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CTRI Number  CTRI/2025/03/081527 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Financial and social problems faced by the family of children with asthma  
Scientific Title of Study   Socioeconomic Burden Related to Pediatric Asthma Management on the Family in a Tertiary Care Public Hospital  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunil Karande 
Designation  Professor and Head of Department  
Affiliation  Seth G S Medical College and KEM Hospital  
Address  HOD Office Room Department of Pediatrics Seth G S Medical College and KEM Hospital Old KEM Hospital Building Ground floor Ward No 2 Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9322934309  
Fax    
Email  karandesunil@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Milind S Tullu 
Designation  Professor  
Affiliation  Seth G S Medical College and KEM Hospital  
Address  Professor room Department of Pediatrics Seth G S Medical College and KEM Hospital Old KEM Hospital Building Ground floor Ward No 1 Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9869469974  
Fax    
Email  milindtullu@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Akshata S Warad 
Designation  Junior Resident  
Affiliation  Seth G S Medical College and KEM Hospital  
Address  Resident room Department of Pediatrics Seth G S Medical College and KEM Hospital Old KEM Hospital Building Ground floor Ward No1 Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9620235327  
Fax    
Email  akshataswarad1234@gmail.com  
 
Source of Monetary or Material Support  
Seth G S Medical College and KEM Hospital Parel Mumbai 400012 Maharashtra 
 
Primary Sponsor  
Name  No Sponsor MD Dissertation  
Address  NOT APPLICABLE 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Milind S Tullu  Seth G.S. Medical College and KEM Hospital  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Ground Floor, Parel, Mumbai 400012, MAHARASHTRA, India
Mumbai
MAHARASHTRA 		 9869469974

milindtullu@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IEC III, Seth G S Medical College and KEM Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NOT APPLICABLE 
Comparator Agent  NIL  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All children aged 3-12 years attending Pediatric Chest Clinic(OPD) of KEM Hospital Mumbai will be enrolled  
 
ExclusionCriteria 
Details  Parent /guardian not willing for consent to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Estimate the socioeconomic burden of pediatric asthma management by estimating its direct indirect and intangible costs  Children with one year follow up in PCC(Pediatric Chest Clinic) OPD 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   24/03/2025 
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="1"
Months="6"
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  

Introduction:

Childhood asthma is a chronic inflammatory disorder of airways characterized by recurrent episodes of wheezing, breathlessness, chest tightness, and coughing and is triggered by factors such as viral infections, allergens, air pollution, physical activity and is driven by an immune response.

The inflammation leads to : 

Bronchoconstriction: Constriction of the bronchial muscles. 
Airway edema: Swelling of the airway walls. 
Mucus hypersecretion: Increased production of mucus which can obstruct the airways. These changes result in the typical symptoms of asthma i.e. wheezing, coughing, chest tightness, and shortness of breath. 

The common triggers for pediatric asthma include : 

Allergens: Pollen, dust mite, pet dander, and mold. 
Infections: Viral respiratory infections are a major cause of asthma exacerbations in children. 
Environmental factors: Tobacco smoke, air pollution, cold air, and exercise. 
Genetic factors: A family history of asthma or allergic diseases increases the risk of pediatric asthma.

Pharmacologic treatment used for asthma includes

1. Controller Medications : 
i. Inhaled Corticosteroids (ICS): First-line treatment to reduce airway inflammation. E.g. Budesonide, Beclamethasone, and Fluticasone. 
ii. Long acting Beta2 Agonists (LABAs): Often used in combination with ICS for persistent asthma. E.g. Formeterol and Salmeterol. 
iii. Leukotriene Modifiers: Alternatives or add ons to ICS for controlling inflammation. E.g. Montelukast and Zafirlukast.  
2. Reliever Medications : 
i. Short acting Beta2 Agonists (SABAs): Used for quick relief of acute symptoms. E.g. Salbutamol and Levosalbutamol.  
ii. Anticholinergics: May be used in combination with SABAs during acute exacerbations. E.g. Ipratropium and Tiotropium. 
3. Advanced Therapies : 

Biologics: Monoclonal antibodies (like Omalizumab) target specific pathways in severe asthma. 

Non Pharmacologic strategies used for treating pediatric asthma include :

1. Avoidance of triggers: Identifying and minimizing exposure to known allergens and irritants. 
2. Education: Teaching families and children about asthma management and the proper use of inhalers or other devices. 
3. Asthma action plan: A written plan developed by healthcare providers to guide patients in managing their asthma based on individual symptoms and peak flow readings in the patient.


Pediatric asthma is a chronic condition with prevalence of 1 to

18 percent of children globally, presenting a significant public health challenge with far reaching economic implications. The economic burden of pediatric asthma is multifaceted, encompassing direct, indirect and intangible costs. Direct costs include healthcare expenses such as hospitalisations, emergency room visits, outpatient consultations, medications, and medical supplies. Indirect costs arise from lost productivity of parents or caregivers who must miss work to care for their children, and long-term economic consequences linked to reduced educational attainment and sub-optimal quality of life in affected children. Intangible costs are related to the pain and suffering endured by patients leading to decline in their quality of life.  The alarming rise in pediatric asthma cases has led to increased utilisation of healthcare resources and escalated financial pressures on families and healthcare systems. According to a research conducted by Nurmagambetov et al. in the United States and  by Sennhauser FH et al. in Europe, hospitalisations  and  medications constituted the largest share of direct costs. The indirect costs are equally significant, as parents often face reduced work-productivity or job loss due to frequent absences needed to care for their children suffering from asthma, leading to substantial economic losses. The chronic nature of asthma also means that children with poorly controlled symptoms may experience frequent school absences, adversely affecting their educational outcomes and future earning potential. These indirect costs extend beyond immediate financial impacts, influencing broader socio-economic dimensions and quality of life.

Understanding and quantifying of the economic burden of pediatric asthma is essential for formulating effective public health policies and interventions. By consolidating the principles followed in estimating the socioeconomic burden from various previous studies, this research aims to present a detailed analysis of direct, indirect and intangible costs associated with pediatric asthma, not just on the family but also on the healthcare system. There is paucity of Indian studies evaluating the socioeconomic burden of pediatric asthma on the family and the healthcare system.8  Hence  this dissertation project has been conceived to study the socioeconomic burden of pediatric asthma on the family and the healthcare system in a tertiary care public hospital in an urban setting.  


Aim:

Primary aim:  To estimate the socioeconomic burden of pediatric asthma management by estimating its direct, indirect and intangible costs. 

Secondary aim: To assess the factors affecting the socioeconomic burden. 

 

Materials and Methods:

Ethics: The study will be initiated after seeking approval from the Institutional Ethics Committee (IEC) of the hospital. The study will be conducted in compliance with the Ethical Guidelines for Biomedical Research on Human Participants by the Indian Council of Medical Research. 

Consent and Assent: Case enrollment will be done after a written informed consent from the parent or guardian. Assent will be procured from children aged 7 years and above. 

Study design: Cross sectional, non-interventional, single center study. 

Study duration: The study will be conducted over a period of 18 months (prospectively) after approval from the IEC. 

Study site: The study will be conducted in patients attending Pediatric Chest Clinic (OPD) of KEM hospital, Mumbai, which is a tertiary care center. 

Inclusion Criteria: Children aged more than or equal to 3 years to up to 12 years diagnosed as asthma will be enrolled. Patients with a follow up of at least 1 year in the Pediatric Chest Clinic will be enrolled and information will be extracted from the OPD papers.  

Exclusion Criteria: Cases in which parent or guardian not willing for consent to participate in the study. 

Confidentiality: The participants details will not be disclosed at any point of time. 

Total number of patients to be studied (sample size calculation)

Convenience sample will be taken. PCC has an average of 30 enrollments per year, and follow up patients for at least 3 years (about 90 to100 patients). About 30 percent of these patients are below 3 years of age. Expected enrollment is 50.

 

Data Recording:

    Demographic and Socioeconomic data like age of child and parents, sex, per capita income of family, number of siblings, socioeconomic status according to modified Kuppuswamy scale, type of school, tuition and other extra-curricular activities will be recorded.

    Parents details like education, occupation, per capita income and type of family will be recorded.

Clinical data of the child: age of onset of symptoms, age of

diagnosis, severity of asthma, number of exacerbations or

EPR visits in last 1 year, medications details and device

details. 

A structured questionnaire will be used to interview the parent

or guardian to collect data on direct, indirect and intangible

costs.

Calculation of direct, indirect, intangible, average and total

costs in INR and US dollar will be done.

A. From the afflicted family’s perspective the costs calculated will be as follows

    1.  Direct costs:

  i. Direct medical costs: OPD registration fees, Bed charges (if admitted), Investigations, and Medications.

  ii. Direct non-medical costs: Travel expenses and Food  expenses.

2.  Indirect costs: Loss of earnings of parent or guardian, loss of job, and school absenteeism.

3.  Intangible costs: By documenting the parent or guardians 


willingness to pay value using the contingent valuation


technique. It is a recommended method in cost of illness 


studies that adopt a societal perspective.The parent will be provided with an initial bid namely, their per capita income to

minimise their starting bid bias and will be asked whether they would like to pay this amount of money as a one time payment for a remedy that would cure their childs asthma. If the parent answers positively then the amount will be increased i.e., doubled until the parent declines to (hypothetically) pay the specified amount. However, if the parent answers negatively then the amount will be decreased i.e., halved until the parent accepts to (hypothetically) pay the specified amount.

 

Plan for Statistical Analysis:

The following statistical tests will be applied for the various

variables and their analysis: Mean, Median, Mode. Used to

summarize central tendencies in cost data.

Standard Deviation and Variance: Measures of dispersion to

understand the variability in costs.  

Quantile regression model will be used to assess the impact of

variables on the costs.

Expected Outcomes:

This study will help in determination and evaluation of economic

costs of asthma and thereby may provide insights on better

planning and improving the infrastructure, for providing better

care to children with asthma and their families and evolve 

policies for reduction and control of disease. Implementation of

robust asthma management programs and policies can mitigate

these costs incurred to family and healthcare facility. Enhanced

preventive measures, better access to healthcare, and targeted

interventions can significantly reduce the financial and health

burden of pediatric asthma, ultimately leading to improved

health outcomes and economic benefits to society and

individuals.


References: 

1.  Liu AH, Bacharier LB, Fitzpatrick AM, Sicherer SH. Childhood Asthma. In: Kliegman RM, St Geme III JW, Blum NJ, Tasker RC, Wilson KM, Schuh AM, Mack CL, editors. Nelson Textbook  of  Pediatrics, 22nd ed. Philadelphia: Elsevier; 2023 p 1386-1410.  

2.  Global Initiative for Asthma. Global strategy for asthma management and prevention.2023 update.[Internet].Global Initiative for Asthma; 2023[cited 2024 Aug 20]. Available from: https://ginasthma.org

3.  Krahn MD, Berka C, Langlois P, Detsky AS. Direct and indirect costs of asthma in Canada, 1990. CMAJ 1996; 154:821-831.

4. Cohen AJ, Anderson HR, Brunekeef B, et al. The impact of asthma on healthcare utilization and costs in children: a systematic review. J Allergy Clin Immunol 2021;147:556564.

5. Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc 2018;15:348-356.

6. Sennhauser FH, Braun-Fahrländer C, Wildhaber JH. The burden of asthma in children: a European perspective. Paediatr Respir Rev 2005;6:2-7. 

7. Lodha R, Puranik M, Kattal N, Kabra SK. Social and economic impact of childhood asthma. Indian Pediatr 2003;40:874-879.

8. Lal A, Kumar L, Malhotra S. Socio-economic burden of childhood asthma. Indian Pediatr 1994;31:425-432. 

9. Daniel RA, Aggarwal P, Kalaivani M, Gupta SK. Prevalence of asthma among children in India: A  systematic review and meta-analysis. Lung India 2022;39:357-367.

10. Lahiri K, Najmuddin F. Correlation of financial burden with severity of asthma in children. Pediatric Rev Int J Pediatrics Res 2018;5:273-277.

11. Suárez-Varela MM, González AL, Martínez Selva MI. Socioeconomic risk factors in the prevalence of asthma and other atopic diseases in children 6 to 7 years old in Valencia, Spain. Eur J Epidemiol 1999;15:35-40.

12. Jo C. Cost-of-illness studies: concepts, scopes, and methods. Clin Mol Hepatol 2014; 20:327-337.

13. Karande S, Gogtay NJ, More T, Sholapurwala RF, Pandit S, Waghmare S. Economic burden of limited English proficiency: A prevalence-based cost of illness study of its direct, indirect and intangible costs. J Postgrad Med 2023;69:27-34.

14. Wu P, Xu B, Shen A, He Z, Zhang CJP, Ming WK, et al. The economic burden of medical treatment of children with asthma in China. BMC Pediatr 2020;20:386. 

 
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