Remote Assessment of Lung Disease and Impact on Physical and Mental Health

NCT ID: NCT05630599

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-26

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Interstitial Lung Disease Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ILD

ILD, or lung fibrosis, is one of a spectrum of fibrotic diseases, associated with ageing, obesity, diabetes and pollution, that are responsible for \~45% of premature deaths in Western Europe. Of \>90,000 patients in the United Kingdom with ILD, \~30,000 have idiopathic pulmonary fibrosis, idiopathic pulmonary fibrosis, the most severe form. idiopathic pulmonary fibrosis is a disease of unknown aetiology that is more frequent in males presenting mainly in the sixth and seventh decades of life. There is no cure and median survival, just 3-5 years following diagnosis is worse than for many cancers.

No interventions assigned to this group

COPD

COPD is a common, long term condition of the lungs that is usually caused by cigarette smoking. In addition to daily symptoms and limitations in activities, patients are prone to developing chest infections called 'exacerbations'. Exacerbations are a significant problem: unpleasant for patients, and sometimes severe enough to cause hospital admission (and therefore National Health Service pressures) and death.

No interventions assigned to this group

COVID-19

Recovery from COVID19 has many unknowns, especially in the long term. Symptoms of COVID-19 have varied among those who have tested positive: some have displayed no symptoms, while others have developed severe pneumonia, progressing to lung injury and acute respiratory distress syndrome (ARDS) and, in the longer term, pulmonary fibrosis. Notably, the consequences of COVID-19 include effects on other organs including: heart, kidneys, and brain.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amos Folarin

Role: STUDY_DIRECTOR

King's College London

John Hurst

Role: PRINCIPAL_INVESTIGATOR

University College, London

Joanna Porter

Role: PRINCIPAL_INVESTIGATOR

University College, London

Malik Althobiani

Role: STUDY_CHAIR

University College, London

Yatharth Ranjan

Role: STUDY_CHAIR

King's College London

Locations

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Royal Free Hospital

London, , United Kingdom

Site Status

University College London Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 34319235 (View on PubMed)

Other Identifiers

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274070

Identifier Type: -

Identifier Source: org_study_id

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