Advice
Clinical and technical evidence
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
This briefing summarises 3 publications, including 278 adults. The publications reported results from the RECEIVER and DYNAMIC-SCOT studies. It is assumed that publications on the same studies included the same people.
All studies were observational cohort studies that were reported in 1 non-peer-reviewed pre-print and 2 abstracts. There are other abstracts not described here reporting interim results from the RECEIVER study (Taylor et al. 2021a, Taylor et al. 2020). The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.
Overall assessment of the evidence
Lenus COPD Support Service is a tier C digital health technology for active monitoring and self-management based on NICE's evidence standards framework for digital health technologies. The published evidence is limited to 1 non-peer-reviewed pre-print and 4 abstracts. The RECEIVER study meets the minimum evidence standard for this type of digital health technology. But it was affected by the COVID‑19 pandemic and was paused in March 2020. This study was later scaled-up to include people who had previous contact with secondary care chronic obstructive pulmonary disease (COPD) services (DYNAMIC-SCOT).
The evidence reported that people using Lenus COPD Support Service had improved patient-reported outcomes and reduced respiratory-related hospital admissions and occupied bed days. The studies show significantly lower take-up and use of the service compared with the number of people initially offered it. Some of this is attributed to lack of access to the required technologies. The evidence would be strengthened by peer-reviewed prospective studies comparing Lenus COPD Support Service with standard care.
Taylor et al. (2022)
Study size, design and location
Observational cohort studies in 225 adults with COPD in the UK who had daily access to a smartphone, tablet, or computer with internet. This non-peer-reviewed pre-print reports minimum 1-year results of the RECEIVER (n=83) and DYNAMIC-SCOT (implementation cycle 1, n=142) studies.
People enrolled in the DYNAMIC-SCOT trial had lower rates of smoking, home oxygen or non-invasive ventilation (NIV) therapy needs, pulmonary rehabilitation, and osteoporosis than people in the RECEIVER trial. But they had higher rates of bronchiectasis and ischaemic heart disease.
Comparator
A matched control cohort was used for analysis. Each person in the RECEIVER trial was matched with 5 people from the NHS Greater Glasgow and Clyde Safe Haven dataset.
Key outcomes
People in the RECEIVER and DYNAMIC-SCOT studies did an average of 3.5 and 3 daily patient reported outcome sets per week, respectively.
The intervention groups had significantly lower risk of respiratory-related hospital admission or death than the matched control cohort. The hazard ratio for admission or death was 0.47 (95% confidence interval [CI] 0.34 to 0.63, p<0.001) in the RECEIVER cohort and 0.39 (95% CI 0.26 to 0.59, p<0.001) in people in the DYNAMIC-SCOT group who had an admission in the year before enrolment. Results also reported lower 12-month all-cause mortality in the RECEIVER cohort (17%) and the DYNAMIC-SCOT group with admission in the year before enrolment (9%) than the control group (33%).
Median time to respiratory-related hospital admission or death was 338 days (interquartile range [IQR] 73.5 to 596) in the RECEIVER cohort, 400 days (IQR 161 to 450) in people in the DYNAMIC-SCOT group who had an admission in the year before enrolment, and 43 days (IQR 4 to 284) in the control cohort.
Occupied bed days were also reduced after enrolment to Lenus COPD Support Service in the RECEIVER study (median 9 compared with 0, effect size 0.53) and DYNAMIC-SCOT group with an admission in the previous year (median 8 compared with 0, effect size 0.44) compared with the matched control (median 9 compared with 3, effect size 0.26).
Strengths and limitations
This paper reports 1‑year data from the RECEIVER and DYNAMIC-SCOT studies. It used a matched control cohort from an NHS database. People needed daily access to a smartphone, tablet, or computer with internet to take part. The RECEIVER trial screened 283 people, with 83 having the intervention. The authors noted that 41 people were unable to take part in the study because they did not have access to the necessary technology. This may limit generalisability of findings to people with lower digital literacy and reduced access to technology.
People in the RECEIVER cohort used Lenus COPD Support Service more than the DYNAMIC-SCOT group. Authors suggested there may be different motivations that could affect use and noted the need for healthcare professional contact and supporting resources. They concluded that more analysis is needed on patient-perceived benefits, motivations, and barriers for use. The company was involved in the research.
Taylor et al. (2021b)
Intervention
Lenus COPD Support Service. In response to the COVID‑19 pandemic, people were sent a text message inviting them to the digital service and registration was done online.
Key outcomes
A total of 195 people applied to the digital service. Of these, 112 people completed the service setup, which included a virtual review with a healthcare professional, self-management planning, and COPD multidisciplinary team input as needed. Authors stated that app usage was positive. Qualitative data showed that more information about the service was needed at invitation.
Strengths and limitations
This study reports remote enrolment to Lenus COPD Support Service in response to the COVID‑19 pandemic. A total of 1,576 text message invites were sent between May and July 2020 to people who had any previous contact with secondary care COPD services. Of these, 7.1% completed setup to the service. The study was reported in abstract only and lacked details of study methods and findings. It stated that there was positive patient experience, but data on this was not provided. The company was involved in the research.
Taylor et al. (2021c)
Study size, design and location
Observational cohort study in 32 adults with high-risk COPD who used Fitbit continuously in the UK. This abstract reports 6‑month interim results of the RECEIVER trial.
Intervention
Lenus COPD Support Service with Fitbit Charge 3 device. Daily patient reported outcomes and exacerbation events were recorded along with daily step counts and daily average heart rate.
Key outcomes
There was a mean 58 days of data available (range 8 to 147). Authors reported that there were trends in daily step count and heart rate around exacerbation events. There was an increase in daily step counts and a decrease in heart rate after exacerbation events and after people started home NIV. Authors concluded that Fitbit data could be used to track and predict COPD events.
Strengths and limitations
This was an interim analysis reported in abstract. There were limited details of study methods and findings, with trends in data reported graphically. Although the study aimed to capture daily outcomes, data was recorded less often (mean 58 days). This suggests that people used the devices less than advised. The company was involved in the research.
Sustainability
The company claims the technology uses less energy and has a lower environmental impact than standard care. There is no published evidence to support these claims.
Recent and ongoing studies
RECEIVER: Digital service model for chronic obstructive pulmonary disease (COPD). This is a prospective observational cohort study evaluating a continuous and preventative digital health service model for COPD. ClinicalTrials.gov identifier: NCT04240353. Status: active, not recruiting. Indication: COPD. Device: Lenus COPD Support Service. Last updated: February 2021. Country: UK.