| CTRI Number |
CTRI/2025/09/094060 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of giving education to children with asthma along with medicine. |
|
Scientific Title of Study
|
Effectiveness of Multimodal Educational Program [MEP] on asthma control, quality of life and medication adherence in asthma management among children diagnosed with asthma: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
REMIYA MOHAN |
| Designation |
ASSISTANT PROFESSOR, COLLEGE OF NURSING |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
| Address |
COLLEGE OF NURSING, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003991316 |
| Fax |
|
| Email |
mohanr@aiimsjodhpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MUKESH CHANDRA SHARMA |
| Designation |
ASSOCIATE PROFESSOR, COLLEGE OF NURSING |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
| Address |
COLLEGE OF NURSING, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003991316 |
| Fax |
|
| Email |
sharmamc@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
REMIYA MOHAN |
| Designation |
ASSISTANT PROFESSOR, COLLEGE OF NURSING |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
| Address |
COLLEGE OF NURSING, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR
RAJASTHAN
342005
India |
| Phone |
8003991316 |
| Fax |
|
| Email |
mohanr@aiimsjodhpur.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ms REMIYA MOHAN |
| Address |
COLLEGE OF NURSING, AIIMS, JODHPUR |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| REMIYA MOHAN |
Room No: 225; PFT Room, PEDIATRIC OPD |
AIIMS, JODHPUR
Jodhpur
RAJASTHAN |
8003991316
mohanr@aiimsjodhpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS,JODHPUR, INSTITUTIONAL ETHICS COMMITTEE (Clinical Trial) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J45||Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multimodal Educational Program [MEP] |
In addition to routine asthma care, the interventional group will receive Multimodal Educational Program [MEP] for the management of asthma.
The session will be conducted in groups of approximately 5 parent-child dyads by the Principal Investigator [PI] and each session will be of approximate one hour. This will be based on ASSURE Model. The ASSURE model, an acronym for Analyze learners, State objectives, Select media and materials, Utilize materials, Require learner performance, and Evaluate/revise the learning and teaching process, is presented to assist nurses in organizing the process of patient education.
MEP session will be of approximate 1 hour. Experimental group will be telephonically followed up weekly for first month and thereafter monthly.
|
| Comparator Agent |
Routine treatment of asthma and health education |
The control group will receive routine treatment and health education. Data on quality of life and medication adherence will be collected at baseline, one month, and three months by the data collector. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Child-parent dyad i.e. children who are accompanied by a parent
2. Known cases of Asthma for at least 3 months and on treatment OR Child having asthma symptoms for at least 3 months and diagnosed with Asthma
3. Child who are prescribed daily Inhaled Corticosteroid Therapy
4. Child and Parents who can understand English/Hindi language
5. Having access to smart mobile phone
6. Willingness to be part of study and follow-up
|
|
| ExclusionCriteria |
| Details |
1. Children with any other chronic co-morbidity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of a Multimodal Educational Program [MEP] on asthma control, quality of life, and medication adherence among children diagnosed with asthma. |
Baseline, 1 Month, 3 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between asthma control, quality of life, and medication adherence among children diagnosed with asthma. |
Baseline, 1 Month, 3 Month |
| To determine the association of asthma control, quality of life, and medication adherence with selected demographic variables among children diagnosed with Asthma. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/09/2025 |
| 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="2"
Months="0"
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
|
This is a Randomized Controlled Trial that aims to evaluate the impact of a Multimodal Educational Program [MEP] on asthma control, quality of life, and medication adherence among children diagnosed with asthma. The study will assess the correlation between asthma control, quality of life, and medication adherence and determine the association of asthma control, quality of life, and medication adherence with selected demographic variables. The study will include children coming to the Paediatric OPD of AIIMS Jodhpur aged between 7-15 years who are accompanied by a parent and will be prescribed Inhaled Corticosteroid Therapy (ICS). Approximate 80% of cases of poor adherence still occur due to improper inhaler technique and numerous studies show that one of the most important aspects of managing asthma is patient education. This study is planned considering the need and significance of educational interventions among children diagnosed with asthma which is crucial for keeping an eye on symptoms, controlling medication to prevent attacks, and responding to issues related to asthma. |