Contact information
Type
Scientific
Primary contact
Dr Christy Toms
ORCID ID
Contact details
University of Oxford
Department of Primary Health Care
Institute of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
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christy.toms@dphpc.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13281
Study information
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
Acronym
Study hypothesis
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
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
Study design
Randomised interventional process of care study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic obstructive pulmonary disease.
Intervention
An mHealth system to monitor health and provide additional educational support compared to usual care
Intervention type
Other
Phase
Not Applicable
Drug names
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 trial start date
05/11/2012
Overall trial end date
30/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 295
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
05/11/2012
Recruitment end date
30/01/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Oxford
OX3 7LF
United Kingdom
Sponsor information
Organisation
Oxford University (UK)
Sponsor details
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Wellcome Trust (UK)
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/24401729
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28270380
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28468749
Publication citations
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Protocol
Farmer A, Toms C, Hardinge M, Williams V, Rutter H, Tarassenko L, Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial., BMJ Open, 2014, 4, 1, e004437, doi: 10.1136/bmjopen-2013-004437.