Trial Outcomes & Findings for Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study (NCT NCT02302859)

Results Overview

Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

3 months

Results posted on

2020-01-27

Participant Flow

Recruitment Period Opened January 2015 and Closed March 2016. Recruitment was accomplished in clinic setting of a large comprehensive HIV-care center.

Participant milestones

Participant milestones
Measure	Standard Treatment (ST) Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.	Automated Treatment (AT) Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.
Overall Study STARTED	2	6
Overall Study COMPLETED	1	4
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Treatment (ST) Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.	Automated Treatment (AT) Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.
Overall Study Lost Phone	1	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Treatment (ST) n=2 Participants Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.	Automated Treatment (AT) n=6 Participants Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.	Total n=8 Participants Total of all reporting groups
Age, Continuous	46 years n=5 Participants	54 years n=7 Participants	51 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Data were not collected due to early termination of the protocol

Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.

Outcome measures

Outcome data not reported

Adverse Events

Standard Treatment (ST)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Automated Treatment (AT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lorna McNeill, MPH,PHD/ Chair, Health Disparities Research

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713- 563-1103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place