Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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20 September 2021 |
Main ID: |
ISRCTN11154315 |
Date of registration:
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15/05/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy of a smoking cessation intervention using smartphones
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Scientific title:
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Efficacy of a randomized controlled trial to promote smoking cessation using mobile applications |
Date of first enrolment:
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15/04/2018 |
Target sample size:
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240 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN11154315 |
Study type:
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Interventional |
Study design:
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Single-blind two-arm parallel-group randomized controlled trial with longitudinal design (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Philipp
Schwaninger |
Address:
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University of Zurich
Binzmühlestrasse 14 / 14
8050
Zürich
Switzerland |
Telephone:
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+41 44 635 72 25 |
Email:
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philipp.schwaninger@uzh.ch |
Affiliation:
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Telephone:
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Key inclusion & exclusion criteria
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Inclusion criteria: Adult smoker: 1. 18 years or older 2. Daily smoker (at least one cigarette per day) 3. Intention to quit smoking 4. Own a smartphone with access to mobile internet and daily use 5. Fluent in the German language
Buddies: 1. 18 years or older 2. Current non-smoker (at least 6 months abstinence of tobacco and e-cigarettes) 3. Own a smartphone with access to mobile internet and daily use 4. Fluent in the German language
Exclusion criteria: Adult smoker: 1. Younger than 18 years old 2. Less than daily smoking 3. 24-hour shift work 4. Simultaneous participation in a professional smoking cessation program or active use of a smoking cessation application 5. Insufficient comprehension of the German language.
Buddies: 1. Current smoker 2. 24-hour shift work 3. Younger than 18 years old 4. Insufficient comprehension of the German language
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Smoking cessation Mental and Behavioural Disorders Smoking cessation
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Intervention(s)
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Participants are randomly allocated to the intervention or control group. All participants attend a "background assessment" session at the University of Zurich. They are instructed to use a breathalyzer to measure exhaled carbon monoxide, and are instructed to announce a self-quit date. All participants receive an end of day diary (short questionnaire) which is filled out daily from 7 days before their quit date until 21 days after their quit date, and a breathalyzer to measure carbon monoxide output daily during this period. Participants are also followed up with a daily diary for three days, six months after their quit date.
Participants in the intervention group are additionally instructed to use the “SmokeFree Buddy app” during 28 consecutive days (7 days prior to the quit date and 21 days afterwards). More information on the “SmokeFree Buddy app”: https://www.smokefree.ch/en/buddy-app/ With the SmokeFree Buddy app participants also have to identify a personal buddy (self-chosen from the personal social network). These buddies get an instruction on how to connect with the target person and to use the “SmokeFree Buddy app“ during the 28 consecutive days to support the smoker in his/her cessation process.
Participants in the control group will have the same setting, but do not receive the mobile intervention “SmokeFree Buddy app” and therefore do not have a supporting buddy.
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Primary Outcome(s)
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1. Smoking abstinence is measured daily during the 28 day quitting period and for a three day period six months after the quit date, using 1.1. Subjective self reporting (daily diary questionnaires) of abstinence and and number of cigarettes smoked 1.2. Objective exhaled carbon monoxide (in parts per million [ppm]) via Smokerlyzer (iCO Smokerlyzer; Bedfont Scientific Ltd)
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Secondary Outcome(s)
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1. Intensity and quality of social support is measured daily using self-reporting diary questionnaires throughout the 28 day quitting period and for three days six months after the quit date. 2. Self-efficacy and action control is measured daily using self-reporting diary questionnaires throughout the 28 day quitting period and for three days six months after the quit date. 3. Positive and negative effect is measured daily using self-reporting diary questionnaires throughout the 28 day quitting period and for three days six months after the quit date.
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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Universität Zürich
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Ethics review
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Status:
Approval date:
Contact:
Ethics Committee of the Faculty of Arts and Social Sciences of the University of Zurich, 13/12/2017, ref: 17.12.13
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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20/03/2020 |
URL:
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