| CTRI Number |
CTRI/2024/05/067113 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Teaching parents of kids with asthma how to use inhalers better with a structured program |
|
Scientific Title of Study
|
Asthma inhaler technique education in parents of asthmatic children by structured education program |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha |
| Designation |
Post-graduate |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8431570431 |
| Fax |
|
| Email |
anusha.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Purkayastha |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Paediatrics
MAHE,KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886249133 |
| Fax |
|
| Email |
jaya.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashree Purkayastha |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Paediatrics
MAHE,KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886249133 |
| Fax |
|
| Email |
jaya.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Manipal
|
|
|
Primary Sponsor
|
| Name |
Anusha |
| Address |
Department of Respiratory Therapy, Manipal College of Health Professions, Manipal-576104 |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayashree Purkayastha |
Kasturba Hospital |
Clinical demonstration room
Room-3
Out patient department
Department of paediatrics
Ground floor
Kasturba Hospital
Manipal
Udupi
KARNATAKA |
9886249133
jaya.p@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of asthmatic child |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational Intervention |
Intervention duration is 8 months
No treatment
No drugs used in the study |
| Comparator Agent |
Not applicable |
Not applicable
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Parents with asthmatic child of 5-12 years of age who are on regular MDI use with or without spacer |
|
| ExclusionCriteria |
| Details |
Parents with asthmatic children less than 5 years and more than 12 years of age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant improvement in the knowledge level and skills are assessed through structured education program based on cut off value |
It is a pre-post study so baseline scores are assessed and structured education given, After ten minutes post test scores are assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Inhaler technique proficiency is a critical factor influencing the success of asthma therapy, as inadequate administration of medication may lead to poor disease control and increased healthcare utilization. Sometimes, people might have wrong ideas about how to use inhalers, so it’s crucial to clear up any confusion. This study enhancing asthma inhaler technique education among parents of asthmatic children. Aiming to evaluate the effectiveness of an educational intervention on improving inhaler technique proficiency among parents of asthmatic children , with the goal of enhancing overall asthma management and patient outcomes. The ultimate goal is to empower parents to become active partners in the management of their child’s asthma, It positively impacts the long-term health and well-being of asthmatic children. |