Pragmatic Clinical Trial to Demonstrate Positive Healthcare Effects of the Digital Health Application Eila® as a Means to Treat Nicotine Addiction (Protocol Number X9001304)

Pfizer Pharma GmbH0 个研究点目标入组 1,000 人开始时间: 2022年1月27日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

•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.

发起方