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

Covid19 Clinical Trial

— RALPMH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05630599
• Other study ID #: 274070
• Status: Active, not recruiting
• Start date: July 26, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2022
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. heart rate, oxygen saturation, respiratory rate), including pulse oximeters, spirometer, mobile phones, digital tests, and smart phone symptom questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Covid19
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London
United Kingdom	University College London Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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):e28 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Provide data for power calculations for a follow on study.	Power calculations will be centered around understanding the number of exacerbations according to sample size and duration	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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	6 months
Secondary	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).	6 months
Secondary	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	6 months