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The Impact of Indoor Environmental Quality on Symptoms in Patients With Chronic Obstructive Pulmonary Disease

ConditionsCOPD (Chronic Obstructive Pulmonary Disease)Acute Exacerbation of COPD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZiekenhuis Oost-Limburg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Wearable mobile device

    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.

  • Indoor environmental quality sensor

    Device

    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.

  • CAT Questionnaire

    Other intervention

    A COPD Assessment Test questionnaire will be taken during the hospitalization (start of the study), and weekly after discharge.

  • PSQI Questionnaire

    Other intervention

    A Pittsburgh Sleep Quality Index questionnaire will be taken 4 weeks after hospital discharge (end of the study).

  • KSS Questionnaire

    Other intervention

    A Karolinska Sleepiness Scale questionnaire will be taken daily after discharge.

  • SQS Questionnaire

    Other intervention

    A sleep quality scale questionnaire will be taken daily after discharge.

  • PROMs Questionnaire

    Other intervention

    A PROMs questionnaire will be taken daily after discharge.

  • eHLQ Questionnaire

    Other intervention

    An eHealth literacy questionnaire will be taken during the hospitalization (start of the study), and 4 weeks after hospital discharge (end of the study).

  • Housing Questionnaire

    Other intervention

    A housing questionnaire will be taken during the hospitalization (start of the study).

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Patients admitted with an acute COPD exacerbationExperimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Weekly score of COPD symptom burden assessed using the COPD Assessment Test (CAT)

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.

Time frame
Baseline and weekly during the 1-month follow-up
2

Weekly mean PM0.5 concentration

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.

Time frame
Weekly during the 1-month follow-up
3

Weekly mean PM2.5 concentration

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.

Time frame
Weekly during the 1-month follow-up
4

Weekly mean PM4 concentration

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.

Time frame
Weekly during the 1-month follow-up

Secondary outcomes

1

Feasibility - Measurement completeness

Proportion of expected IEQ measurements successfully recorded.

Time frame
During follow-up (1 month)
2

Feasibility - Valid monitoring time

Duration of valid monitoring time per participant.

Time frame
During follow-up (1 month)
3

Daily perceived change in health status

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.

Time frame
Daily during follow-up (1 month)
4

Feasibility - Frequency of data gaps

Frequency of gaps in monitoring data.

Time frame
During follow-up (1 month)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ziekenhuis Oost-Limburg

Lead sponsor

Maastricht University

Collaborator

University of Liege

Collaborator

Hasselt University

Collaborator

KU Leuven

Collaborator

Source ClinicalTrials.gov

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