Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110595729653 Date of Approval: 06/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Spirometry as a motivator for cessation among patients attending the smoking cessation clinic of Monastir –Tunisia
Official scientific title Spirometry as a motivator for cessation among patients attending the smoking cessation clinic
Brief summary describing the background and objectives of the trial During the past two decades, tobacco control efforts have been proven to be successful, global tobacco use prevalence has fallen . As a consequence, a clear decrease of its harmful effects such as lung cancer has been noted, particularly in developed countries. Nevertheless, tobacco use remains a major public health problem especially in developing countries and emerging economies. Health structures countermeasure-procedures prove to be unsatisfying. Therefore, many innovative strategies have been designed and put into test to enhance patient motivation toward tobacco cessation. Motivation is where the biggest challenge of smoking cessation prevails, therefore medical institutions and teams are constantly developing tools to enhance patient motivation toward cessation mainly through a presentation of the adverse effects of smoking versus the benefits if quitting and assistance during the quitting procedure. Many tools can be involved in this approach: motivational advice and interviewing, family assisted approaches, complimentary screening, and the development of mobile applications. Lung health monitoring is an objective way to explicitly show smoking adverse effect on health status. By emphasizing measurable effects of tobacco on lungs we may turning patient attention to the importance of quitting and enhance his motivation toward cessation. In fact, many interventions have been adopted to tackle this highly challenging issue, among them was pulmonary function test (PFT) or spirometry including lung age determination and communication, yet recent reviews have shown significantly controversial results [6] [7]. This study aimed to assess the effectiveness of announcing spirometry results and lung age on smoking cessation among patients attending the smoking cessation clinic (SCC) of Monastir.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2017
Actual trial start date
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 456
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Spirometry one year follow up Participants assigned to the intervention group received standardized information about their spirometry during a dedicated cession lasting approximately 30 minutes, where a spirometry was performed, a brief summary of its results and their interpretation and functional implications was given. The participant was also be informed about the “lung age” compared to the chronological age. 220
Control Group usual care one year follow up A control arm receiving standard program of smoking cessation and intervention arm receiving a spirometry and lung age announcement along with usual care. 236 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants were cigarettes smokers Aged more tha 18 years old Selected among patients who attended the SCC, from June 2017 to February 2020 Accepted to take part in the survey Patients who were not eligible for performing spirometry test in the intervention group. Patients with missing or incorrect contact information Patients who were unreachable after more than 3 call attempts in different occasions Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/06/2016 comitee of ethics and reseach
Ethics Committee Address
Street address City Postal code Country
University Hospital Farhat Hached , Street Ibn El Jazzar Sousse 4000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome smoking cessation at one year of follow up
Secondary Outcome smoking cessation status at 6 months of follow up 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Smoking cessation center in the university hospital of Monastir Street Avicenne Monastir 5000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hospital Fattouma Bourguiba of Monastir Street 1er juin 1995 monastir 5000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asma Belguith Sriha belguit_asma@yahoo.fr +21097238022 Street avicenne
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia Head of department Hospita Fattouma Bourguiba of Monastir
Role Name Email Phone Street address
Scientific Enquiries Manel Ben Fredj manel-ben-fredj@hotmail.fr +21652720545 Street avicenne
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia Assistant Professor
Role Name Email Phone Street address
Public Enquiries Behaeddine Garrach behaeddingarrach@gmail.com +21654313495 Street avicenne
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia Specialist in Family medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data collected during trial (text, tables) Statistical Analysis Plan immediatetly following publication and ending 36 months following article publiction anyone who wishes access to the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 06/09/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 06/09/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information