Self management and support programme (EDGE) for COPD
| ISRCTN | ISRCTN40367841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40367841 |
| Protocol serial number | 13281 |
| Sponsor | Oxford University (UK) |
| Funder | Wellcome Trust (UK) |
- 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
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional process of care study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
St George's Respiratory Questionnaire for COPD patients (SGRQ-C) measured at baseline, six months and twelve months |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University of Oxford
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/03/2017 | Yes | No | |
| Results article | results | 03/05/2017 | Yes | No | |
| Protocol article | protocol | 08/01/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/05/2017: Publication reference added.
09/03/2017: Publication reference added.
