2. The authors have no competing interests to declare.

3. Self-management support using an Internet-linked tablet computer based intervention in chronic obstructive pulmonary disease: results of a randomised controlled trial.
Andrew J Farmer, Veronika Williams, Carmelo Velardo, Syed Ahmar Shah, Ly-Mee Yu, Heather Rutter, Louise Jones, Carl Heneghan, Jonathan Price, Maxine Hardinge, Lionel Tarassenko.

4. Aim – to test impact on quality of life in comparison with usual care
Important data source – prediction of exacerbations.
20 patients left to recruit, last patient end of June.

5. The EDGE intervention
Daily measurement of pulse, oxygen saturation and symptoms;
Charted displays of measured parameters for review
Review of personalised plans for self-management;
Brief video clips providing additional information about COPD and treatments (including medicines use and inhaler technique);
Educational advice on managing COPD, smoking cessation, diet, physical activity;
Monthly screening for depression and anxiety.
In the UK, the total annual estimated cost of COPD to the National Health Service (NHS) is over £800 million, with over half of this attributable to hospital-based care

6. Development of the EDGE platform

7. Design of the EDGE trial
Individually randomised controlled trial
An allocation ratio of 2:1 between intervention and standardised usual care
Inclusion criteria
Age >40 years
Predicted ratio of FEV1 to FVC <0.70
Smoking history >10 pack years
MRC dyspnoea scale >2
Admission for COPD or referred for pulmonary rehabilitation

8. EDGE trial profile Screened for eligibility n=206
Randomised n=166
Allocated to EDGE intervention n=110
Received allocated intervention†: n=105 (95.5%)
Did not receive allocated intervention n=5 (n=5 )
Allocated to standard care n=56
Received allocated intervention n=56 (100%)
Withdrawn n=14 (12.7%)
Died n=5
Too time consuming n=4
Patient ill n=2
Moved n=1
Patient saw no benefit n=1
Other n=1
Withdrawn n=7 (12.5%)
Died n=4
Too time consuming n=1
Other n=2
Primary outcome SGRQ-C at 12 months analysed
n=93 (84.5%)
n=48 (85.7%)
Excluded n=40 (19.4%)
Not eligible n=40*
MRC Dyspnoea score<2 n=3
Smoke history<10 pack years n=13
Insufficient information on lung function n=18
FEV1/FVC>=0.70 n=11
Mild COPD n=12
EDGE trial profile
* Not mutually exclusive
†Defined as using the intervention for at least 30 days, during which time it was used for at least 3 out of 7 days per week

9. Feasibility and usability
Of the 110 given the EDGE system 100 (91%) used it for at least six months.
On average, people used the system for six days each week.
Only two people used the system for less than three days a week.

10. EDGE Primary Outcome
COPD related quality of life (SGRQ-C) improves in patients allocated to both the EDGE system and to usual care from baseline to six months, and again to twelve months.
The estimated difference in SGRQ-C at twelve months (EDGE system - usual care) was -1.7 with a 95% confidence interval of -6.6 to 3.2 (p=0.49)

11. EDGE Secondary outcomes
The relative risk of hospital admission for EDGE was 0.83 (0.56 to 1.24, p=0.37) compared to usual care.
There was a significant difference in overall health status measured with the EQ-5D-5L between groups (0.008 to 0.14, p=0.025), with better health status for the digital health group.
The median number of visits (digital health system vs. usual care respectively were for general practitioners (4 vs. 5.5, p=0.062) and practice nurses (1.5 vs. 2.5, p=0.033).
The numbers of deaths did not differ between groups.
Numbers of exacerbations did not differ overall between groups.
People’s attitudes to medicines and their reported use of medicines were not different.
Depression measured with the SCL-20 and anxiety measured with the SCL-10A were not significantly different between groups.

12. EDGE secondary outcomes
Relative risk of hospital admission
Difference in change in EQ-5D 5L Score
Difference in relative risk of hospital admission
EQ-5D-5L score
0.083
Between group difference

13. Sub-group analysis by primary outcome

14. Costs associated with the intervention and outcomes
Practice Nurse
£14 per face to face contact (average duration 15 minutes) GP
£46 per face to face contact (average duration 11 minutes)
Hospital stay (non-elective short stay)
£611 per day
Equipment
Tablet computer: £319
Pulse oximeter probe: £399.

15. Summary
Mobile devices presenting charted data are used extensively by trial participants
No evidence that mobile devices have an impact on on COPD related quality of life
Impact on health status and impact on contacts with nursing staff provide support for a benefit
Potential for an important impact on use of hospital services
Qualitative work providing further insight into these findings will be presented in Abstract Session 14: eHealth & Self Management G by Veronika Williams.

16. Acknowledgments
We would like to thank all members of the EDGE COPD research team: Dr Louise Jones, Heather Rutter, Stephanie Robinson, Dr Maxine Hardinge, Dr Jonathan Price, Prof Carl Heneghan, Dr Carmelo Velardo, Dr Syed Shah, Dr Andreas Triantafyllidis, Dr Dario Salvi and the participants for giving us their time and sharing their experiences.
This study was part of a project funded by the Wellcome Trust and Department of Health, under the Health Innovation Challenge Fund award (HICF ). This publication presents independent research supported by the Health Innovation Challenge Fund, a parallel funding partnership between the Department of Health and Wellcome Trust.
The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health or Wellcome Trust.