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Optimising the feasibility and acceptability of a multi-component, digital health intervention to improve outcomes for people with chronic obstructive pulmonary disease

sElf-management anD support proGrammE (EDGE2) for COPD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN82570166
Enrollment
100
Registered
2019-07-05
Start date
2019-05-13
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Respiratory Chronic Obstructive Pulmonary Disease (COPD)

Interventions

EDGE2 is a cohort study and all participants will access the intervention. The intervention will comprise an internet-linked tablet computer and two monitoring devices to support their self-management

Sponsors

Clinical Trials and Research Governance – University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Be willing and able to give informed consent 2. Be aged 40 years or older 3. Have a clinical diagnosis of chronic obstructive pulmonary disease recorded in their medical history 4. Be a current or ex-smoker 5. Be an acute hospital attendance/admission for an exacerbation of chronic obstructive pulmonary disease or pulmonary infection 6. Be able to complete questionnaires (electronic or paper) and use the tablet computer 7. Confirm their post-discharge destination is not a medical facility or prison 8. Lives in Oxfordshire or surrounding counties 9. Be able to adequately understand verbal and written English

Exclusion criteria

Exclusion criteria: 1. Another significant lung disease e.g. lung cancer 2. Chronic heart failure defined by the New York Heart Association classification system as severe (Grade IV) 3. Have a life expectancy of less than six months or be on a palliative pathway

Design outcomes

Primary

MeasureTime frame
1. Proportion of participants in whom data can be obtained and matched from the in-hospital system and the EDGE2 platform – extract and link in-hospital data with other study data for each patient, success pre-defined as 80-90% – initiation of linkage will take place upon provision of consent with in-hospital data retrieved from point of index attendance/admission to discharge. 2. Proportion where there is sufficient data to provide clinically relevant data for use across the care pathway – obtain and link in-hospital data with other study data for each patient, success pre-defined as 80-90% – initiation of linkage will take place upon provision of consent with in-hospital data retrieved from point of index attendance/admission to discharge.

Secondary

MeasureTime frame
1. Quality of life - using St George’s Respiratory Questionnaire for COPD (SGRQ-C) - at baseline and 6 months after hospital discharge 2. Generic health status - using the EuroQol-5 Dimension (EQ-5D-5L) scale - at baseline and 6 months after hospital discharge 3. Number of hospital admissions - at baseline and 6 months after hospital discharge 4. Number of ICU admissions - at baseline and 6 months after hospital discharge 5. Number of contacts with health professionals - at baseline and 6 months after hospital discharge 6. Use of medications - at baseline and 6 months after hospital discharge 7. Physical function – using the sit-to-stand test - at baseline, 4 weeks, 12 weeks and 24 weeks after hospital discharge 8. Death - using NHS Digital’s Data Access Request Service 9. Attendance and admissions to hospital – using NHS Digital’s Data Access Request Service

Countries

England, United Kingdom

Contacts

Public ContactBethany Lawson
bethany.lawson@phc.ox.ac.uk01865 289259

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026