mHealth Messaging to Motivate Quitline Use Quitting

NCT ID: NCT03567993

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-23
• Study Completion Date: 2023-03-31

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.

Conditions

Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Comparison

The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group.

Group Type: ACTIVE_COMPARATOR

Comparison

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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 Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

mHealth Intervention

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Population, Health and Development, Vietnam

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Rajani Sadasivam

Associate Professor, Population and Quantitative Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajani S Sadasivam, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

Institute of Population, Health, and Development (PHAD)

Hanoi, , Vietnam

Countries

Vietnam

References

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.

Reference Type: DERIVED

PMID: 34617915 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01TW010647

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H00012953

Identifier Type: -

Identifier Source: org_study_id