Early Life Intervention in Pediatrics Supported by E-health - SMOKE

Asthma in Children Clinical Trial

— ELIPSE-II  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06311162
• Other study ID #: 2023-01615
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: March 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Matthias V. Kopp, Prof. Dr.
• Phone: +41 31 66 4 13 51
• Email: matthias.kopp[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Description:

ELIPSE-II represents a single-blind randomized controlled parallel-group clinical trial. In total, 160 children, <6 years of age with exposure to second-hand smoke at home will be included. Children will be recruited at the children's university hospital and in private practices in Bern, and randomly (1:1) assigned to a control and intervention group. All participants receive treatment-as-usual (TAU), parents of participants in the intervention group additionally receive a smartphone application (lifestyle app) for 20 weeks. The app aims to promote healthy behavior through cognitive-behavioral impact factors (i.e., psychoeducation, goal setting), that are applied by a psychologist via structured feedback. Single-blinded assessments will be conducted at baseline, following the intervention period of 20 weeks, and at 6-month follow-up after the end of the intervention. The primary endpoint is reduction of exposure to second-hand smoke exposure assessed by urinary levels of cotinine. Secondary endpoints in ELIPSE-II include changes in parental smoking habits and effects of the intervention on infants' respiratory health. A further endpoint is acceptance and usability of the app.

Recruitment information / eligibility

• Status: Not yet 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

Related Conditions & MeSH terms

• Asthma in Children
• Behavior, Smoking
• Life Style
• Non-Communicable Disease
• Noncommunicable Diseases
• Respiratory Sounds
• Smoking Reduction
• Wheezing

Intervention

Behavioral:
• Life-Style app
The modules of the Life-Style app are introduced and unlocked sequentially during the first weeks of the intervention phase. Afterwards the modules are fully available. Duration and frequency of app-use is not limited. The parents are accompanied by a coach through the app, who gives regular structured feedback and individual inputs. The coach has access to all data collected in the app.

Other:
• Sham Comparator
The parents get a flyer with information on second-hand smoke exposure and references to smoking cessation programs, and do not have an active app during the main intervention period.

Locations

Country	Name	City	State
Switzerland	Department of Paediatrics, Inselspital, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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)