Evaluation of the Effectiveness of 5A-5R Counselling Services for Tobacco Cessation

NCT06501209 | Enrolling By Invitation DMC

• 1 other identifier: IRB-2024-IS-16
• Study Type: interventional
• Target: 714
• Locations: 1 country
• Sites: 1

Brief Summary

Noncommunicable diseases (NCDs) are a major health burden in Bangladesh, following global trends. Tobacco use, both smoking and smokeless, is a key risk factor for noncommunicable diseases (NCDs) such as cardiovascular disease, chronic lung disease, and cancer, accounting for a considerable portion of the country's mortality rate. The government has taken several steps to address this issue, including increasing tobacco pricing and implementing smoke-free rules. Despite efforts to lower tobacco demand, meeting the desired reduction in consumption appears difficult. Counseling emerges as a popular technique of smoke cessation, with research demonstrating its effectiveness. The 5A-5R counseling technique is a brief intervention that is encouraged by the Directorate General of Health Services (DGHS) in Bangladesh. This study aims to evaluate the effectiveness of mobile phone-assisted culturally appropriate 5A-5R counselling services for tobacco cessation among adults in union-level primary health care settings in Bangladesh. The trial will involve a cluster randomized controlled design with three arms: an intervention arm receiving in-person counselling, an intervention arm receiving in-person and mobile phone-assisted counselling, and a control arm receiving usual care without structured counselling. The primary outcome measures include tobacco cessation rates and reduction in tobacco consumption. The study duration is 8 months, with a preparatory phase, intervention phase, follow-up phase, and data analysis phase.

Conditions

Tobacco Use Cessation

Keywords

Noncommunicable diseases; Tobacco Use; mHealth; 5A-5R counseling

Outcome Measures

Primary Outcomes (1)

• Tobacco Cessation

  The number of participants with a history of current tobacco use have quitted their tobacco intake in any form measured by descriptive statistics (n,%) using questionnaires.

  8 months

Secondary Outcomes (3)

• Smoking Tobacco Reduction

  8 months

• Smokeless Tobacco Reduction

  8 months

• Change in knowledge, attitude, and practice of tobacco use by using 5 point Likert Scale.

  8 months

Study Arms (3)

5A-5R-based counseling Only

EXPERIMENTAL

Participants will get 5A-5R-based counseling with BCC materials

Behavioral: 5A-5R-based counselling session

5A-5R-based counseling and Mobile based remote support

EXPERIMENTAL

Participants will get 5A-5R-based counseling with BCC materials and Mobile based remote support

Behavioral: 5A-5R-based counselling session; Behavioral: Counseling through mobile phone call and text message

Control with usual care

NO INTERVENTION

Participants will get usual care only

Interventions

5A-5R-based counselling session BEHAVIORAL

The 5As (Ask, Advise, Assess, Assist, Arrange) summarize all the activities that a healthcare provider can do to help a tobacco user (both smoking within 3-5 minutes in a primary care setting. This model can guide you through the right process to talk to respondents who are ready to quit tobacco use and deliver advice. The 5 R's - relevance, risks, rewards, roadblocks, and repetition - are the content areas that should be addressed in a motivational counseling intervention to help those who are not ready to quit.

5A-5R-based counseling Only; 5A-5R-based counseling and Mobile based remote support

Counseling through mobile phone call and text message BEHAVIORAL

Participants will get weekly a phone call and a text message

5A-5R-based counseling and Mobile based remote support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age 18 and above) having a history of current tobacco consumption/use (daily tobacco use during the last six months).
• Willing to participate.

You may not qualify if:

• temporary resident at the selected study site.
• having a terminal illness.
• mentally unstable.

Sponsors & Collaborators

• BRAC University: lead
• Bangladesh Center for Communication Programs: collaborator
• Non Communicable Disease Control Program, DGHS, Bangladesh: collaborator

Study Sites (1)

BRAC James P Grant School of Public Health

Dhaka, 1213, Bangladesh

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Noncommunicable Diseases; Tobacco Use

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted in three community clinics (CC) and their catchment communities in 3 Unions (Sator, Mohonpur and Sotogram) in Dinajpur, a border-based district in Bangladesh. This small-scale intervention study will be conducted among men and women aged 18 and above. We will purposefully select 3 unions of Birganj upazila from Dinajpur district; one union will be selected for providing conventional 5A-5R based counselling service according to the national protocol for prevention of diabetes and hypertension to quit tobacco among current tobacco users, one union will be selected for delivering mobile phone assisted enhanced 5A-5R Based counselling service and the other one union will be selected as control that will continue with usual care without introducing any structured 5A-5R based counselling service for tobacco cessation.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 15, 2024
• Study Start: May 10, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 30, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)