Feasibility study Of Remote Exacerbation Sensing & prEdiction in chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease (COPD)
Data collection methods: Component 1: User needs and formative HF/UE activities Intended users, use environments and context of use (use specification) The formative HF/UE work will define and document the intended context of use, including: Intended users: people with COPD and, where relevant, clinicians involved in COPD care (e.g. respiratory physicians, specialist nurses, physiotherapists). Clinician involvement at this stage focuses on understanding implementation considerations and does not involve use of the system for patient management. Use environment: predominantly home/remote settings (including periods of illness and fatigue), with variable connectivity, competing demands, and differing levels of digital literacy and health literacy. Operational context and training assumptions: onboarding and ongoing use with minimal training typical of remote monitoring deployments; any training materials or support processes used in the study will be documented as part of the “user interface” (including accompanying information). Conducting formative HF/UE work will enable us to identify and mitigate use-related risks. This will allow us to develop FORESEE safely, effectively and ensure it is fit for its intended users and clinical context. This formative work will be essential for future regulation of the platform as a medical device, as it will directly enable robust summative usability validation and provide the HF/UE evidence required to demonstrate compliance with IEC 62366-1 during regulatory assessment. Participants and recruitment: People with COPD will be recruited from respiratory services at two NHS sites (e.g. Bristol and Hull, including Hull Virtual Ward). Clinicians involved in COPD care will be invited via departmental networks. Data collection: 1. User-needs survey (approximately 60 people with COPD) Topics: current self-management practices; experience with digital/monitoring tools; preferences for monitoring frequency and format; acceptable burden;
1. Age: ≥18 years. 2. Diagnosis: Clinician-confirmed COPD, defined according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria. 3. Exacerbation history: Between 1 and 3 COPD exacerbations in the past 12 months requiring treatment with antibiotics, systemic corticosteroids and/or hospitalisation. 4. Consent: Able to provide written informed consent after full explanation of the study. Proxy consent is not permitted. 5. Digital participation: Willing and able, either independently or with support from a carer/family member, to: 5.1. Enter symptom data via a web or app-based platform 5.2. Wear a smartwatch for prolonged periods 5.3. Host and tolerate an in-home environmental monitoring device 6. Access to technology: Access to a compatible smartphone, tablet or computer (own or carer’s) and home internet/4G connection sufficient to support data transfer
1. Consent capacity: Significant cognitive impairment or other condition judged by the investigator to preclude informed consent. 2. Confounding respiratory diagnoses: A primary diagnosis of another chronic respiratory disease such as asthma, idiopathic pulmonary fibrosis, non-COPD bronchiectasis or other interstitial lung disease where COPD is not the predominant condition. 3. Significant comorbidities or instability: 3.1. Major cardiovascular event (e.g. myocardial infarction, stroke) within the past 3 months; 3.2. Unstable or decompensated cardiac, renal or hepatic disease where participation is considered unsafe by the investigator; 3.3. Active malignancy requiring systemic treatment (excluding localised non-melanoma skin cancer); or 3.4. Any other serious medical or psychiatric condition that, in the opinion of the investigator, would significantly interfere with participation or completion of the study. 4. Digital/device-related barriers: 4.1. Persistent inability or unwillingness to use the required digital devices despite training and support; 4.2. Known allergy or significant skin intolerance to materials used in the smartwatch strap or casing. 5. Other practical barriers: 5.1. Severe psychiatric or neurological conditions likely to impair protocol adherence; 5.2. Markedly unstable housing or lifestyle circumstances (e.g. no fixed abode) that would make device use or follow-up impracticable over 12 months.