The Invisible Trigger: A Quasi-Experimental Study on the... | NCT07069192

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Apr 1, 2025Actual

Completion Date

May 1, 2025Actual

First Submitted Date

Jul 7, 2025

First Submission Date that Met QC Criteria

Jul 7, 2025

First Posted Date

Jul 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2025

Last Update Posted Date

Jul 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ayesha Saeed, Public health Officer, Foundation University IslamabadPrincipal Investigator

Lead Sponsor

Foundation University IslamabadOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the effect of passive smoke exposure on childhood asthma and the role of structured counseling in reducing SHS exposure and improving asthma control.

Detailed Description

A quasi-experimental study conducted at Fauji Foundation Hospital using a pre-post test design. The intervention group received structured caregiver counseling about the dangers of passive smoking and asthma management. The study used ACT scores to assess improvement in asthma control.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	usual care without counselling
Counselling	Experimental	Counselling	Behavioral: Counselling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Counselling	Behavioral	Received structured caregiver counseling - weekly sessions for 1 month and biweekly for the next 2 months.	Counselling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Asthma control test (ACT) Score Improvement	Change in ACT Score from baseline to 3 months after intervention. ACT score of 19 is considered as normal Asthma control, less then 19 is considered as poor Asthma control and more than 19 ACT score is considered as good Asthma control	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed Asthma, Passive smoke exposure

Exclusion Criteria:

Comorbidity, sever asthma requiring hospitalisation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fauji Foundation Hospital, Rawalpindi		Rawalpindi	Punjab Province	44000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not Required

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Intervention Model Description

The primary purpose is to offer practical insights into reducing the burden of childhood asthma by fusing exposure reduction techniques with asthma management education. It is anticipated that the results will guide evidence-based policy and public health campaigns to lower exposure to SHS, improve asthma outcomes, and improve the lives of children with the condition.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services