Impact of Nurse-led Intervention on Asthma Control in Children

Asthma in Children Clinical Trial

Official title:

Impact of Nurse-led Intervention on Asthma Control in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05855512
• Other study ID #: 12/2017/12
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: August 2020
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized control trial design (RCT) study was conducted on children aged 6 -11 years

Description:

This randomized control trial design study was conducted on children aged 6 -11 years, visiting the pediatric outpatient department and emergency at Dr. Ruth Pfau Civil Hospital Karachi.

For the experimental group, a nursing educational intervention session was conducted with the patient and family/caregiver by the principal investigator, and a doctor provided the usual care/treatment. In contrast, the control group received only the usual care/treatment provided by the doctor.

For the control group, educational material on asthma was provided in a booklet according to Global Initiative of Asthma (GINA) guidelines. Pre Childhood-Asthma Control Test (C-ACT) score of participants was measured before the intervention, and post-C-ACT score measurement was made after one month using the same questionnaires and C-ACT tool.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 12, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• Children between the aged 6 to 11 years

• Have asthma diagnosed by a physician at least 6-month back

• Uncontrolled asthma based on C-ACT score 19 or less 19.

Exclusion Criteria:

• Chronic respiratory illnesses like T.B. cystitis and fibrosis.

• Sinusitis,

• Gastrointestinal reflux disease,

• Rhinitis

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• Nursing Educational Intervention
Nursing Educational Intervention

Locations

Country	Name	City	State
Pakistan	Civil Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Childhood asthma control test (C-ACT) Score	C-ACT Score was measured in both controlled and intervention groups and compared the difference between pre-intervention and post-intervention	4 weeks
Primary	Number of times got Admissions due to asthma in the last 4 weeks	Using the same questionnaire number of admissions was compared to the difference between pre-intervention and post-intervention by the mean and standard deviation	4 weeks
Secondary	Number of times visited emergency due to asthma in last 4 weeks	Using the same questionnaire number of admissions was compared to the difference between pre-intervention and post-intervention by the mean and standard deviation	4 weeks