Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03645941 |
| Other study ID # |
17-009947 |
| Secondary ID |
R34DA046008 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2019 |
| Est. completion date |
March 26, 2021 |
Study information
| Verified date |
June 2022 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
The study staff in Anchorage and Rochester will monitor any reports or observations of
medical problems or severe depression or other psychiatric symptoms in participants. The
Principal Investigator (PI) and a Co-Investigator from Stanford University, licensed clinical
psychologists, will be consulted by telephone to consult with the study staff as needed.
