Feasibility of providing support to stop the use of smokeless tobacco through dentists in Pakistan
| ISRCTN | ISRCTN18072109 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18072109 |
| Secondary identifying numbers | AC21068 |
- Submission date
- 30/10/2021
- Registration date
- 13/01/2022
- Last edited
- 16/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Tobacco use is the single most preventable cause of premature death and disability. The use of smokeless tobacco (ST) alone accounts for 9% of all deaths attributable to tobacco use. The use of ST in Pakistan has deep-rooted cultural and traditional ties. ‘Pan’-largely considered as an occasional delicacy -is often a part of the festive celebrations and is consumed by young and old, women and men, alike. Whereas, ‘naswar’-the most popular ST product in Pakistan- packed in transparent polyethylene bags without any health warning- is sold to minors openly across Khyber Pakhtunkhwa (KPK), Pakistan.
While many tobacco users wish to quit, majority fail to do so. Dependence on tobacco makes it challenging to quit and support for cessation is often minimal in most countries. Behavioural support for tobacco cessation is a cost effective intervention which typically involves offering advice to quit tobacco use, providing information on how to quit, or a combination of both. Research suggests that behavioural support for tobacco cessation offered by healthcare workers (HCWs)-whether it is in the form of brief advice to stop tobacco use or more intensive behavioural support to quit-is effective in helping users quit. Dentists have a role to play in identifying any changes in the oral cavity caused by the use of smokeless tobacco. Dentists can play a very important role in helping their patients quit the use of tobacco. While dentists help their patients quit the use of ST in some countries, it is not known how this will work for Pakistan. This study aims to find out how feasible it is for dentists to help their patients quit the use of ST by offering a behavior support intervention during their routine clinical practice.
Who can participate?
Dental patients, aged 18 years and above, who use smokeless tobacco and are visiting the two study sites for a periodontal or prosthodontics treatment.
What does the study involve?
This study is looking at dental patients who use smokeless tobacco (ST). The main purpose of the study is to see how feasible it is to provide quit support to smokeless tobacco users via dentists in Pakistan.
The study will involve three steps. In the first step interviews will be conducted with dental patients and dentists to get their views about the intervention (behavior support to quit tobacco). In light of the findings of these interviews changes will be made to the intervention so that it is suitable to be delivered to dental patients by dentists during routine clinical practice. In Step 2 of this study, the intervention will be delivered via dentists to dental patients who use smokeless tobacco. Participants will be randomly allocated to one of the two groups. The first group will receive the intervention from their dentist. This intervention will involve face to face counselling delivered in three visits. The 2nd group will receive self-help material to quit ST use. All participants will receive the dental treatment for which they are visiting the hospital. All participants will be followed up telepathically at 3 and 6 months to assess quit rates and ST use. Quit rates at 6 months will be validated by cotinine testing of saliva samples at 6 months.
Finally interviews will be conducted with some of the trial participants and dentists who delivered the intervention to explore their opinions, views and experiences about the trial and intervention.
What are the possible benefits and risks of participating?
Participants will benefit from the quit support offered to them whether it is face to face counselling or from the self-help material. This will hopefully help reduce ST use which will prove beneficial for general and oral health. There are no known risks involved with participating.
Where is the study from?
University of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
October 2020 to October 2022
Who is funding the study?
Khyber Medical University (Pakistan)
Who is the main contact?
Dr. Shaista Rasool, s.rasool-3@sms.ed.ac.uk
Contact information
Scientific
House 156
street 5 sector k 1 phase 3
Hayatabad
Peshawar
25000
Pakistan
| Phone | +92 3329144869 |
|---|---|
| s.rasool-3@sms.ed.ac.uk |
Public
House 156
street 5 sector k 1 phase 3
Hayatabad
Peshawar
25000
Pakistan
| Phone | +92 3329144869 |
|---|---|
| s.rasool-3@sms.ed.ac.uk |
Study information
| Study design | Multi-center randomized controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet. |
| Scientific title | Behavior change intervention for smokeless tobacco (ST) cessation delivered through dentists within a dental setting: a pilot feasibility study |
| Study objectives | The aim of this study is to assess the feasibility and acceptability of delivering a behavioral support intervention for smokeless tobacco cessation via dentists within the existing dental settings in Pakistan. |
| Ethics approval(s) | Approved 06/09/2021, Edinburgh Medical School Research Ethics Committee (EMREC, Queen’s Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh, EH16 4TJ, UK; no telephone number provided; emrec@ed.ac.uk), ref: 21-EMREC-024 |
| Health condition(s) or problem(s) studied | Smokeless tobacco cessation in dental patients |
| Intervention | Step 1: BISCA- (Behavioral support Intervention for Smokeless Tobacco Cessation in South Asians) is a behavioral support intervention for smokeless tobacco(ST) cessation. This study aims to deliver BISCA via dentist during routine clinical practice in a pilot, randomized controlled trial. Before the trial, interviews will be undertaken with dental patients who are ST users and dentists working at the study sites. The purpose of this qualitative work is to adapt BISCA to meet the needs and cultural context of dental patients in Khyber Pakhtunkhwa, Pakistan, to identify the issues influencing dentist’s behavior of offering quit support to their patients and to inform the trial design. Step 2: Pilot Randomized controlled trial. Following assessment of eligibility, completion of informed consent, and collection of baseline data, the participants (dental patients) will be randomized to one of two groups. Participants will be randomly assigned to the control or intervention arm in a 1:1 allocation ratio according to the randomization schedule generated by STATA using permuted blocks of random sizes. The randomization code will be contained in a sealed opaque envelope, each bearing on the outside the name of the study site and a unique number for each participant. Control group: Participants will receive self-help quit material from their dentist. Intervention group: Participants in the intervention group will receive the behavioral support intervention for smokeless tobacco cessation. This will be delivered by their dentist in three sessions. For all participants, follow up will involve routine dental treatment delivered over several appointments as deemed appropriate by the dentist treating the participant. Additionally all participants will be followed up at 3 and 6 months telepathically to ascertain ST use/quit status. Step 3: A sample of the participants will be asked to attend 1 additional visit for qualitative interviews about their experiences in the study. Additionally the dentists involved in delivering the intervention will also be interviewed to share their opinion about the intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Eligibility rate: will be assessed from the screening record at the end of recruitment. 2. Patients willingness to participate in the trial: Will be assessed from the screening record at the end of the trial. 3. Dentists’ willingness to participate in the trial: Will be measured by counting the number of dentists consenting to participate versus the number of eligible dentists working in the selected wards at the study sites. 4. Recruitment rate: Will measured by counting the number of participants who have consented to participate in the study out of the total eligible participants. 5. Retention rate: Will be measured by counting the number of participants who remained in the study at end of 6 month follow up after the trial. 6. Randomized group contamination rates (i.e. the extent of cross-over between the two arms of the trial) will be established by audio recording the sessions delivered by the dentists (both of the arms) 7. Self-reported ST use (Use of ST and frequency of ST use per day), will be assessed for all patients. 8. Tobacco dependence scores( mean +/- SD) will be estimated using Fagerström test for nicotine dependence for smokeless tobacco(FTND-ST)& Oklahoma Scale for Smokeless Tobacco Dependence (OSSTD) 9. Participants adherence to the intervention will be measured by estimating the completion rates of the self-help calendars. 10. Fidelity to the intervention: Will be assessed by audio recording of the sessions. Fidelity index for the intervention already exists which consists of 29-items. Of these 22 items (representing the intervention components) are included in the ‘adherence index’ whereas seven items (assessing the competence with which the intervention is delivered)- are included in the ‘quality index’. 11. Self-reported quit rates will be measured at 3 and 6 month telephonic follow up after the trial. 12. Biochemical verification of quit rates will be done at 6 months following trial completion. 13. Acceptability of the dentists and issues with delivering the intervention will be assessed through qualitative interviews after trial completion. 14. Acceptability and experiences of the dental patients regarding the intervention and trial will be assessed through qualitative interviews. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 13/10/2020 |
| Completion date | 01/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Aged 18 years and above. 2. Regular smokeless tobacco users (regular use = at least once in 7 days for 6 months or more). 3. Those residing in the catchment area of the study sites. 4. Willingness to visit the study site multiple times. 5. Willing and able to provide written informed consent. |
| Key exclusion criteria | 1. Currently accessing cessation support. 2. Less than 18 years old. 3. Those residing out of the catchment area of the study sites. 4. Unwilling or unable to provide written informed consent. |
| Date of first enrolment | 25/01/2022 |
| Date of final enrolment | 02/03/2022 |
Locations
Countries of recruitment
- Pakistan
Study participating centres
University of Peshawar
University Rd
Peshawar
25000
Pakistan
Academy Town
University Town
Peshawar
25000
Pakistan
Sponsor information
University/education
Old Town
Edinburgh
EH8 9YL
Scotland
United Kingdom
| Phone | +44 (0)131 650 2230 |
|---|---|
| ellie.mcmaster@ed.ac.uk | |
| Website | http://www.ed.ac.uk/home |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 02/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The findings of this research will be disseminated both locally (meetings with the research board of the study sites and departmental meetings at Khyber Medical University), and nationally and internationally via presentations at research conferences. The results of the research will be written up for submission for publication in peer reviewed national and international journals. A summary of the findings will also be shared with the participants via email or post (upon request). Furthermore, it is likely that the findings of this research will be of interest to the general public, and Khyber Medical University and University of Edinburgh have established press offices for communicating findings of research to the press in an appropriate format. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/12/2023 | 16/02/2024 | Yes | No |
Editorial Notes
16/02/2024: Publication reference added.
02/11/2023: The intention to publish date was changed from 01/10/2023 to 02/02/2024.
10/03/2022: The recruitment end date has been changed from 15/03/2022 to 02/03/2022.
02/02/2022: The recruitment start date has been changed from 01/02/2022 to 25/01/2022.
02/11/2021: Trial's existence confirmed by University of Edinburgh.
