Acute Exacerbation of COPD, COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
Mobile health, COPD, Remote monitoring, AECOPD, Air quality, Environmental quality, Indoor air quality
Brief summary
This prospective, monocenter pilot study will investigate the relationship between indoor environmental quality (including air quality, lighting, noise, and thermal conditions), wearable-derived health insights, and patient-reported symptoms in patients recovering at home after hospitalization for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Participants will undergo continuous monitoring of indoor environmental conditions and health parameters using a Garmin Venu 4 smartwatch, together with validated questionnaires assessing COPD symptoms, sleep quality, and daytime sleepiness during one month. The study will assess the feasibility and potential added value of high-resolution home monitoring and explore whether environmental and wearable-derived measures are associated with symptom burden and early signs of clinical deterioration following hospital discharge. The investigators hypothesize that continuous in-home monitoring of indoor environmental quality is feasible and provides clinically relevant insights into symptom burden in recently hospitalized COPD patients. The primary objective is to determine the correlation between indoor environmental quality (IEQ) variables and symptom burden in COPD patients following hospitalization for AECOPD.
Detailed description
Patients hospitalized for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) remain highly vulnerable after discharge, with persistent symptom burden and an increased risk of early recurrent exacerbations. During this post-hospitalization period, patients spend most of their time indoors, making indoor environmental quality (IEQ, including air quality, lighting, noise and thermal aspects) a potentially important and modifiable determinant of recovery. For example, exposure to particulate matter (PM) has been associated with airway inflammation, symptom worsening, and increased exacerbation risk in COPD. However, evidence on continuously measured IEQ at home and its relationship with symptoms after hospitalization for acute exacerbation of COPD remains limited. Recent advances in wearable technology allow continuous monitoring of health insights in real-world settings. Prior studies have demonstrated the feasibility of wearable devices in patients with COPD and suggest that changes in activity, heart rate, and sleep may precede clinical deterioration or exacerbations. Integrating continuous IEQ monitoring with wearable-derived health insights (i.e., from a Garmin Venu 4 watch) and validated patient-reported outcomes, such as the widely used COPD Assessment Test (CAT), Pittsburgh Sleep Quality Index (PSQI), Karolinska Sleepiness Scale (KSS), Sleep Quality Scale (SQS), may improve understanding of symptom dynamics, uncover risk factors, and identify early indicators of worsening disease. This prospective monocenter pilot study aims to explore these relationships and to assess the feasibility and added value of high-resolution IEQ monitoring in the home setting of recently hospitalized COPD patients.
Interventions
DEVICEWearable mobile device
Patients admitted due to an acute COPD exacerbation will be asked to wear the wearable mobile device for a period of one month after hospital discharge. An app linked to the device will be installed on their phone, and used to send health insights to the investigators.
DEVICEIndoor environmental quality sensor
When the participants are discharged home, an indoor environmental quality sensor will be installed in the patient's home. One sensor will be installed in the bedroom, one in the living room or kitchen (wherever the patient spends the most time). Data from these sensors will be sent to the hub (placed central between the sensors) and thereafter, to the investigators. The sensors measure particulate matter concentrations, CO2 concentrations, VOC concentrations, temperature, relative humidity, ambient light, and ambient noise.
OTHERCAT Questionnaire
A COPD Assessment Test questionnaire will be taken during the hospitalization (start of the study), and weekly after discharge.
OTHERPSQI Questionnaire
A Pittsburgh Sleep Quality Index questionnaire will be taken 4 weeks after hospital discharge (end of the study).
OTHERKSS Questionnaire
A Karolinska Sleepiness Scale questionnaire will be taken daily after discharge.
OTHERSQS Questionnaire
A sleep quality scale questionnaire will be taken daily after discharge.
OTHERPROMs Questionnaire
A PROMs questionnaire will be taken daily after discharge.
OTHEReHLQ Questionnaire
An eHealth literacy questionnaire will be taken during the hospitalization (start of the study), and 4 weeks after hospital discharge (end of the study).
OTHERHousing Questionnaire
A housing questionnaire will be taken during the hospitalization (start of the study).
Sponsors
Ziekenhuis Oost-Limburg
Maastricht University
University of Liege
Hasselt University
KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide signed and dated informed consent * Adults older than 18 years of age * Previously diagnosed with COPD according to GOLD guidelines * Hospitalization due to AECOPD * Spend \>50% of time indoor at home * Speak and understand the Dutch language
Exclusion criteria
* Previous diagnosis of asthma * (History of) chronic macrolide use (\> 3 months) * Living in institution or residential care center * Estimated life expectancy of less than 6 months * Not in the possession of a smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly mean PM0.5 concentration | Weekly during the 1-month follow-up | Indoor PM0.5 concentration (µg/m³) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week will be aggregated to calculate a weekly mean PM0.5 concentration. |
| Weekly score of COPD symptom burden assessed using the COPD Assessment Test (CAT) | Baseline and weekly during the 1-month follow-up | COPD symptom burden will be assessed using the COPD Assessment Test (CAT). The CAT is an 8-item questionnaire with a total score ranging from 0 to 40 points, with higher scores indicating greater COPD symptom burden and a greater impact of COPD on daily life. |
| Weekly mean VOC concentration | Weekly during the 1-month follow-up | Indoor volatile organic compound (VOC) concentration (ppb) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week will be aggregated to calculate a weekly mean VOC concentration. |
| Weekly mean temperature | Weekly during the 1-month follow-up | Indoor temperature concentration (°C) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week will be aggregated to calculate a weekly mean temperature. |
| Weekly mean relative humidity | Weekly during the 1-month follow-up | Indoor relative humidity (%) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week will be aggregated to calculate a weekly mean relative humidity. |
| Weekly mean ambient light - day | Weekly during the 1-month follow-up | Indoor ambient light (lux) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week during day-time hours will be aggregated to calculate a weekly mean ambient light - day. |
| Weekly mean ambient light - night | Weekly during the 1-month follow-up | Indoor ambient light (lux) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week during night-time hours will be aggregated to calculate a weekly mean ambient light - night. |
| Weekly mean ambient noise - night | Weekly during the 1-month follow-up | Indoor ambient noise (dB) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week during night-time hours will be aggregated to calculate a weekly mean ambient noise - night. |
| Weekly overall proportion of time with at least one IEQ threshold violated | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which at least one predefined indoor environmental quality (IEQ) threshold is violated. IEQ variables will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, the IEQ variables will be compared with their respective predefined thresholds. The proportion of monitoring time points at which at least one IEQ threshold is violated will be calculated for each week. |
| Weekly mean PM4 concentration | Weekly during the 1-month follow-up | Indoor PM4 concentration (µg/m³) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week will be aggregated to calculate a weekly mean PM4 concentration. |
| Weekly mean PM10 concentration | Weekly during the 1-month follow-up | Indoor PM10 concentration (µg/m³) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week will be aggregated to calculate a weekly mean PM10 concentration. |
| Weekly mean CO2 concentration | Weekly during the 1-month follow-up | Indoor CO2 concentration (ppm) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week will be aggregated to calculate a weekly mean CO2 concentration. |
| Weekly mean PM2.5 concentration | Weekly during the 1-month follow-up | Indoor PM2.5 concentration (µg/m³) will be measured at 15-minute intervals in the participant's home during the 1-month follow-up. The measurements collected during each week will be aggregated to calculate a weekly mean PM2.5 concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wearable-derived sleep metrics - Sleep duration | Nightly during the 1-month follow-up | Nightly sleep duration (hours) measured using the wearable. |
| Wearable-derived sleep metrics - Sleep score | Nightly during the 1-month follow-up | Nightly sleep score measured using the wearable. Score from 0-100, with a higher score indicating better quality of sleep. |
| Wearable-derived sleep metrics - Time in sleep cycle | Nightly during the 1-month follow-up | Nightly time spent in REM, deep, and light sleep (hours). |
| Wearable-derived physical activity - Daily step count | Daily during the 1-month follow-up | Daily step count (number) measured by the wearable. |
| Wearable-derived physical activity - Activity minutes | Daily during the 1-month follow-up | Daily activity minutes (minutes) measured by the wearable. |
| Concentration of outside air quality | During follow-up (1 month) | Concentration of outside air quality measure (PM, expressed in µg/m³) based on the participant's residential area. |
| COPD exacerbations | During follow-up (1 month) | Occurrence of a COPD exacerbation during the follow-up period. |
| eHealth literacy | Baseline and end of study (one month) | eHealth Literacy Questionnaire (eHLQ) domain scores describing participants' strengths and needs related to eHealth literacy. The eHLQ consists of 35 items across 7 domains. Each domain is scored from 1 to 4 points, with higher scores indicating a greater level of the characteristic assessed by the respective domain. |
| Change in eHealth literacy | Baseline and end of study (one month) | Change in eHealth literacy from baseline to the end of the 1-month follow-up, assessed using the eHealth Literacy Questionnaire (eHLQ). The eHLQ consists of 35 items across 7 domains. Each domain is scored from 1 to 4 points. Higher scores indicate a greater level of the characteristic assessed by the respective domain. Change in each domain score from baseline to 1 month will be calculated. |
| Housing characteristics | Baseline | Sociodemographic characteristics, housing characteristics, and indoor environmental factors assessed using the Housing Conditions Questionnaire. |
| Weekly overall proportion of time with PM0.5 threshold exceeded | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which PM0.5 threshold is exceeded. PM0.5 will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, PM0.5 will be compared with its respective predefined threshold. The proportion of monitoring time points at which PM0.5 is exceeded will be calculated for each week. |
| Weekly overall proportion of time with PM1 threshold exceeded | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which PM1 threshold is exceeded. PM1 will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, PM1 will be compared with its respective predefined threshold. The proportion of monitoring time points at which PM1 is exceeded will be calculated for each week. |
| Weekly overall proportion of time with PM2.5 threshold exceeded | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which PM2.5 threshold is exceeded. PM2.5 will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, PM2.5 will be compared with its respective predefined threshold. The proportion of monitoring time points at which PM2.5 is exceeded will be calculated for each week. |
| Weekly overall proportion of time with PM4 threshold exceeded | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which PM4 threshold is exceeded. PM4 will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, PM4 will be compared with its respective predefined threshold. The proportion of monitoring time points at which PM4 is exceeded will be calculated for each week. |
| Weekly overall proportion of time with PM10 threshold exceeded | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which PM10 threshold is exceeded. PM10 will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, PM10 will be compared with its respective predefined threshold. The proportion of monitoring time points at which PM10 is exceeded will be calculated for each week. |
| Weekly overall proportion of time with CO2 threshold exceeded | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which the CO2 threshold is exceeded. CO2 will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, CO2 will be compared with its respective predefined threshold. The proportion of monitoring time points at which CO2 is exceeded will be calculated for each week. |
| Weekly overall proportion of time with VOC threshold exceeded | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which the VOC threshold is exceeded. VOC will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, VOC will be compared with its respective predefined threshold. The proportion of monitoring time points at which VOC is exceeded will be calculated for each week. |
| Weekly overall proportion of time with temperature threshold violated | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which the temperature threshold is violated. The temperature will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, the temperature will be compared with its respective predefined threshold. The proportion of monitoring time points at which the temperature is violated will be calculated for each week. |
| Weekly overall proportion of time with the relative humidity threshold violated | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which the relative humidity threshold is violated. The relative humidity will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, the relative humidity will be compared with its respective predefined threshold. The proportion of monitoring time points at which the relative humidity is violated will be calculated for each week. |
| Weekly overall proportion of time with ambient light (day) threshold violated | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which the ambient light threshold is violated during the day-time hours. The ambient light will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, ambient light will be compared with its respective predefined threshold. The proportion of monitoring time points at which ambient light is violated during the day-time hours will be calculated for each week. |
| Weekly overall proportion of time with ambient light (night) threshold violated | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which the ambient light threshold is violated during the night-time hours. The ambient light will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, ambient light will be compared with its respective predefined threshold. The proportion of monitoring time points at which ambient light is violated during the night-time hours will be calculated for each week. |
| Weekly overall proportion of time with the ambient noise (night) threshold exceeded | Weekly during the 1-month follow-up | Overall proportion of monitoring time per week during which the ambient noise threshold is exceeded during night-time hours. The ambient noise will be monitored at predefined measurement intervals during the 1-month follow-up. For each measurement time point, the ambient noise will be compared with its respective predefined threshold. The proportion of monitoring time points at which ambient noise is exceeded during night-time hours will be calculated for each week. |
| Feasibility - Measurement completeness | During follow-up (1 month) | Proportion of expected IEQ measurements successfully recorded. |
| Feasibility - Valid monitoring time | During follow-up (1 month) | Duration of valid monitoring time per participant. |
| Daily perceived change in health status | Daily during follow-up (1 month) | Patient-reported change in overall health status compared with the previous day, assessed using a single question: "How is your health today compared with yesterday?" Participants will select one of three response options: better, about the same, or worse. |
| Feasibility - Frequency of data gaps | During follow-up (1 month) | Frequency of gaps in monitoring data. |
| Feasibility - Duration of data gaps | During follow-up (1 month) | Duration of gaps in monitoring data. |
| Wearable-derived health insights - Heart rate | Continuous monitoring during follow-up (1 month) | Heart rate (BPM) measured using the wearable. |
| Wearable-derived health insights - Respiratory rate | Continuous monitoring during follow-up (1 month) | Respiratory rate (BPM) measured using the wearable. |
| Wearable-derived health insights - Oxygen saturation | Continuous monitoring during follow-up (1 month) | Oxygen saturation (%) measured using the wearable. |
| Wearable-derived health insights - Skin temperature | Continuous monitoring during follow-up (1 month) | Nightly deviation in skin temperature (°C) compared with the previous night, measured using the wearable. |
| Sleep quality - PSQI | End of study (one month) | Pittsburgh Sleep Quality Index (PSQI) assessing subjective sleep quality over the preceding month. The PSQI total score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality. |
| Sleepiness - KSS | Daily during the 1-month follow-up | Karolinska Sleepiness Scale (KSS) assessing subjective sleepiness at a specific time point. The KSS score ranges from 1 to 9 points, with higher scores indicating greater subjective sleepiness. |
| Sleep quality - SQS | Daily during the 1-month follow-up | Single-item Sleep Quality Scale (SQS) assessing perceived sleep quality of the previous night. The SQS score ranges from 0 to 10 points, with higher scores indicating better perceived sleep quality. |
Countries
Belgium
Contacts
CONTACTRuben Knevels, MsC
CONTACTFemke Wouters, PhD
PRINCIPAL_INVESTIGATORDavid Ruttens, MD, PhD
Ziekenhuis Oost-Limburg
Outcome results
None listed