Self management and support programme (EDGE) for COPD

ISRCTN	ISRCTN40367841
DOI	https://doi.org/10.1186/ISRCTN40367841
Secondary identifying numbers	13281

Submission date: 17/10/2012
Registration date: 17/10/2012
Last edited: 05/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christy Toms
Scientific

University of Oxford
Department of Primary Health Care
Institute of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom

Email	christy.toms@dphpc.ox.ac.uk

Study information

Study design	Randomised interventional process of care study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	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
Study objectives	Chronic obstructive pulmonary disease (COPD) is a chronic respiratory condition that affects 210 million people globally and an estimated 3 million people in the UK alone. COPD is a progressive disease without cure and it is estimated that COPD will become the third leading cause of death worldwide by 2020. The potential of mHealth technology in providing updates on patient status without the need for home visiting may offer opportunities for providing greater support than currently available for COPD patients. The mHealth system incorporates support for all aspects of care currently provided through personalised treatment plans, educational material in the form of videos and access to medical and medication records, to increase the impact of measures to improve care already in place. The system also includes a monitoring module allowing oxygen saturation measurement and a symptom diary with trend analysis to allow both patients and clinicians to identify deterioration. The sElf management anD support proGrammE (EDGE) for COPD is a clinical trial to evaluate the efficacy of an mHealth application used with a community respiratory nurse service to support patients with moderate to severe COPD in improving quality of life in comparison with usual care. There will be a pilot phase to refine the intervention and measures in preparation for the main trial.
Ethics approval(s)	South Central - Berkshire research ethics committee, ref: 12/SC/0437 Added 21/11/2013: ethical approval granted for amended criteria by South Central - Berkshire research ethics committee on 09/05/2013
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease.
Intervention	An mHealth system to monitor health and provide additional educational support compared to usual care
Intervention type	Other
Primary outcome measure	St George's Respiratory Questionnaire for COPD patients (SGRQ-C) measured at baseline, six months and twelve months
Secondary outcome measures	No secondary outcome measures
Overall study start date	05/11/2012
Completion date	30/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	UK Sample Size: 295
Key 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 <80% AND predicted ratio of FEV1 to forced vital capacity (FVC) <0.70 OR clinical decision of suitability for patients who are unable to provide a spirometry reading (on clinical grounds) at full assessment. The patient must have prior clinical evidence of COPD, i.e. obstructive spirometry within the last ten years; radiological evidence of emphysema. 3. Smoking history > 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 <70% 3. Predicted ratio of FEV1 to forced vital capacity (FVC) <0.70 4. Smoking history > 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	05/11/2012
Date of final enrolment	30/01/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Oxford

Oxford
OX3 7LF
United Kingdom

Sponsor information

Oxford University (UK)
University/education

Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
England
United Kingdom

Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Research organisation

Wellcome Trust (UK)
Private sector organisation / International organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	08/01/2014	Yes	No
Results article	results	07/03/2017	Yes	No
Results article	results	03/05/2017	Yes	No

Editorial Notes

05/05/2017: Publication reference added.
09/03/2017: Publication reference added.