Condition category
Respiratory
Date applied
17/10/2012
Date assigned
17/10/2012
Last edited
10/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13281

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 below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease.

Intervention

mHealth system, 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 measures

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

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

http://www.ox.ac.uk/

Funders

Funder type

Research organisation

Funder name

Wellcome Trust (UK)

Alternative name(s)

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24401729

Publication citations

  1. 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.

Additional files

Editorial Notes