Impact of Nurse-led Intervention on Asthma Control in Children

May 3, 2023 updated by: Dow University of Health Sciences
This randomized control trial design (RCT) study was conducted on children aged 6 -11 years

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Civil Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controlled group
No intervention was given, only the material was provided in the form of a booklet
Experimental: Interventional Group
The nursing educational intervention sessions were conducted, and the material was provided in the form of a booklet
Other: Nursing Educational Intervention
Nursing Educational Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childhood asthma control test (C-ACT) Score
Time Frame: 4 weeks
C-ACT Score was measured in both controlled and intervention groups and compared the difference between pre-intervention and post-intervention
4 weeks
Number of times got Admissions due to asthma in the last 4 weeks
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of times visited emergency due to asthma in last 4 weeks
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Study Director: Waqas Farooqi, PhD, Dow University of Health Sciences Karachi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2020

Primary Completion (Actual)

November 10, 2020

Study Completion (Actual)

December 12, 2020

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/2017/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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