NCT05855512

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

February 3, 2023

Last Update Submit

May 3, 2023

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Number of times visited emergency due to asthma in last 4 weeks

    4 weeks

Study Arms (2)

Controlled group

NO INTERVENTION

No intervention was given, only the material was provided in the form of a booklet

Interventional Group

EXPERIMENTAL

The nursing educational intervention sessions were conducted, and the material was provided in the form of a booklet

Other: Nursing Educational Intervention

Interventions

Nursing Educational InterventionOTHER

Nursing Educational Intervention

Interventional Group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Chronic respiratory illnesses like T.B. cystitis and fibrosis.
  • Sinusitis,
  • Gastrointestinal reflux disease,
  • Rhinitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Civil Hospital

Karachi, Sindh, 74800, Pakistan

Location

Study Officials

  • Waqas Farooqi, PhD

    Dow University of Health Sciences Karachi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention and control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

May 11, 2023

Study Start

July 27, 2020

Primary Completion

November 10, 2020

Study Completion

December 12, 2020

Last Updated

May 11, 2023

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)