Chronic Obstructive Pulmonary DiseaseRALPMHNCT05630599
Remote Assessment of Lung Disease and Impact on Physical and Mental Health
An observational study of Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by University College, London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Covid19
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 26 Jul 2021to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- Non English language Speaker
- Lack of physical capability to take part e.g. Heart Failure
- Pregnancy
- Lack of capability to consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Free Hospital
London
University College London Hospital
London
About this study
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.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of remote monitoring of patient symptoms and physiology using commercially available wearable sensors and questionnaires in patients with lung disease.
Feasibility will be measured by recruitment, retention rate, completion of data, and drop-out rates at end of the study. (e.g. participants screened for study eligibility and enrollment were documented. Also, reasons for non-participation and completion of the study were recorded). Compliance using components of the RADAR-base system.
Measured: 6 months
Acceptability of remote monitoring system in patients with lung disease.
TAM-FF: Measure the impact of the technology being used and evaluate its acceptability, usability and performance.
Measured: 6 months
Quantification of symptoms using various symptom questionnaires and scales.
- Epworth Sleepiness Scale (Used to diagnose obstructive sleep apnea(OSA).
- STOPBang Questionnaire (Used to diagnose obstructive sleep apnea(OSA).)
- MRC Breathlessness (Dyspnoea scale that evaluates theimpact of breathlessness on daily activity)
- St. George's Respiratory Questionnaire (SGRQ)
- Pittsburgh Sleep Quality Index (PSQI) Sleep scoring questionnaire
- Visual Analogue Scale (VAS) Cough
Measured: 6 months
Report longitudinal mental health symptoms measures as reported by GAD7 and PHQ8 associated with the three diseases.
Impact of disease on mood and wellbeing and quality of life using generalised anxiety disorder assessment (GAD-7) from 0 to 21, and depression scale of the Patient Health Questionnaire (PHQ8), weekly for 6 months.
Measured: 6 months
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
- Fatigue Severity Scale (FSS) is A 9-item questionnaire used to measure fatigue in people with chronic diseases.
- Garmin Body Battery value from the wearable (Garmin, Vivoactive 4). It uses activity, heart rate, and stress to estimate participant energy.
Measured: 6 months
The assessment of novel phone based tests (Audio, Breathing Tests see: non-questionnaire Active App tests) for remote monitoring of respiratory health.
The ubiquity of smartphones presents an opportunity to use the phone itself as a health measuring tool for both applications. Active audio tasks such as pronouncing sustained vowels or counting from 1 to 20 will provide additional information on voice production dynamics that might be affected by lung disorder symptoms.Voice production tasks via the phone. These tasks will assess change in the phonatory respiratory system
Measured: 6 months
Secondary outcomes (2)
Number of participants that experience one exacerbation within the stopping criteria for each group
Number of exacerbations that were detected by i) home-based spirometry ii) patient-reported outcome measure using mobile questionnaire iii) wearable data (Vivoactive 4).
Measured: 6 months
Establish whether subclinical exacerbations can be identified in patients with lung fibrosis, and if exacerbations can be detected earlier with home monitoring.
Detecting exacerbation/symptom e.g. changes in wearable data (e.g. HR, SpO2, Activity) during the reported period of exacerbation( A real-time algorithm will be included to predict exacerbations with patients notified with the Exacerbation Rating Scale (ERS) to confirm the prediction at or close to the time of the event), detecting exacerbation prior to or after the reported period of exacerbation (e.g. signal that may precede participant awareness of the exacerbation/symptom), detecting subclinical exacerbations in patients with lung fibrosis, tracking self-reported symptoms and outcomes (including precursors presymptomatic signal) and their frequency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start26 Jul 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Amos Folarin, Study director, King's College LondonJohn Hurst, Principal investigator, University College, LondonJoanna Porter, Principal investigator, University College, LondonMalik Althobiani, Study chair, University College, LondonYatharth Ranjan, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630599
- Sponsor's protocol ID
- 274070
- Acronym
- RALPMH
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34319235
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Assessment of Lung Disease and Impact on Physical and Mental Health
- ClinicalTrials.gov ID
- NCT05630599
- Acronym / sponsor ID
- RALPMH / 274070
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Non English language Speaker
- Lack of physical capability to take part e.g. Heart Failure
- Pregnancy
- Lack of capability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The feasibility of remote monitoring of patient symptoms and physiology using commercially available wearable sensors and questionnaires in patients with lung disease.
Time frame: 6 months
Feasibility will be measured by recruitment, retention rate, completion of data, and drop-out rates at end of the study. (e.g. participants screened for study eligibility and enrollment were documented. Also, reasons for non-participation and completion of the study were recorded). Compliance using components of the RADAR-base system.
Acceptability of remote monitoring system in patients with lung disease.
Time frame: 6 months
TAM-FF: Measure the impact of the technology being used and evaluate its acceptability, usability and performance.
Quantification of symptoms using various symptom questionnaires and scales.
Time frame: 6 months
1. Epworth Sleepiness Scale (Used to diagnose obstructive sleep apnea(OSA). 2. STOPBang Questionnaire (Used to diagnose obstructive sleep apnea(OSA).) 3. MRC Breathlessness (Dyspnoea scale that evaluates theimpact of breathlessness on daily activity) 4. St. George's Respiratory Questionnaire (SGRQ) 5. Pittsburgh Sleep Quality Index (PSQI) Sleep scoring questionnaire 6. Visual Analogue Scale (VAS) Cough
Report longitudinal mental health symptoms measures as reported by GAD7 and PHQ8 associated with the three diseases.
Time frame: 6 months
Impact of disease on mood and wellbeing and quality of life using generalised anxiety disorder assessment (GAD-7) from 0 to 21, and depression scale of the Patient Health Questionnaire (PHQ8), weekly for 6 months.
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
Time frame: 6 months
1. Fatigue Severity Scale (FSS) is A 9-item questionnaire used to measure fatigue in people with chronic diseases. 2. Garmin Body Battery value from the wearable (Garmin, Vivoactive 4). It uses activity, heart rate, and stress to estimate participant energy.
The assessment of novel phone based tests (Audio, Breathing Tests see: non-questionnaire Active App tests) for remote monitoring of respiratory health.
Time frame: 6 months
The ubiquity of smartphones presents an opportunity to use the phone itself as a health measuring tool for both applications. Active audio tasks such as pronouncing sustained vowels or counting from 1 to 20 will provide additional information on voice production dynamics that might be affected by lung disorder symptoms.Voice production tasks via the phone. These tasks will assess change in the phonatory respiratory system
2 secondary outcomes
Number of participants that experience one exacerbation within the stopping criteria for each group
Time frame: 6 months
Establish whether subclinical exacerbations can be identified in patients with lung fibrosis, and if exacerbations can be detected earlier with home monitoring.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Results publication: PubMed 34319235Ranjan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amos Folarin study director
King's College London
John Hurst principal investigator
University College, London
Joanna Porter principal investigator
University College, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of remote monitoring of patient symptoms and physiology using commercially available wearable sensors and questionnaires in patients with lung disease. (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05630599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.