| 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
|
|
|
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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - ashwinidevane29@gmail.com
- 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.
- 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’ 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. 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? |