Asthma in Children Clinical Trial
— ELIPSE-IIOfficial title:
Early Life Intervention in Pediatrics Supported by E-health (ELIPSE II): Coaching Parents to Lower Second-hand Smoke Exposure in Children A Single-blind Randomized Controlled Parallel-group Clinical Trial
NCT number | NCT06311162 |
Other study ID # | 2023-01615 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2024 |
Est. completion date | July 31, 2028 |
Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .
Status | Recruiting |
Enrollment | 160 |
Est. completion date | July 31, 2028 |
Est. primary completion date | August 31, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 5 Years |
Eligibility | Inclusion Criteria: - Age: younger than 6 years - Exposed to second-hand smoke at home (at least one parent smoking) - German speaking parent - All sex and ethnic backgrounds - Signed informed consent form from parent - Children live/grow-up in the same household as the parental participant - Referred by a health care professional (e.g. physician, midwife, nurse, other professions) Exclusion Criteria: - Participation in another study/trial targeting similar outcomes - Participation in an active smoking cessation programme |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Paediatrics, Inselspital, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern | University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acceptance and usability of the app (parent reported outcome) | The usability of the app is assessed using the eHealth App Usability Questionnaire (MAUQ). The questionnaire measures usability on three subscales (ease of use, Interface and satisfaction, usefulness). The MAUQ questionnaire consists of 18 items with a score ranging from 1 to 7. Score 7 means a better result. | At 22 weeks after baseline (Post intervention) | |
Other | Acceptance of the app | The acceptance of the app is measured by means of dropout rate. | During the intervention (week 2-22) | |
Other | Usability of the app | The usability of the app is measured by means of how often and how long the parents use the app. | During the intervention (week 2-22) | |
Other | Number of episodes of airway disease in children | Parents are asked to report any event of airway disease (including any type of upper or lower respiratory tract infection; e.g. otitis media, rhinitis, pharyngitis, acute or chronic bronchitis, protracted bacterial bronchitis, chronic cough, pneumonia). | Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline | |
Other | Frequency of inhalant medications or antibiotics required for airway disease in children | Parents are asked to report any medical treatment received because of airway disease (includes inhalant drugs, antibiotics, antipyretic medication). | Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline | |
Other | Amount of inhalant medications or antibiotics required for airway disease in children | Parents are asked to report any medical treatment received because of airway disease (includes inhalant drugs, antibiotics, antipyretic medication). | Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline | |
Other | Number of episodes of severe airway disease in children requiring hospitalization | Parents are asked about any hospitalization because of airway disease. | Baseline, during the intervention (week 2-22), at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline | |
Other | Change from baseline in parental smoking intensity (number of cigarettes smoked per day) | Parents are asked to report their smoking habits (using a questionnaire). | At 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline | |
Primary | Change from baseline in urinary levels of cotinine in children | Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine | At 22 weeks after baseline (Post intervention) | |
Primary | Change from baseline in urinary levels of cotinine in children | Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine | At 48 weeks after baseline (Follow-Up) | |
Secondary | Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure | Parents are asked (using a questionnaire) about the measures taken to protect children from second-hand smoke exposure at baseline, during the intervention, postintervention and follow-up. Protective measures assessed include washing hands, smoking outside (including not smoking in the car), changing clothes after smoking). The questionnaire consists of five items (protective measures) with a score ranging from 1 to 5. Score 5 means a better result. | During intervention (week 2-22), post intervention (week 22-23) and follow-up (week 48-49) |
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