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| ID | Type | Description | Link |
|---|---|---|---|
| R01TW010647 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Institute of Population, Health and Development, Vietnam | OTHER |
| National Institutes of Health (NIH) | NIH |
| Fogarty International Center of the National Institute of Health | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison | Active Comparator | The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. |
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| Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajani S Sadasivam, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Population, Health, and Development (PHAD) | Hanoi | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34617915 | Derived | 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. |
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IPD will not be made available to other researchers.
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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.
Recruitment occurred over a 22-month period, from November 23, 2018, through October 7, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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:
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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One comparison participant did not complete the baseline survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants analyzed did not differ from the number of participants assigned to the arm or comparison group. | Posted | Number | proportion of participants | At 6 months post-randomization |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | The participant had an underlying disease (COPD) and died of acute bronchospasm on 10/15/2019. This event was unrelated to the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajani Sadasivam | UMass Chan Medical School | 508-456-8923 | rajani.sadasivam@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2021 | Jun 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Intervention | Behavioral | Participants randomized to the intervention arm will receive:
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. |
|
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| From randomization to 6 months post-randomization |
| Withdrawal by Subject |
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| BG001 | 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:
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Smoking Self-Efficacy (SEQ-12) Questionnaire | The Smoking Self-Efficacy Questionnaire (SEQ-12) measures the 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. Items are summed to compute total score. | Mean | Standard Deviation | Scores on a Scale |
|
| OG001 |
| 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:
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. |
|
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| 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. | The number of participants analyzed did not differ from the number of participants assigned to the arm or comparison group. | Posted | Mean | Standard Deviation | SEQ-12 scores | From randomization to 6 months post-randomization |
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|
|
| 1 |
| 378 |
| 1 |
| 378 |
| 0 |
| 378 |
| EG001 | 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:
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. | 1 | 372 | 1 | 372 | 0 | 372 |
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| Death | Cardiac disorders | Non-systematic Assessment | The participant died at home at 13:00 on 12/16/2019 due to a stroke. This event was unrelated to the study. |
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