Chronic obstructive pulmonary disease (COPD) Respiratory
Conditions
Interventions
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 documen
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
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Previous primary outcome: 1. Participant engagement with the remote monitoring system measured using the proportion of days participants complete daily symptom reports and wear the wrist-worn device (percentage adherence over the monitoring period), at over 12 months following enrolment | — |
Countries
England, United Kingdom
Contacts
Public ContactHenry Glyde
Outcome results
None listed