提供的咨询；在每次接触时都会更新个性化的行为改变计划；并提供行为改变手册。在第 1 组中，重点是烟草和体力活动；提供计步器和尼古丁替代疗法。在第 2 组中，重点是治疗高血压和/或高胆固醇的药物依从性；提供药物袋和传统食物指南。
在基线、3、6、12 和 18 个月进行评估，主要结果是吸烟状况，评估为 7 天点患病率戒烟，通过尿液阿纳巴辛进行生物化学验证。次要结果包括体力活动、血压和胆固醇、药物依从性、饮食、多种风险行为改变指数和成本效益。
本研究有可能为治疗 AN 人群中 CVD 风险因素的共同发生确定新颖、可行、可接受和有效的干预措施。研究结果可能为个性化治疗提供信息，并为更广泛地在偏远的土著社区中开发有效和具有成本效益的干预策略提供信息。临床试验注册号：NCT02137902。
