mHealth Messaging to Motivate Quitline Use Quitting

Tobacco Use Cessation Clinical Trial

— M2Q2  

Official title:

mHealth Messaging to Motivate Quitline Use and Quitting (M2Q2): RCT in Rural Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567993
• Other study ID #: H00012953
• Secondary ID: R01TW010647
• Status: Completed
• Phase: N/A
• Start date: November 23, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2024
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The mHealth Messaging to Motivate Quitline Use and Quitting, or "M2Q2" study, is a collaborative research project for a mobile health intervention designed to motivate smoking cessation and encourage access to counseling. The study is for men and women smokers in Vietnam's Red River Delta region who are 18 years of age or older.

The primary hypothesis is that smokers in the M2Q2 intervention will have higher rates of smoking cessation, compared with the comparison group.

Description:

The specific aims of the M2Q2 study are:

Aim 1: In collaboration with the Institute of Population, Health, and Development (PHAD) in Vietnam, adapt a current, effective messaging system to Vietnam. The messaging system will:

1. Motivate smokers to quit smoking, using tailored messages adapted to be culturally relevant.

2. Encourage smokers to accept counseling services from the Quitline, and take advantage of nicotine replacement therapy (NRT) that will be provided by the Quitline to those willing to quit.

Aim 2: To engage with the Quitline, providing additional training in tobacco cessation counseling for those ready to quit, and motivational interventions for those not yet ready to quit.

Aim 3: To evaluate the impact of the messaging system on: access to the Quitline, use of nicotine replacement therapy, increase in self-efficacy, and six-month biochemically verified smoking cessation.

The study will be conducted in the Red River Delta Region, an agriculturally rich and densely populated area in northern Vietnam. Four communes (Viet Hung, Binh Minh, Tan Viet and Bach Sam) located in four different districts in the Hung Yen province will be included in the M2Q2 study, based on their general representativeness to the rural northern Vietnamese population and because the investigators have developed infrastructure to support technology-assisted behavioral interventions through community health centers (CHCs) in these communes. Each of the selected communes satisfy the following criteria: (1) have a community health center with a medical doctor; (2) are not currently participating in other studies for smoking cessation; and (3) have a minimum geographic separation of 12 kilometers (7 miles) from all other study communes to minimize possible contamination.

Recruitment and retention of study participants will be conducted by both CHC staff and community health workers. The investigators will recruit men and women, and plan for recruiting 15% women. The investigators will plan to recruit smokers regardless of their readiness to quit. Participants will not be compensated, other than being provided a cellphone if they currently do not own one.

The duration of an individual subject's participation in the study is 6 months (baseline survey, texting system, quitline data, and the 6-month follow-up survey). The duration anticipated to enroll all study subjects is 2 years, 2 months. The estimated date for the investigators to complete this study with primary analyses is the middle of year 5.

The main dependent variable is patient tobacco cessation rate (quit rate) at six months. The investigators will biochemically verify smoking status at baseline and at six months. The secondary outcome measure is self-efficacy. The investigators will administer an 12-item questionnaire (SEQ-12) to measure self-efficacy at baseline and at six months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: March 31, 2023
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18 years of age.

2. Resident of a selected commune.

3. Be a current smoker.

4. Be able to receive texts and read text (literate).

5. Not be cognitively impaired (as assessed by study staff).

6. Not have helped develop messages used in the intervention.

7. Not be a family member of another participant in the study.

Exclusion Criteria:

1. <18 years of age.

2. Cognitively impaired (as assessed by study staff).

3. Pregnant.

4. Prisoner.

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• 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
Participants randomized to the intervention arm will receive: Motivational Messages Abstinence and Motivation to Use Services Assessments Encouragement to access the Quitline Encouragement to use Nicotine Replacement Therapy (NRT) 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.

Locations

Country	Name	City	State
Vietnam	Institute of Population, Health, and Development (PHAD)	Hanoi

Sponsors (4)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Fogarty International Center of the National Institute of Health, Institute of Population, Health and Development, Vietnam, National Institutes of Health (NIH)

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Tobacco Cessation Rate (Quit Rate) at 6 Months	7 day point prevalence cessation per self-report with additional carbon monoxide monitor verification for those who report cessation.	At 6 months post-randomization
Secondary	Change in Self-efficacy Scores Using the Self Efficacy Questionnaire (SEQ-12)	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.	From randomization to 6 months post-randomization