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CTRI Number  CTRI/2025/10/095547 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening 
Study Design  Other 
Public Title of Study   Can Village Health Volunteers (ASHAs) screen and Community health officers diagnose the diseases, namely Asthma and COPD, in the rural population above 30 years? (The SHVASAN Study) 
Scientific Title of Study   Implementation and feasibility of Screening by accredited social Health activist and diagnosis by Community Health Officers of Asthma and Chronic Obstructive Pulmonary Diseases(COPD) at the primary health care System: A novel strategy 
Trial Acronym  SHVASAN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwini Devane 
Designation  Senior Research Scientist I 
Affiliation  Central Research and Publication Unit(CRPU),Bharati Vidyapeeth Medical College,Pune 
Address  Room No 934, Central Research and Publication Unit(CRPU) 9th floor, Super-specialty Building Bharati Vidyapeeth (Deemed University) Medical College and Hospital, off Pune Satara Road, Dhankwadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9923607578  
Fax    
Email  ashwinidevane29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Jayashree Gothankar 
Designation  Incharge- Research, Central Research and Publication Unit (CRPU) and Professor Community Medicine, Bharati Vidyapeeth DU Medical College Pune  
Affiliation  Incharge- Research, Central Research and Publication Unit (CRPU) and Professor Community Medicine, Bharati Vidyapeeth DU Medical College Pune  
Address  Room No 934, Central Research and Publication Unit(CRPU) 9th floor, Super-specialty Building Bharati Vidyapeeth (Deemed University) Medical College and Hospital, off Pune Satara Road, Dhankwadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  0200-24055555 Ext-3909  
Fax    
Email  Jayashree.Gothankar@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  Dr.Jayashree Gothankar 
Designation  Professor and In-charge Research (CRPU) 
Affiliation  Incharge- Research, Central Research and Publication Unit (CRPU) and Professor Community Medicine, Bharati Vidyapeeth DU Medical College Pune  
Address  Room No 934, Central Research and Publication Unit(CRPU) 9th floor, Super-specialty Building Bharati Vidyapeeth (Deemed University) Medical College and Hospital, off Pune Satara Road, Dhankwadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9923607578  
Fax    
Email  Jayashree.Gothankar@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  V.Ramlingaswami BHavan,P.OBox No. 4911 Ansari Nagar,New Delhi-110029,India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ashwini Devane  Central Research and Publication Unit(CRPU), Bharati Vidyapeeth (DU) Medical College and Hospital  Room No 934, Central Research and Publication Unit(CRPU) 9th floor Super-specialty Building Bharati Vidyapeeth (Deemed University) Medical College and Hospital, off Pune Satara Road, Dhankwadi, Pune 411043
Pune
MAHARASHTRA 
09923607578

ashwinidevane29@gmail.com 
Dr Asim Khwaja  Primary Health centre Male  At Post Male PHC Primary Health Centre Male near Riverpalace hotel Tal Mulshi Dist Pune 412108
Pune
MAHARASHTRA 
91 99708 02401

mophcmale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
BharatiVidyapeeth(Deemed to be University) Medical Collge, Pune satara Road, Institutional Ethics Committee)  Approved 
NOC from PHC  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Chronic Obstructive Pulmonary Disease and Asthma 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  o compare the proportion of COPD and Asthma diagnosed cases among the population aged 30 years and above in one year in the implementing PHC and the adjacent PHC  1. Comparative analysis for prevalence at the implementation of PHC and adjacent PHC 2. Qualitative interviews based on the feasibility measures  
Intervention  Screening and Diagnosis for COPD and Asthma at at the primary health care   Screening by Accredited Social Health Activist (ASHAs)and diagnosis by Community Health officers of Asthma and COPD at the primary health care System. To compare the proportion of COPD and Asthma diagnosed cases among the population aged 30 years and above in one year in the implementing PHC and the adjacent PHC 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults above 30 years, Ready to consent, Implementation stakeholders ready to consent 
 
ExclusionCriteria 
Details  Terminally Ill Individuals 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Feasibility Index to measure the feasibility of screening by ASHAs and diagnosis by CHOs of COPD AND Asthma at Primary health care
2. Facilitators and operational challenges of the Implementation of the SHVASAN model at the primary care health care level among the rural adult population aged 30 years and above in one year of the implementation
 
At the end of the second year of the implementation of the SHVASAN model  
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of COPD & Asthma among adults aged 30 years & above in one year in the implementing PHC & the adjacent PHC
2. Early diagnosis of COPD & Asthma through community screening by ASHAs among adults aged 30 years & above in one year in the implementing PHC & the adjacent PHC
3. Policy Recommendations for better implementation of the government guidelines
 
At the end of the first year of the implementation of the SHVASAN model, & at the end of the second year of the implementation  
 
Target Sample Size   Total Sample Size="8836"
Sample Size from India="8836" 
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)   15/10/2025 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  ashwinidevane29@gmail.com

  6. For how long will this data be available start date provided 05-03-2026 and end date provided 31-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Implementation and Feasibility of ‘Screening by Accredited Social Health Activist and diagnosis by Community Health Officers of Asthma and COPD at the primary health care System: A Novel strategy- SHVASAN’

BVDUMC/IEC/317/25-26

Background

Given the substantial disease burden and Disability-Adjusted Life Years (DALYs) attributed to common chronic respiratory diseases, COPD and Asthma (CRDs) in India, there is an imperative to prioritize early intervention. Prompt attention to CRDs can mitigate the progression to advanced morbidity, avert premature recourse to tertiary care, and reduce economic losses due to decreased productivity and high out-of-pocket health expenditures. Early detection is contingent upon effective screening and diagnosis mechanisms. Despite the fact that CRDs predominantly affect individuals over the age of 40, current service delivery is inadequate: access to diagnostic tools such as spirometry remains largely limited to tertiary care facilities, both public and private. Furthermore, the use of spirometry is constrained by challenges related to technical training, participant cooperation, and financial barriers. Consequently, many individuals only seek care when symptoms such as a persistent cough and breathlessness become severe and unmanageable.

Rationale

The Peak Expiratory Flow Rate (PEFR) method has demonstrated effectiveness in diagnosing conditions such as COPD and asthma, particularly in resource-limited settings. Therefore, decentralizing screening and diagnostic services to locations more proximate to the patient population emerges as a logical strategy for facilitating early detection. The extant scientific literature provides substantial evidence to support the hypothesis that a structured implementation model integrating community-based screening by Accredited Social Health Activists (ASHAs) using peak flow meters, alongside diagnostic confirmation at Health and Wellness Centres (HWCs) via spirometry can enhance early detection and contribute to the strengthening of primary health care guidelines for COPD and asthma management. Although current CRD guidelines at the primary care level offer a supportive framework for such an intervention, the proposed model is poised to provide greater accessibility compared to existing approaches. With guidelines in place yet a lack of clear implementation strategies at the ground level, the present moment offers a timely and strategic opportunity to rigorously explore the feasibility of this model.

Accordingly, it is justified to undertake a study examining the feasibility, including both facilitators and operational challenges, of implementing such a screening and diagnostic pathway at the primary health care level. This research will generate critical evidence to inform the development of implementation strategies as public health services prepare for broader rollout in the near future. Evidence-based policy recommendations stemming from this work will be pivotal in ensuring high-quality care for CRD screening and diagnosis at the primary health care level, preceding full-scale implementation.

The development and application of a Feasibility Index in this context represents a novel scientific contribution, enabling the quantification of implementation feasibility and potentially informing future innovations in this area, particularly as implementation plans transition from design to practice.

Accordingly, I propose the introduction and real-world testing of a novel comprehensive implementation model, “SHVASAN,” to assess its feasibility through systematic identification of facilitators and operational challenges.

Title and Objectives

Implementation and Feasibility of Screening by Accredited Social Health Activist (ASHAs)and diagnosis by Community Health officers of Asthma and COPD at the primary health care System- A Novel Strategy- SHVASAN

Primary objective -

To assess the feasibility of implementation of a “SHVASAN “model for screening and diagnosis of COPD and Asthma at the primary health care level

Secondary objective (s)-

1.     To implement the ‘SHVASAN’ model for screening and diagnosis of COPD and Asthma at the primary health care level.

2.     To determine the facilitators and operational challenges in the implementation of the ‘SHVASAN’ model for screening and diagnosis of COPD and Asthma at the primary health care level.

3.     To compare the proportion of COPD and Asthma diagnosed cases among the population aged 30 years and above in one year in the implementing PHC and the adjacent PHC

 

Research Question (RQs)

1.     What is the extent of feasibility of implementation of the SHVASAN model at the primary care health care level among the rural adult population aged 30 years and above in one year of the implementation?

2.      What are the facilitators and operational challenges of the Implementation of the ‘SHVASAN’ model at the primary care health care level among the rural adult population aged 30 years and above in one year of the implementation?

3.     What is the difference in the proportion of chronic respiratory disease (CRD) diagnosed among adults aged 30 years and above in one year in the implementing PHC and the adjacent PHC?

 
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