Ignite Creation Date:
2024-05-06 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05222958
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-01-24
Brief Title:
Effectiveness of an App for Tobacco Cessation in Pregnant Women TOBBGEST
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official Title:
Effectiveness of an App for Tobacco Cessation in Pregnant Women
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOBBGEST
Brief Summary:
Background Tobacco use during pregnancy is one of the most modifiable causes of morbidity and mortality for both pregnant women and their fetus Despite the fact that smoking among pregnant has decreased in recent years smoking continues to be a major public health problem
Hypothesis Research question The use of new technologies such as applications apps for mobile devices designed with a gamification strategy understood as an incentive through play could help women to quit smoking during pregnancy and in the long term A structured App-based intervention using gamification adapted to pregnant women will decrease smoking prevalence in this population
Objectives To evaluate the effectiveness of an intervention against tobacco in pregnant women based on an app for tobacco abstinence Specific objectives 1 To determine the effectiveness of the intervention on smoking cessation during pregnancy 2 Determine the effectiveness of the intervention in in the long term and 3 To determine the impact of the intervention to reduce smoking in pregnant women who continue smoking
Design Randomized multicentre community intervention trial
Setting Sexual and Reproductive Health Care Services of the Camp de Tarragona and Central Catalonia Primary Care Centres
Intervention the participants will have the usual clinical practice intervention and the intervention group IG will also have access to an app based on gamification verified by coximetry during the follow-up and with a cotinine test at the end
Analysis of groups by intention to treat abstinence rates will be compared and the determining factors will be evaluated using multivariate statistics
Expected results smoking cessation in the IG will be 5 compared to normal practice
Applicability and Relevance It promotes activities aimed to reduce tobacco consumption in the general population and especially in women in order to decrease comorbidity associated with long-term smoking which will lead to a reduction in tobacco-related diseases in the whole population
Hypothesis Research question The use of new technologies such as applications apps for mobile devices designed with a gamification strategy understood as an incentive through play could help women to quit smoking during pregnancy and in the long term A structured App-based intervention using gamification adapted to pregnant women will decrease smoking prevalence in this population
Objectives To evaluate the effectiveness of an intervention against tobacco in pregnant women based on an app for tobacco abstinence Specific objectives 1 To determine the effectiveness of the intervention on smoking cessation during pregnancy 2 Determine the effectiveness of the intervention in in the long term and 3 To determine the impact of the intervention to reduce smoking in pregnant women who continue smoking
Design Randomized multicentre community intervention trial
Setting Sexual and Reproductive Health Care Services of the Camp de Tarragona and Central Catalonia Primary Care Centres
Intervention the participants will have the usual clinical practice intervention and the intervention group IG will also have access to an app based on gamification verified by coximetry during the follow-up and with a cotinine test at the end
Analysis of groups by intention to treat abstinence rates will be compared and the determining factors will be evaluated using multivariate statistics
Expected results smoking cessation in the IG will be 5 compared to normal practice
Applicability and Relevance It promotes activities aimed to reduce tobacco consumption in the general population and especially in women in order to decrease comorbidity associated with long-term smoking which will lead to a reduction in tobacco-related diseases in the whole population
Detailed Description:
Design community-based intervention trial with simple random assignment
Setting and study population the study population will be drawn from the usual consultations of 4 Sexual and Reproductive Health Care Centres ASSIR responsible for pregnancy monitoring in the community managed by the Catalan Health Institute ICS in Tarragona and Barcelona
Study subjects pregnant women over 18 years of age who attended the ASSIR services and consented to participate in the study and meet the inclusion criteria
Randomisation process of the intervention the participants included will be assigned to receive or not to receive the proposed intervention The allocation sequence will be carried out consecutively centralised from the Research Support Unit of the Jordi Gol Primary Care Research Institute in Tarragona following a simple numerical randomisation ratio No masking will be possible either for pregnant women or for ASSIR professionals the data will be masked for the research team carrying out the statistical analyses
Selection of the participating centres the pregnancy monitoring centres participating in the recruitment of the study will be four all of them from the ICS Three in the Tarragona region Tarragona Reus and Valls and a fourth in the Osona region of Barcelona Manresa
Intervention ASSIR centre will offer treatment following the standard practice protocols to all participants who want to quit smoking following standard practice protocols Additionally only participants assigned to the intervention group will have the access code to the Tobbstop App wwwtobbsotopcom and its use will be recommended The quality of the intervention will be assured by a three-level control system
1 Adaptation of the App The Tobbstop App has been successfully tested in the general population For the present study the contents will be updated and adapted to the study population pregnant women In that sense a qualitative study will be carried out with the aim of identifying the facilities and barriers that pregnant women face to stop smoking through individual interviews and focus groups
2 Technical training Training will be carried out in each of the centres participating in the pregnancy control follow-up visits The training will be performed by health professionals in order to understand the use of the App
3 Centralised monitoring Confirmatory tests will be referred to a single reference observer who will centralise quality control and interpret the results urinary cotinine
Follow-up no additional follow-up visits will be planned for the study In the scheduled pregnancy follow-up visits smoking habits will be assessed by a questionnaire and CO level quantification by coximetry At the end of the pregnancy check-ups follow-up will be carried out by telephone contact Women who quit smoking will be scheduled to visit their health centre 12 months after the intervention to find out about their relationship with smoking If they report abstinence a coximetry test will be performed and if it is less than 10 ppm urinary cotinine will be determined
The cut-off point is considered to be 10 ppm as lower values indicate non-smoking and higher values indicate smoking in the previous 12-24 hours
Data recording the information from the study will be recorded in a structured way by a data collection questionnaire and will be stored in an application accessible from the corporate Intranet of the Catalan Institute of Health Access to this website is restricted and will be controlled by a personal password for each researcher who will be responsible for entering the records of the participants recruited
Definition of the outcome variable prolonged abstinence from drug use will be considered as the main variable and punctual abstinence as a secondary variable both validated by biochemical confirmation 12 months after the intervention Urine cotinine values less than 100ngml will reflect an abstinence condition values between 100 and 500 ngml will be accepted as occasional smoker and values above 500ngml will be considered as smoker
The criteria for establishing abstinence according to the recommendations of the Society for Research on Nicotine and Tobacco
Continuous abstinence sustained abstinence from the time of intervention to a follow-up period
Prolonged abstinence sustained abstinence between an initial grace period and a follow-up period
Punctual abstinence abstinence during a window of time usually 7 days immediately preceding the time of follow-up
Grace period is the period immediately following the defined quit date or intervention date in which continued smoking is not counted as failure For most studies it is recommended to be no longer than 2-4 weeks
In general continuous abstinence is accepted as the gold standard However this measure is too stringent and prolonged abstinence is preferred as it includes the participants who achierve sustained abstinence after a transitional grace period which would otherwise be considered failures
Sample calculation accepting an alpha risk of 005 and a beta risk of less than 02 in a bilateral contrast it will be necessary to include 200 participants in each group in order to detect the difference between the two proportions statistically significant In the control group is expected to be 05 and in the intervention group 065 A loss-to-follow-up rate of 5 is estimated The ARCSINUS approximation GRANMO Sample Size Calculator v712 available at wwwimimes was used
Setting and study population the study population will be drawn from the usual consultations of 4 Sexual and Reproductive Health Care Centres ASSIR responsible for pregnancy monitoring in the community managed by the Catalan Health Institute ICS in Tarragona and Barcelona
Study subjects pregnant women over 18 years of age who attended the ASSIR services and consented to participate in the study and meet the inclusion criteria
Randomisation process of the intervention the participants included will be assigned to receive or not to receive the proposed intervention The allocation sequence will be carried out consecutively centralised from the Research Support Unit of the Jordi Gol Primary Care Research Institute in Tarragona following a simple numerical randomisation ratio No masking will be possible either for pregnant women or for ASSIR professionals the data will be masked for the research team carrying out the statistical analyses
Selection of the participating centres the pregnancy monitoring centres participating in the recruitment of the study will be four all of them from the ICS Three in the Tarragona region Tarragona Reus and Valls and a fourth in the Osona region of Barcelona Manresa
Intervention ASSIR centre will offer treatment following the standard practice protocols to all participants who want to quit smoking following standard practice protocols Additionally only participants assigned to the intervention group will have the access code to the Tobbstop App wwwtobbsotopcom and its use will be recommended The quality of the intervention will be assured by a three-level control system
1 Adaptation of the App The Tobbstop App has been successfully tested in the general population For the present study the contents will be updated and adapted to the study population pregnant women In that sense a qualitative study will be carried out with the aim of identifying the facilities and barriers that pregnant women face to stop smoking through individual interviews and focus groups
2 Technical training Training will be carried out in each of the centres participating in the pregnancy control follow-up visits The training will be performed by health professionals in order to understand the use of the App
3 Centralised monitoring Confirmatory tests will be referred to a single reference observer who will centralise quality control and interpret the results urinary cotinine
Follow-up no additional follow-up visits will be planned for the study In the scheduled pregnancy follow-up visits smoking habits will be assessed by a questionnaire and CO level quantification by coximetry At the end of the pregnancy check-ups follow-up will be carried out by telephone contact Women who quit smoking will be scheduled to visit their health centre 12 months after the intervention to find out about their relationship with smoking If they report abstinence a coximetry test will be performed and if it is less than 10 ppm urinary cotinine will be determined
The cut-off point is considered to be 10 ppm as lower values indicate non-smoking and higher values indicate smoking in the previous 12-24 hours
Data recording the information from the study will be recorded in a structured way by a data collection questionnaire and will be stored in an application accessible from the corporate Intranet of the Catalan Institute of Health Access to this website is restricted and will be controlled by a personal password for each researcher who will be responsible for entering the records of the participants recruited
Definition of the outcome variable prolonged abstinence from drug use will be considered as the main variable and punctual abstinence as a secondary variable both validated by biochemical confirmation 12 months after the intervention Urine cotinine values less than 100ngml will reflect an abstinence condition values between 100 and 500 ngml will be accepted as occasional smoker and values above 500ngml will be considered as smoker
The criteria for establishing abstinence according to the recommendations of the Society for Research on Nicotine and Tobacco
Continuous abstinence sustained abstinence from the time of intervention to a follow-up period
Prolonged abstinence sustained abstinence between an initial grace period and a follow-up period
Punctual abstinence abstinence during a window of time usually 7 days immediately preceding the time of follow-up
Grace period is the period immediately following the defined quit date or intervention date in which continued smoking is not counted as failure For most studies it is recommended to be no longer than 2-4 weeks
In general continuous abstinence is accepted as the gold standard However this measure is too stringent and prolonged abstinence is preferred as it includes the participants who achierve sustained abstinence after a transitional grace period which would otherwise be considered failures
Sample calculation accepting an alpha risk of 005 and a beta risk of less than 02 in a bilateral contrast it will be necessary to include 200 participants in each group in order to detect the difference between the two proportions statistically significant In the control group is expected to be 05 and in the intervention group 065 A loss-to-follow-up rate of 5 is estimated The ARCSINUS approximation GRANMO Sample Size Calculator v712 available at wwwimimes was used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None