NCT03927976

Brief Summary

Assess the feasibility and acceptability of delivering an mHealth tobacco intervention among state quitline enrollees.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

April 23, 2019

Last Update Submit

March 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility as measured by interest in using Path2Quit video text program

    The program will be evaluated as feasible if 50% of those screened are eligible and interested in the video text program AND if 90% of those who are eligible and interested in the video text program will be able to engage in the program (some may need technical assistance).

    Through study completion, an average of 6-weeks.

Secondary Outcomes (1)

  • Acceptability of intervention in terms of its Satisfaction and perceived helpfulness: 6-Week Follow-Up Questionnaire

    6 weeks from end of intervention

Study Arms (1)

Path2Quit

EXPERIMENTAL

After assessment eligibility, given consent, information about text messaging will be collected and participants enrolled in the Path2Quit culturally specific text message program and feedback will be collected on their experience.

Behavioral: Path2Quit - culturally specific text message intervention

Interventions

SMS text delivers over 6 weeks with links to 20-120 second video clips from PTF. The message library contains 155 videos and assessment questions. First message is tailored to wake-up times, and the topic of the video (e.g., Never Quit Quitting) accompanies the text. Messages are pushed to participants 1-2 times/day, with 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP). Participants also receive inquiry texts, designed to push videos of interest/relevance to the individual. The cultural adaptations are infused throughout the video segments. Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.

Path2Quit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identify as African American
  • Enrolled in state quitlines within the past 3 months
  • Have access to SMS texting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 25, 2019

Study Start

April 10, 2019

Primary Completion

December 30, 2019

Study Completion

February 10, 2020

Last Updated

March 16, 2020

Record last verified: 2020-03

Locations