Health Literacy and Smoking Cessation in Low-SES Diverse Smokers - Project HALT II
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy of Helping Adults with Health Literacy Trouble (HALT) versus Standard Treatment (ST) in Facilitating Abstinence from Smoking in Low Health Literacy (HL) Smokers
研究概览
简要总结
In-Depth Interviews:
The goal of this research study is to learn about ways to help people might have trouble understanding health information quit smoking.
Pilot Study:
The goal of this research study is to test 2 different approaches, Standard Treatment (ST) and Helping Adults with Health Literacy Trouble (HALT) tailored treatment, for helping smokers who might have trouble understanding health information with quitting smoking.
详细描述
In-Depth Interviews:
Study Visit:
If participant is eligible and agrees to take part, the following will occur at their visit:
Questionnaire:
Participant will complete a questionnaire on a computer that will include questions about their thoughts about smoking, their smoking history, their ability to understand health information, and basic questions about their age, education, and income. This may take up to 45 minutes to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(IN-DEPTH INTERVIEWS - INCLUSION CRITERIA; 2-6)
- •Age 25-65 years
- •Current smoker (>/= 5 cigarettes/day for the last year)
- •Limited or marginal HL (total score </=6 on the CHEW Questionnaire)
- •Have a home address where information can be mailed and a working telephone
- •English speaker
- •Currently attending Adult Basic Education (ABE) classes at Literacy Advance of Houston
- •(PILOT STUDY - INCLUSION CRITERIA; 8-13)
- •Age 25-65 years
- •Current smoker (>/= 5 cigarettes/day for the last year; biochemically verified with expired carbon monoxide (CO) reading of >/=8 parts per million [ppm])
- •Limited or marginal HL (total score </=6 on the CHEW Questionnaire)
- •Motivated to quit smoking within the next 30 days
- •Have a home address where information can be mailed and a working telephone
- •English speaker
- •Currently attending Adult Basic Education (ABE) classes at Literacy Advance of Houston
排除标准
- •(IN-DEPTH INTERVIEWS - EXCLUSION CRITERIA; 2-5)
- •Regular use of tobacco products other than cigarettes
- •Current use of tobacco cessation medications
- •Pregnancy or lactation
- •Enrolled in another smoking cessation study/program
- •(PILOT STUDY - EXCLUSION CRITERIA; 7-12)
- •Contraindication for nicotine patch
- •Regular use of tobacco products other than cigarettes
- •Current use of tobacco cessation medications
- •Pregnancy or lactation
- •A household member is enrolled in the study
- •Enrolled in another smoking cessation study/program
研究组 & 干预措施
Project HALT II: In-Depth Interviews
Participants complete a computerized questionnaire to assess demographics and smoking history.
Participants take part in individual in-depth interviews discussing smoking history, attempts to quit, and suggestions for smoking cessation program.
干预措施: Questionnaire (Behavioral)
Project HALT II: In-Depth Interviews
Participants complete a computerized questionnaire to assess demographics and smoking history.
Participants take part in individual in-depth interviews discussing smoking history, attempts to quit, and suggestions for smoking cessation program.
干预措施: In-Depth Interviews (Behavioral)
Project HALT II: Standard Treatment (ST)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Questionnaire (Behavioral)
Project HALT II: Standard Treatment (ST)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Breath Test (Other)
Project HALT II: Standard Treatment (ST)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Nicotine Patches (Drug)
Project HALT II: Standard Treatment (ST)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Advice plus Phone Counseling (Behavioral)
Project HALT II: Standard Treatment (ST)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants receive phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Self Assessment Questionnaires (Behavioral)
Project HALT II: Tailored Treatment (HALT)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants scheduled to attend 5 individual, in-person smoking cessation treatment counseling sessions.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Questionnaire (Behavioral)
Project HALT II: Tailored Treatment (HALT)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants scheduled to attend 5 individual, in-person smoking cessation treatment counseling sessions.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Breath Test (Other)
Project HALT II: Tailored Treatment (HALT)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants scheduled to attend 5 individual, in-person smoking cessation treatment counseling sessions.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Nicotine Patches (Drug)
Project HALT II: Tailored Treatment (HALT)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants scheduled to attend 5 individual, in-person smoking cessation treatment counseling sessions.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Advice plus Counseling Sessions (Behavioral)
Project HALT II: Tailored Treatment (HALT)
Participants complete a computerized questionnaire to assess demographics and smoking history at baseline.
Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Participants receive brief advice to quit smoking. Participants scheduled to attend 5 individual, in-person smoking cessation treatment counseling sessions.
Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
干预措施: Self Assessment Questionnaires (Behavioral)
结局指标
主要结局
Efficacy of Helping Adults with Health Literacy Trouble (HALT) versus Standard Treatment (ST) in Facilitating Abstinence from Smoking in Low Health Literacy (HL) Smokers
时间窗: 3 months
Efficacy defined as the proportion of participants who successfully quit smoking.
次要结局
未报告次要终点