Knowledge for Improving Indoor Air Quality and Health: Follow up of 200 High-risk Chronic Respiratory Patients During 24 Months.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in use of healthcare resources - Unplanned hospital admissions
研究概览
简要总结
The study protocol is part of the European (EU) project "Knowledge for improving indoor AIR quality and HEALTH" (K-HEALTHinAIR, 2022-2026 - registry 101057693), which focuses on enhancing our understanding of how poor indoor air quality (IAQ) affects human health. Specifically, the project aims to identify IAQ determinants of adverse health events and to explore the development of cost-effective strategies for the precise monitoring and improvement, of IAQ across Europe.
With the current study protocol, the Barcelona Pilot, at the Integrated Health District of Barcelona-Esquerra (AISBE, 520 k citizens), is conducting a cohort study over a two-year period (January 2024 to December 2025) to explore the relationships between IAQ (assessment of chemical pollutants in patients' homes) and health status (acute episodes) in multimorbid patients with chronic respiratory diseases (asthma and Chronic Obstructive Pulmonary Disease - COPD) over a two-year period.
The protocol investigates the effectiveness of customized interventions across four critical areas: i) Advanced lung function testing, ii) Continuous IAQ monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modeling for early identification and management of exacerbations. The ultimate objective is to design and evaluate an innovative integrated care service aiming at enhancing both IAQ and the management of multimorbid patients with chronic obstructive respiratory diseases, with focus on COPD and severe asthma.
详细描述
The study is structured as a comprehensive two-phase approach. From January to December 2024 (Phase I) the protocol focuses on the assessment, and refinement, of the four core components of the study: i) Enhanced lung function testing, ii) IAQ home monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modelling for early detection and management of exacerbations. The main outcome at the end of Phase I is the design of an innovative integrated care service aiming at enhanced management of exacerbations and reduction of unplanned hospitalizations in high-risk patients.
From January to December 2025 (Phase II), the protocol aims to refine the novel clinical process, including the four core components alluded to above, as well as to evaluate the potential for healthcare value generation and scalability/transferability of the new integrated care service.
PHASE I (2024):
- Enhanced Lung Function Testing: Adoption of oscillometry (forced oscillation technique) to measure respiratory system resistance and reactance, as a complementary tool of forced spirometry, exploring its potential for patients' monitoring and management of exacerbations.
- Continuous Monitoring of IAQ at patients' homes: Assessment of advanced monitoring systems in patients' homes to continuously track air quality parameters, enabling the identification of environmental triggers linked to respiratory exacerbations.
- Advanced Digital Support to innovative clinical processes with a two-fold aim: i) patient's empowerment for self-management of his/her condition, and ii) enhancing the role of the nurse case manager for early detection and management of exacerbations promoting share care agreements between the patient and the reference doctor (primary care physician and/or specialist). To this end, adoption of an Adaptive Case Management (ACM) Approach constitutes a key element.
- Predictive Modeling: Development, and refinement, of machine learning-based modelling for early detection and management exacerbations. Key input data in the modelling approach will be: i) Clinical information (symptoms, Patient Reported Outcome Measures - PROMs), ii) Lung function testing, and iii) Patient's self-capturing physiological data through wrist sensors (health rate, heart rate variability and physical activity). Moreover, the impact of IAQ monitoring in the modelling will be explored.
The implementation, and refinement, of the four components alluded to above, as well as the design of the novel integrated care service, will be done with active engagement of patients, healthcare professionals, and other stakeholders in a co-design process using the Plan-Do-Study-Act (PDSA) methodology. Two PDSA cycles, with a six-month duration each, will be undertaken during 2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 85 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged Maximum 85 years
- •Diagnosed with chronic obstructive pulmonary conditions such as COPD or treatment-resistant asthma.
- •Exhibiting a high burden of co-morbidities, assessed above the 80th percentile of the regional risk stratification pyramid using Adjusted Morbidity Groups (AMG) scoring.
- •Residing in Barcelona-Esquerra, except for treatment-resistant asthma patients, live in any district of the city of Barcelona.
排除标准
- •Dementia.
- •Inability to perform independent daily activities.
结局指标
主要结局
Changes in use of healthcare resources - Unplanned hospital admissions
时间窗: During 2025
Number of unplanned hospital admissions. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Changes in use of healthcare resources - Emergency room visits
时间窗: During 2025
Number of emergency room visits. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Changes in use of healthcare resources - Exacerbations
时间窗: During 2025
Number and severity of exacerbations. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Changes in use of healthcare resources - Primary care visits.
时间窗: During 2025
Number of primary care visits. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
次要结局
- Patient reported experience (PREMs) - Physiological wellbeing(During 2025)
- Patient reported experience (PREMs) - Person-centeredness(During 2025)
- Patient reported experience (PREMs) - Social Participation(During 2025)
- Healthcare costs(During 2025)
- Patient reported experience (PREMs) - Enjoyment of life(During 2025)
- Patient reported experience (PREMs) - Resilience(During 2025)
- Patient reported experience (PREMs) - Physical functioning(During 2025)
- Patient reported experience (PREMs) - Continuity of care(During 2025)
- Patient reported outcomes (PROMs) - Dyspnea(During 2025)
- Patient reported outcomes (PROMs) - Asthma symptoms(During 2025)
- Patient reported outcomes (PROMs) - Functional problems related to asthma(During 2025)
- Patient reported outcomes (PROMs) - COPD symptoms(During 2025)
- Performance of the digital support in terms of robustness and usability - Usability(During 2025)
- Patient reported outcomes (PROMs) - Sino-Nasal symptoms(During 2025)
- Patient reported outcomes (PROMs) - Adherence to inhalers(During 2025)
- Performance of Predictive Modeling for Enhanced Management of Exacerbations(During 2025)
- Equity of the intervention(During 2025)
- Performance of the digital support in terms of robustness and usability - Customer Satisfaction(During 2025)
研究者
Josep Roca Torrent
Principal Investigator
Institut d'Investigacions Biomèdiques August Pi i Sunyer
