Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Three studies are summarised in this briefing, including 2 randomised controlled trials and 1 observational study. In total, there were 167 people with chronic obstructive pulmonary disease (COPD) in these studies.

The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

Overall, the quantity and quality of comparative evidence for myCOPD is limited. None of the studies followed up participants for longer than 3 months, so there is no medium- or long-term evidence. All studies were relatively small (fewer than 100 people), and had limited power to detect statistical differences between treatment groups.

Bourne et al. (2018)

Study size, design and location

A feasibility randomised controlled trial of 41 people with COPD in the UK. People were recruited following a hospital admission for an acute exacerbation.

Intervention and comparator

myCOPD, compared with usual care (written self-management plan).

Key outcomes

In the study, people using myCOPD (n=22) had significantly fewer hospital admissions compared with people receiving usual care (n=21) during the 3-month follow up.

Inhaler technique (total critical error count) improved in the myCOPD group (101 errors at baseline, 20 errors at end of follow up) compared with usual care (100 to 72; p=0.008).

People in the myCOPD group had a significantly larger reduction in COPD assessment test (CAT) scores than people in the usual care group (p=0.021).

No differences were seen in the quality of life between treatment groups.

Strengths and limitations

The study was done in a single centre. The sample size was small. All people were followed up for 3 months in the study.

Bourne et al. (2017)

Intervention and comparator

A 6-week online pulmonary rehabilitation programme using myCOPD, compared with face-to-face pulmonary rehabilitation in a local rehabilitation facility.

Key outcomes

The myCOPD group (n=64) had a significantly larger reduction in mean CAT score from baseline to week 7, compared with the 'face-to-face' pulmonary rehabilitation group (n=26).

There was no significant difference in the 6‑minute walking test between the 2 groups.

There was a decline in attendance in the myCOPD group, from a mean of 3.9 sessions per person in week 1 to 2.5 sessions per person in week 6. The attendance at the face-to-face sessions was relatively stable, with a mean of 1.6 sessions per person in week 1 and 1.4 sessions per person in week 6.

The differences in the mean improvement in scores for the quality of life questionnaires were in favour of myCOPD, but were not statistically significant.

Strengths and limitations

The study was done in a single centre. The study had a short follow up (6 weeks). No safety issues were identified.

North (2015)

Intervention and comparator

myCOPD, compared with usual care (a written self-management plan).

Key outcomes

After the 3-month follow up, 21 of the 22 people who used myCOPD showed a significant decrease in their CAT score of 4 (SD=2.8) from the baseline. Five people in the usual care group showed an increase in mean CAT score of 2.4 (standard deviation=1.0) from the baseline. The difference between 2 groups was not reported.

The study suggested that 98% people using myCOPD were using their inhalers correctly at the end of the study. Those who only had access to written self management did not show an improvement in their inhaler technique and continued to have critical errors in using their devices.

Strengths and limitations

All people were followed up for 3 months in the study. The sample size was small. The study was reported as a brief article with limited details of the study methods.

Sustainability

Two experts said that people could use the technology in their own homes, so they do not need to travel to service centres.

Recent and ongoing studies

EARLY: A randomised controlled trial to explore how myCOPD can help people with mild, moderate COPD self-manage their condition. ClinicalTrials.gov identifier: NCT03620630. Status: recruitment completed. No interim results published. Indication: chronic obstructive pulmonary disease. Devices: myCOPD. Last update on 28 February 2020. UK.