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Self management and support programme (EDGE) for COPD

A pilot study and randomised trial of a multicomponent mobile-health based intervention compared with usual care to improve outcomes in chronic obstructive pulmonary disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40367841
Enrollment
295
Registered
2012-10-17
Start date
2012-11-05
Completion date
Unknown
Last updated
2017-06-05

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

Conditions

Chronic obstructive pulmonary disease. Respiratory Chronic obstructive pulmonary disease, unspecified

Interventions

An mHealth system to monitor health and provide additional educational support compared to usual care

Sponsors

Oxford University (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 21/11/2013: 1. Aged > 40 years 2. A forced expiratory volume in 1 second (FEV1) post-bronchodilatory 10 pack years 4. MRC Dyspnoea scale >or = to 2 5. Registered with a general practice and with an exacerbation of COPD requiring hospital admission or home treatment in the previous year, or referred for pulmonary rehabilitation 6. Absence of other significant lung disease 7. Absence of chronic heart failure defined by the New York Heart Association classification system as severe (Grade IV) 8. Able to give informed consent 9. Able to complete questionnaires and use the mHealth system 10. Life expectancy of >3 months 11. No recent participation in a COPD self-management clinical trial programme 12. Patients unable to transmit data from the tablet due to insufficient internet access will not be eligible to enter the study Previous inclusion criteria: 1. Aged > 40 years 2. Forced expiratory volume in 1s (FEV1) post-bronchodilatory 10 pack years 5. MRC Dyspnoea scale >or = to 2 6. Registered with a general practice and with an exacerbation of COPD requiring hospital admission or home treatment in the previous year, or referred for pulmonary rehabilitation 7. Absence of other significant lung disease 8. Absence of chronic heart failure 9. Able to give informed consent 10. Able to complete questionnaires and use the mHealth system 11. Life expectancy of >3 months 12. No recent participation in a COPD self-management clinical trial programme

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
St George's Respiratory Questionnaire for COPD patients (SGRQ-C) measured at baseline, six months and twelve months

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026