Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study

Tobacco Dependence Clinical Trial

— HEALTHH  

Official title:

Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137902
• Other study ID #: 29638
• Secondary ID: 1R01HL117736
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: March 2020

Study information

• Verified date: January 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Tobacco/Physical Activity Intervention
Telemedicine stage-tailored counseling intervention focused on increasing intrinsic motivation and 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.
• Diet plus BP/CHOL Intervention
Telemedicine stage-tailored counseling intervention focused on increasing intrinsic motivation, goal setting for managing HTN and HCL, and adherence with antihypertensives and statins with supportive dietary changes. Includes a native diet cookbook and medication bag.

Locations

Country	Name	City	State
United States	Norton Sound Health Corporation	Nome	Alaska
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (6)

Lead Sponsor	Collaborator
Stanford University	Alaska Native Tribal Health Consortium, National Heart, Lung, and Blood Institute (NHLBI), Norton Sound Health Corporation, University of Alaska Anchorage, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

Prochaska JJ, Benowitz NL. Smoking cessation and the cardiovascular patient. Curr Opin Cardiol. 2015 Sep;30(5):506-11. doi: 10.1097/HCO.0000000000000204. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Status: 7-day point prevalence abstinence	Change from baseline as no tobacco use, including a puff, in the past 7 days	Assessed at baseline, 3, 6, 12, and 18 months
Secondary	Minutes of moderate-to-vigorous physical activity in past 7 days	self-reported minutes of moderate-to-vigorous physical activity	Assessed at baseline, 3, 6, 12, and 18 months
Secondary	Blood pressure	Measured as systolic/diastolic in mmHg	Assessed at baseline, 3, 6, 12, and 18 months
Secondary	Total, LDL, and HDL cholesterol	measured in milligrams per deciliter of blood (mg/dL)	Assessed at baseline and 18 months
Secondary	Body Mass Index (BMI)	weight (in kilograms) over height squared (in centimeters)	Assessed at baseline, 3, 6, 12, and 18 months
Secondary	Framingham Risk Factor Score	gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual	Assessed at baseline and 18 months
Secondary	Medication Adherence	self-reported assessment of adherence to BP and CHOL meds	Assessed at baseline, 3, 6, 12 and 18 months
Secondary	Dietary Quality	culturally tailored FFQ assessing consumption of native and non-native foods	Assessed at baseline, 3, 6, 12 and 18 months
Secondary	Multiple Risk Behavior Change Impact Factor	intervention efficacy times participation summed over the multiple behavioral targets, I = ?# of behaviors(n) (En × Pn)	Assessed at baseline, 3, 6, 12 and 18 months
Secondary	Linear index of multiple behavior change	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)	Assessed at baseline, 3, 6, 12 and 18 months