Asthma in ChildrenNCT05855512
Impact of Nurse-led Intervention on Asthma Control in Children
A study testing Nursing Educational Intervention in people with Asthma in Children, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This randomized control trial design (RCT) study was conducted on children aged 6 -11 years Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Nursing Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Jul 2020to 12 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Chronic respiratory illnesses like T.B. cystitis and fibrosis.
- Sinusitis,
- Gastrointestinal reflux disease,
- Rhinitis
Trial locations and contacts
1 site in 1 country.
About this study
This randomized control trial design (RCT) study was conducted on children aged 6 -11 years
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Nursing Educational Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Educational InterventionOther
Nursing Educational Intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nursing Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 weeks
Secondary outcomes (1)
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start27 Jul 2020
- Primary completion10 Nov 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqas Farooqi, PhD, Study director, Dow University of Health Sciences Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855512
- Sponsor's protocol ID
- 12/2017/12
- Status last verified
- Aug 2020
- First submitted
- 3 Feb 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nurse-led Intervention on Asthma Control in Children
- ClinicalTrials.gov ID
- NCT05855512
- Acronym / sponsor ID
- 12/2017/12
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized control trial design (RCT) study was conducted on children aged 6 -11 years
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Controlled group | No intervention | –No intervention was given, only the material was provided in the form of a booklet |
| Interventional Group | Experimental | Other: Nursing Educational InterventionThe nursing educational intervention sessions were conducted, and the material was provided in the form of a booklet |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Chronic respiratory illnesses like T.B. cystitis and fibrosis.
- Sinusitis,
- Gastrointestinal reflux disease,
- Rhinitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing Educational InterventionNursing Educational Intervention | Other | Interventional Group |
Primary outcome
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
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
1 secondary outcome
Number of times visited emergency due to asthma in last 4 weeks
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waqas Farooqi, PhD study director
Dow University of Health Sciences Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Educational Intervention in people with Asthma in Children, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood asthma control test (C-ACT) Score (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.