Clinical trial NCT05630599: Remote Assessment of Lung Disease and Impact on Physical and Mental Health
Official title: Remote Assessment of Lung Disease and Impact on Physical and Mental Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Covid19
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2022-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diagnosis of IPF, COPD and COVID-19. Subjects that fit the in/exclusion criteria will be identified from the respiratory outpatients clinics at the UCLH and RFH

Brief summary: This cohort study aims to use the open-source RADAR-base mHealth platform to collect and analyze datasets associated with lung disease. This will include continuous data collected from wearable devices (e.g. heart rate, oxygen saturation, respiratory rate), including pulse oximeters, spirometer, mobile phones, digital tests, and smart phone symptom questionnaires.


Eligibility criteria: Inclusion Criteria:

* 20 patients with a diagnosis of COPD
* 20 patients with a diagnosis of interstitial lung disease
* 20 a clinical diagnosis of COVID-19 (within 4-13 weeks of enrolment) who either and report symptoms interfering with day to day activity present for more than 28 days following the onset of COVID-19
* Prior mobile phone use
* Willingness to use monitoring devices and complete study questionnaires.
* History of exacerbation (COPD: 2 or more exacerbations in last 1 yr)

Exclusion Criteria:

* Non English language Speaker
* Lack of physical capability to take part e.g. Heart Failure
* Pregnancy
* Lack of capability to consent

Primary outcomes:
measure: The feasibility of remote monitoring of patient symptoms and physiology using commercially available wearable sensors and questionnaires in patients with lung disease.
timeFrame: 6 months
measure: Acceptability of remote monitoring system in patients with lung disease.
timeFrame: 6 months
measure: Quantification of symptoms using various symptom questionnaires and scales.
timeFrame: 6 months
measure: Report longitudinal mental health symptoms measures as reported by GAD7 and PHQ8 associated with the three diseases.
timeFrame: 6 months
measure: Fatigue is the major reported symptom for those experiencing "long COVID". A range of modalities for evaluating fatigue are included 1) Garmin Body Battery value and 2) Fatigue Severity Scale (FSS), continuous/weekly respectively, duration of study
timeFrame: 6 months
measure: The assessment of novel phone based tests (Audio, Breathing Tests see: non-questionnaire Active App tests) for remote monitoring of respiratory health.
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants that experience one exacerbation within the stopping criteria for each group
timeFrame: 6 months
measure: Establish whether subclinical exacerbations can be identified in patients with lung fibrosis, and if exacerbations can be detected earlier with home monitoring.
timeFrame: 6 months
Other outcomes:
measure: Provide data for power calculations for a follow on study.
timeFrame: 6 months
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: King's College London
name: Amos Folarin
role: STUDY_DIRECTOR
affiliation: University College, London
name: John Hurst
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Joanna Porter
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Malik Althobiani
role: STUDY_CHAIR
affiliation: King's College London
name: Yatharth Ranjan
role: STUDY_CHAIR
References:
citation: Ranjan Y, Althobiani M, Jacob J, Orini M, Dobson RJ, Porter J, Hurst J, Folarin AA. Remote Assessment of Lung Disease and Impact on Physical and Mental Health (RALPMH): Protocol for a Prospective Observational Study. JMIR Res Protoc. 2021 Oct 7;10(10):e28873. doi: 10.2196/28873.