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临床试验/NCT03645941
NCT03645941已完成不适用

Social Media Intervention to Promote Smoking Treatment Utilization and Cessation Among Alaska Native Smokers

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年12月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
61
试验地点
1
主要终点
Smoking Cessation Program Completion

研究概览

简要总结

The prevalence of smoking among US adults is highest among American Indians and Alaska Native (AI/AN) persons; however, there are a lack of tobacco cessation interventions developed specific to this disparity group. Social media holds promise as a scalable intervention strategy to promote engagement in treatment and cessation outcomes for Alaska Native (AN) people.

Researchers plan to develop and pilot test a culturally relevant, Facebook delivered intervention to promote smoking treatment uptake and cessation among AN smokers. The Facebook content will include a digital storytelling approach adapted from the effective Centers for Disease Control (CDC) Tips from Former Smokers educational mass media campaign. The project builds on the researcher team's longstanding tobacco control research partnership with the AN community and was informed by their understanding of cultural factors that can both impede and encourage cessation in this population. If the pilot intervention is successful, researchers will have a blueprint to conduct a large randomized controlled trial. The researchers long-term objective is to develop interventions for AN tobacco users that will ultimately reduce their risk of tobacco-caused disease and mortality.

详细描述

The Behavioral Health Research Program at Mayo Clinic will be coordinating the study (recruit, train, oversee, etc.), but the project will take place in Alaska. The study will be conducted at the Alaska Native Tribal Health Consortium (ANTHC) in Anchorage. All data collection and the intervention will be conducted by study staff at ANTHC and Mayo Clinic. For qualitative data collection, a semi-structured interviewer guide will be developed and the project coordinator in Alaska will conduct the interviews. Researchers will provide training for the project coordinator on-site in Anchorage including 4 hours of didactic instruction followed by 4 practice hours of mock interviews and a certified completion interview. All sessions will be audiotaped. These transcripts will be coded by the researchers to assess counselor adherence to the proscribed intervention, and feedback will be provided during weekly research team teleconferences.

Mayo Clinic social media department will create the Facebook group page, develop the content library of moderator postings, and set up the software to capture participant use data. A random sample of 20% of moderator postings and responses to participant inquiries and discussions will be selected every week for the first four weeks and monthly thereafter. These transcripts will be coded by the researchers to assess moderator adherence to the proscribed intervention, and feedback will be provided during weekly research team teleconferences.

A manual of study procedures will be developed for the project coordinator in Alaska (AK). A Mayo Clinic program coordinator and clinical trials coordinator, will travel with a Mayo Clinic Co-Investigator to Anchorage, AK, to train the project coordinator on the data collection and other study procedures. The same coordination, communication, and quality control procedures will be used that have been successfully utilized in previous work. For ongoing trials in Alaska, weekly conference calls are scheduled with study staff in AK and at Mayo Clinic to discuss progress and problem solve issues related to recruitment and data collection. Quality control of the data is also monitored on site through review of participant forms and procedures every 3 months. The biostatistician on this protocol will oversee the transfer of data forms, electronic data, and data storage. The Mayo Survey Research Center will electronically transfer all data to the biostatistician. The quality of the data (data checks) including missing data and presence and frequency of outliers will be monitored once per month by the biostatistician. For study recruitment, the project coordinator will track posting of ads through Facebook (FB) and in Alaska local newsletters and websites.

All measures will be administered online using Qualtrics software, a data security service. An email link will be sent automatically by the Mayo Clinic Survey Research Center to complete the assessment. If a participant does not complete online assessments, the participant will be contacted through email or by phone by the project coordinator and prompted to complete the assessment. Data collected from survey responses will be handled and maintained by the Mayo Clinic Survey Research Center and a de-identified database of responses will be provided to the investigators. Interview forms and audio tapes will be labeled with subject ID numbers only; all personal identifiers will be removed before the data are sent to Mayo Clinic for analysis. At Mayo Clinic the audio tapes will be stored in a locked file drawer accessible only to the PI, Co-Investigator, and the project coordinator. These will be destroyed once the interviews are fully transcribed.

A trained research assistant at Mayo Clinic will mail the saliva sample kit to the participant; and the saliva samples, labeled with a subject identifier (ID) number only, will be shipped directly back to Mayo Clinic for analysis of cotinine. Once the specimen sample is processed and results posted, the sample will be destroyed immediately.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Inclusion and

排除标准

  • •Participants must be:
  • •>19 years of age (legal smoking age),
  • •Alaska Native race/ethnicity,
  • •smoke at least 1 cigarette per day over the past 7 day period,
  • •if other tobacco use, cigarettes are the main tobacco product used,
  • •considering or willing to make a quit attempt,
  • •access to internet,
  • •have an existing Facebook account or willing to set up an account, and
  • •is not using pharmacotherapy or has not enrolled in a program to stop smoking for past 3 months.
  • •Each person is only eligible to participate in one part of the study.

研究组 & 干预措施

Quitline/Treatment Referral

No Intervention

Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)

Facebook+Quitline/Treatment Referral

Experimental
  • Participants join a secret/private, culturally relevant Facebook group moderated by an AN tobacco research counselor for 3 months
  • Once daily moderator postings for 30 days, repeated each month for 3 months; plus 3-4 daily check-ins/postings to respond to participant generated content and encourage sharing of personal stories/experiences relevant to all stages of the quitting process and treatment engagement
  • Description of tobacco treatment services, phone numbers and web links sent via postal mail (printed materials) and email. Treatment options provide free, professional assistance based on U.S. clinical practice guidelines: (1)AK quitline, (2)regional tribal tobacco cessation programs, and (3)smokefree.gov resources (e.g., free texting program and smartphone application, quit guide)

干预措施: Facebook Group (Behavioral)

结局指标

主要结局

Smoking Cessation Program Completion

时间窗: 6 month follow-up assessment

The number of participants that completed the smoking cessation program and all activities per protocol

Biochemically Confirmed Abstinence From Smoking

时间窗: 6 months

Number of participants to have biochemically verified smoking abstinence by saliva specimen with cotinine level \<15ng/ml

次要结局

  • Self-reported 7-day Point Prevalence Smoking Abstinence(6 months)
  • Self-reported Use of Evidence-based Cessation Treatments(6 months)
  • Quit Attempts(6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christi Patten

Principal Investigator

Mayo Clinic

研究点 (1)

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