CTRI/2023/05/052863 [Registered on: 18/05/2023] Trial Registered Prospectively

Quit Smoking App Clinical Trial

Quit Smoking App Clinical TrialQuit Smoking App Clinical TrialQuit Smoking App Clinical Trial

Quit Smoking App Clinical Trial

Quit Smoking App Clinical TrialQuit Smoking App Clinical TrialQuit Smoking App Clinical Trial
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Key Features of the Trial

Scientific Title

Scientific Title

Scientific Title

Randomized Controlled Trial for Smartphone-based Smoking Cessation Program

Public Title

Scientific Title

Scientific Title

Smoking Cessation Mobile App Effectiveness Trial

CTRI Registration

CTRI Registration

CTRI Registration

TRI/2023/05/052863 [Registered on: 18/05/2023] Trial Registered Prospectively

quitsure on ctri website

Objectives

CTRI Registration

CTRI Registration

  • To assess the impact of the Quit Smoking program on short-term and long-term smoking cessation.
  • To determine the level of engagement with the Quit smoking smartphone app and
  • To assess the feasibility of the application

Methodology

Study Design

Study Design

Study Design

  •  A two-arm, single-blinded, randomized controlled trial design on  adult everyday smokers (at least 1    cigarette per day on average and  have smoked at least 100 cigarettes).

Side Sites

Study Design

Study Design

Mumbai, Pune, Kolkata and Mangalore

Duration

Study Design

Sample Size & Randomisation

One Year.

Sample Size & Randomisation

Sample Size & Randomisation

Sample Size & Randomisation

  • Minimum sample size: 500
  • Assuming about 40% drop out of 200 participants we will enroll 700 participants across all centres.
  • Computer generated randomization.
  • An open list of random numbers will be assigned to the participants.

Groups/ Arms

Sample Size & Randomisation

Type of Study

  • Minimum 250 participants each in Intervention Group (IG) and Control Group (CG).
  • Total minimum 500 participants will be included in the study. Assuming there will be about 40%
  • drop out, we will enroll about 700 participants in order to achieve the test and control
  • size of 350 in each arm, minimum target being 250 in total excluding the dropouts.

Type of Study

Sample Size & Randomisation

Type of Study

  • Eligible participants will be  randomly assigned to either do the QuitSure    program [the IG] or will simply be given brief advice to quit  smoking [the    CG]. 
  • Both point prevalence (PPA) abstinence and  prolonged abstinence (PA)    outcomes will be recorded via  self-reporting via phone, online, or in-person at the 7-day, 30-day,  3-month, and 6-month time points post the quit date (in the case of  the IG) or post the quit date defined in by the CG.
  • At the 30-day and  6- month time points we will also biochemically verify self-reported  data    by testing saliva cotinine (non-invasive test) in the  participants.

Blinding

Inclusion Criteria

Inclusion Criteria

Participant Blinded. The instruction given to the participant 

Inclusion Criteria

Inclusion Criteria

Inclusion Criteria

  • Smokes at least 1 cigarette per day on average and has smoked at least 100 cigarettes till date.
  • Agrees to participate in a smoking cessation treatment program with written informed consent.
  • Must be an adult over 18 years of age.
  • Are, at minimum, proficient in the written and spoken English Language.
  • Must be an everyday smoker: Should currently smoke 01 (one) or more cigarettes per day on an average (indicating sufficient dependence on nicotine)
    and have smoked at least 100 cigarettes (indicating sufficient exposure of the
    body to nicotine) on a regular basis.
  • Have daily access to an Android or iOS smartphone.
  • Salivary cotinine test positive on the first visit.
  • Can use a smartphone without difficulty.
  • Rinsed mouth thoroughly with water 10 minutes before sample is collected.
  • Inclusion criteria for controls: Age and gender matched controls.

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

  • Has already quit smoking and is currently not smoking.
    If a doctor has advised the participant not to quit cold-turkey.
  • History of severe mental illness/ psychiatric illness or under current treatment for psychiatric illness such as schizophrenia or other primary psychotic disorders, BPAD, catatonia, OCD, dissociative disorders, eating disorders,
    personality disorders.
  • Unable to attend follow-up clinic visits during the study period.
  • Started taking a smoking cessation medication within 1 year before the
    registration.
  • Planned to use any smoking cessation aids and/or to participate in any kind of smoking-cessation activities (not limited to smoking cessation therapy) outside
    of the trial.
  • Consumed a major meal within 60 minutes before the test.
  • Consumed alcohol within 12 hours before the test.
  • Consumed foods like broccoli, cabbage, mustard, garlic, radishes, almonds and
    horseradish within 12 hours.
  • Persons working with metal, the related occupations include electroplaters and
    people who refine precious metals.
  • Tobacco workers.

Protocol

Patient Information Sheet

Exclusion Criteria

  • Protocol Means how the study will be conducted uniformly across all centres keeping study design and enrollment same.

Click here to view the study protocol

Patient Information Sheet

Patient Information Sheet

Patient Information Sheet

  • Based on interview with participants and aafter taking consent from the participants, a form will be filled to register the details of the participants. 
  • This data remains with the admin panel and filled in a digital way as well as physically by taking print outs of the same. 
  • In case of poor internet connectivity or inability of the interviewer/ researcher to use the digital form, a physical form will also be kept stand by to register the data and upload them while internet connectivity is restored.

Click here to download the Patient Information Sheet

Consent form

Patient Information Sheet

Patient Information Sheet

  • All participants will be given printed consent form and the content of the same will be well explained by the researchers. 
  • Participation in the trial is voluntary and a participant even after giving informed consent can opt out of the study and the same will be noted as intention to treat analysis.

Click here to download the consent form

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