F17
Conditions
Interventions
Group 1: Use of the Eila app for smoking cessation over a period of 25 weeks. The app should be used on a regular basis (weekly).
Group 2: Patients are treated according to the Standard of Care. They
Sponsors
Pfizer Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants are at least 18 years old. 2. Participants are nicotine-dependent (in accordance with ICD-10 F17.2); i.e., they smoke at least one cigarette per day 3. Participants are willing to stop smoking. 4. Participants have an Eila®-compatible device at their disposition. 5. Participants have a valid private email address. 6. Participants are willing to use the app Eila® independently on a regular basis. 7. Participants have a primary residence in the Federal Republic of Germany.
Exclusion criteria
Exclusion criteria: Medical Conditions: 1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. Prior/Concurrent Clinical Study Experience: 2. Participants were administered and/or are still using an investigational drug to treat nicotine addiction within 30 days prior to inclusion in this study. 3. Participants have received and/or are still using a software medical device to treat nicotine dependence prior to inclusion in this study. Other Exclusions: 4. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. 5. Participants do not have sufficient knowledge of the German language necessary to participate in the study. 6. Participants work 24h shifts (e.g., ambulance service, fire department) which prevent continuous participation in the study. 7. Participants are not willing to answer questions related to the study on a weekly basis over a period of 25 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-day point-prevalence of smoking abstinence at week 25 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction of nicotine dependence symptoms due to smoking (measured by the FTCD score) 2. Prolonged Abstinence from smoking (analysed using generalized linear mixed models) 3. Cessation of Smoking: Proportion of participants experiencing at least one cessation (i.e., non-smoking for at least 4 weeks) 4. Nicotine Withdrawal symptoms (measured by the Minnesota Tobacco Withdrawal Scale score) 5. Cigarette Consumption: derived from the number of consumed cigarettes during the last week 6. Time to Minor/Major Relapse: measured as time from quitting smoking to the occurrence of a minor/major relapse during the 25 weeks 7. Well-being: measured by the WHO-5 score 8. Cotinine level: cotinine levels in urine 9. Presence of depressed mood and generalized anxiety: measured by PHQ-4 | — |
Countries
Germany
Contacts
Public ContactThomas Hering
Lungenarztpraxis Tegel
Outcome results
None listed