跳至主要内容
临床试验/CTRI/2025/10/095547
CTRI/2025/10/095547尚未招募不适用

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

Indian Council of Medical Research2 个研究点 分布在 1 个国家目标入组 8,836 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
8,836
试验地点
2
主要终点
1. Feasibility Index to measure the feasibility of screening by ASHAs and diagnosis by CHOs of COPD AND Asthma at Primary health care

研究概览

简要总结

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 ObjectivesImplementation 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?

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adults above 30 years, Ready to consent, Implementation stakeholders ready to consent.

排除标准

  • Terminally Ill Individuals.

结局指标

主要结局

1. Feasibility Index to measure the feasibility of screening by ASHAs and diagnosis by CHOs of COPD AND Asthma at Primary health care

时间窗: At the end of the second year of the implementation of the SHVASAN model

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

时间窗: At the end of the second year of the implementation of the SHVASAN model

次要结局

  • 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)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Ashwini Devane

Central Research and Publication Unit(CRPU),Bharati Vidyapeeth Medical College,Pune

研究点 (2)

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