Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421402
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-20
First Post:
2024-04-29
Brief Title:
K-HEALTH in AIR - Barcelona Pilot - Cohort
Sponsor:
Institut dInvestigacions Biomèdiques August Pi i Sunyer
Organization:
Institut dInvestigacions Biomèdiques August Pi i Sunyer
Study Overview
Official Title:
Knowledge for Improving Indoor Air Quality and Health Follow up of 200 High-risk Chronic Respiratory Patients During 24 Months
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 scalabilitytransferability of the new integrated care service
PHASE I 2024
1 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
2 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
3 Advanced Digital Support to innovative clinical processes with a two-fold aim i patients empowerment for self-management of hisher 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 andor specialist To this end adoption of an Adaptive Case Management ACM Approach constitutes a key element
4 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 Patients 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
PHASE II 2025
From January to December 2025 two additional PDSA cycles six-month duration each are planned to cover the following objectives
1 Refinement of the novel integrated care service for enhanced management of exacerbations as well as the implementation and continuous assessment of the four core components described in PHASE I
2 Assessment of the outcomes of the novel integrated care service using the Quintuple Aim framework that is considering i Healthcare outcomes ii PROMsPatient Reported Expirence Measures PREMs iii healthcare professionals engagement iv operational costs and v assessing equity Comparison with conventional care will be done using a propensity score matching to elaborate a control group
3 Evaluation of the process of deployment of the service using the Consolidated Framework for Implementation Research CFIR to identify barriersfacilitators for achieving a sustainable adoption target candidates for the novel service as well as potential for service transferability to other sites
At the end of PHASE II a mature service design ready for adoption should be available Besides fulfilment of the objectives of K-Health in Air the key lessons learned in the two-years period should provide novel insights for enhanced management of chronic patients with multimorbid conditions
Enclosed find i the Patients Informed Consent approved by the Ethics Committee as well as ii the study protocol approved by the Ethics Committee of the Hosptial Clínic de Barcelona HCB-2023-0126
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 scalabilitytransferability of the new integrated care service
PHASE I 2024
1 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
2 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
3 Advanced Digital Support to innovative clinical processes with a two-fold aim i patients empowerment for self-management of hisher 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 andor specialist To this end adoption of an Adaptive Case Management ACM Approach constitutes a key element
4 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 Patients 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
PHASE II 2025
From January to December 2025 two additional PDSA cycles six-month duration each are planned to cover the following objectives
1 Refinement of the novel integrated care service for enhanced management of exacerbations as well as the implementation and continuous assessment of the four core components described in PHASE I
2 Assessment of the outcomes of the novel integrated care service using the Quintuple Aim framework that is considering i Healthcare outcomes ii PROMsPatient Reported Expirence Measures PREMs iii healthcare professionals engagement iv operational costs and v assessing equity Comparison with conventional care will be done using a propensity score matching to elaborate a control group
3 Evaluation of the process of deployment of the service using the Consolidated Framework for Implementation Research CFIR to identify barriersfacilitators for achieving a sustainable adoption target candidates for the novel service as well as potential for service transferability to other sites
At the end of PHASE II a mature service design ready for adoption should be available Besides fulfilment of the objectives of K-Health in Air the key lessons learned in the two-years period should provide novel insights for enhanced management of chronic patients with multimorbid conditions
Enclosed find i the Patients Informed Consent approved by the Ethics Committee as well as ii the study protocol approved by the Ethics Committee of the Hosptial Clínic de Barcelona HCB-2023-0126
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 101057693 | OTHER_GRANT | HaDEA | None |