Clinical trial NCT03567993: mHealth Messaging to Motivate Quitline Use Quitting
Official title: mHealth Messaging to Motivate Quitline Use and Quitting (M2Q2): RCT in Rural Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: mhealth
Tobacco cessation
Vietnam
Smoking cessation
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Institute of Population, Health and Development, Vietnam
name: National Institutes of Health (NIH)
name: Fogarty International Center of the National Institute of Health
First posted: 2018-06-26
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participant Tobacco Cessation Rate (Quit Rate) at 6 Months
timeFrame: At 6 months post-randomization
Secondary outcomes:
measure: Change in Self-efficacy Scores Using the Self Efficacy Questionnaire (SEQ-12)
timeFrame: From randomization to 6 months post-randomization
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Institute of Population, Health, and Development (PHAD)
Study officials:
affiliation: University of Massachusetts, Worcester
name: Rajani S Sadasivam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larkin C, Wijesundara J, Nguyen HL, Ha DA, Vuong A, Nguyen CK, Amante D, Ngo CQ, Phan PT, Pham QTL, Nguyen BN, Nguyen ATP, Nguyen PTT, Person S, Allison JJ, Houston TK, Sadasivam R. mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam. JMIR Res Protoc. 2021 Oct 7;10(10):e30947. doi: 10.2196/30947.