Trial Outcomes & Findings for mHealth Messaging to Motivate Quitline Use Quitting (NCT NCT03567993)

Last Updated: 2024-02-14

Results Overview

7 day point prevalence cessation per self-report with additional carbon monoxide monitor verification for those who report cessation.

Recruitment status

COMPLETED

Study phase

Target enrollment

750 participants

Primary outcome timeframe

At 6 months post-randomization

Results posted on

2024-02-14

Participant Flow

Recruitment occurred over a 22-month period, from November 23, 2018, through October 7, 2020.

During monthly recruitment events, study staff screened interested individuals for eligibility, consented, and enrolled eligible individuals in the study. Enrolled participants completed a baseline survey before randomization. No participants were excluded between enrollment and assignment to study arms.

Participant milestones

Participant milestones
Measure	Comparison The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. Comparison: Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention.	Intervention The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user. Intervention: Participants randomized to the intervention arm will receive: 1. Motivational Messages 2. Abstinence and Motivation to Use Services Assessments 3. Encouragement to access the Quitline 4. Encouragement to use Nicotine Replacement Therapy (NRT) 5. Provision of NRT, if requested Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT.
Overall Study STARTED	378	372
Overall Study COMPLETED	372	369
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Comparison The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. Comparison: Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention.	Intervention The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user. Intervention: Participants randomized to the intervention arm will receive: 1. Motivational Messages 2. Abstinence and Motivation to Use Services Assessments 3. Encouragement to access the Quitline 4. Encouragement to use Nicotine Replacement Therapy (NRT) 5. Provision of NRT, if requested Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT.
Overall Study Lost to Follow-up	4	2
Overall Study Death	1	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

mHealth Messaging to Motivate Quitline Use Quitting

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: At 6 months post-randomization

Population: The number of participants analyzed did not differ from the number of participants assigned to the arm or comparison group.

7 day point prevalence cessation per self-report with additional carbon monoxide monitor verification for those who report cessation.

Outcome measures

Outcome measures
Measure	Comparison n=372 Participants The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. Comparison: Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention.	Intervention n=369 Participants The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user. Intervention: Participants randomized to the intervention arm will receive: 1. Motivational Messages 2. Abstinence and Motivation to Use Services Assessments 3. Encouragement to access the Quitline 4. Encouragement to use Nicotine Replacement Therapy (NRT) 5. Provision of NRT, if requested Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT.
Participant Tobacco Cessation Rate (Quit Rate) at 6 Months	.50 proportion of participants	.52 proportion of participants

SECONDARY outcome

Timeframe: From randomization to 6 months post-randomization

Population: The number of participants analyzed did not differ from the number of participants assigned to the arm or comparison group.

Study team will administer the Self Efficacy Questionnaire (SEQ-12), an 12-item questionnaire to measure self-reported confidence of current and former smokers in their ability to abstain from smoking in high-risk situations (e.g., when facing internal stimuli (e.g., feeling depressed) and external stimuli (e.g., being with smokers)). The SEQ-12 consists of 12 items; each item is rated on a 5-point Likert scale (1=not at all sure, 2=not very sure, 3=more or less sure, 4=fairly sure, and 5=absolutely sure). SEQ-12 scores range from 12 to 60, with higher scores indicating greater self-efficacy. Individual items are summed to compute the total score. The outcome will measure the change in SEQ-12 scores from baseline to 6 months post-randomization.

Outcome measures

Outcome measures
Measure	Comparison n=372 Participants The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. Comparison: Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention.	Intervention n=369 Participants The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user. Intervention: Participants randomized to the intervention arm will receive: 1. Motivational Messages 2. Abstinence and Motivation to Use Services Assessments 3. Encouragement to access the Quitline 4. Encouragement to use Nicotine Replacement Therapy (NRT) 5. Provision of NRT, if requested Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT.
Change in Self-efficacy Scores Using the Self Efficacy Questionnaire (SEQ-12)	43 SEQ-12 scores Standard Deviation 10.2	43 SEQ-12 scores Standard Deviation 10.6

Adverse Events

Comparison

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Comparison n=378 participants at risk The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. Comparison: Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention.	Intervention n=372 participants at risk The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user. Intervention: Participants randomized to the intervention arm will receive: 1. Motivational Messages 2. Abstinence and Motivation to Use Services Assessments 3. Encouragement to access the Quitline 4. Encouragement to use Nicotine Replacement Therapy (NRT) 5. Provision of NRT, if requested Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT.
Respiratory, thoracic and mediastinal disorders Death	0.26% 1/378 • Number of events 1 • Adverse event data were collected through study completion, an average of 6 months. The study used the clinicaltrials.gov definition of adverse events and serious adverse events.	0.00% 0/372 • Adverse event data were collected through study completion, an average of 6 months. The study used the clinicaltrials.gov definition of adverse events and serious adverse events.
Cardiac disorders Death	0.00% 0/378 • Adverse event data were collected through study completion, an average of 6 months. The study used the clinicaltrials.gov definition of adverse events and serious adverse events.	0.27% 1/372 • Number of events 1 • Adverse event data were collected through study completion, an average of 6 months. The study used the clinicaltrials.gov definition of adverse events and serious adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rajani Sadasivam

UMass Chan Medical School

Phone: 508-456-8923

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Comparison n=377 Participants The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. Comparison: Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention.	Intervention n=372 Participants The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user. Intervention: Participants randomized to the intervention arm will receive: 1. Motivational Messages 2. Abstinence and Motivation to Use Services Assessments 3. Encouragement to access the Quitline 4. Encouragement to use Nicotine Replacement Therapy (NRT) 5. Provision of NRT, if requested Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT.	Total n=749 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	364 Participants n=5 Participants	364 Participants n=7 Participants	728 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous	42.7 years STANDARD_DEVIATION 12.6 • n=5 Participants	42.7 years STANDARD_DEVIATION 12.5 • n=7 Participants	42.7 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	377 Participants n=5 Participants	372 Participants n=7 Participants	749 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	377 Participants n=5 Participants	372 Participants n=7 Participants	749 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	377 Participants n=5 Participants	372 Participants n=7 Participants	749 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Vietnam	377 participants n=5 Participants	372 participants n=7 Participants	749 participants n=5 Participants
Baseline Smoking Self-Efficacy (SEQ-12) Questionnaire	33 Scores on a Scale STANDARD_DEVIATION 9.9 • n=5 Participants	32 Scores on a Scale STANDARD_DEVIATION 9.9 • n=7 Participants	32.8 Scores on a Scale STANDARD_DEVIATION 9.9 • n=5 Participants