Real-world Evidence Feasibility Trial, in Both Community and Hospital-based Settings, for a Technology-enabled Hybrid Service Delivery Model for Pulmonary Rehabilitation: Assessing Patient Uptake and Adherence, and Impact on Patient Outcomes and Service Capacity.

Pulmonary rehabilitation (PR) for patients with respiratory disease, e.g. chronic obstructive pulmonary disease (COPD) and bronchiectasis, improves exercise capacity, quality-of-life and provides vital education for condition management. PR is now recommended for all COPD patients (NICE guidelines NG115).

A standard PR programme involves two, in-person, exercise classes per week over a period of 8 weeks after which the patient is discharged to self-care. While retaining some in-person contact, technology could increase access and automate delivery of education and exercise by overcoming shortages of skilled staff. New technology exists to allow the delivery of a hybrid PR programme which may be used to support a move to a remotely delivered service (with patients having the opportunity to attend in-person PR sessions during the programme if they need the motivation or support of an in-person session).

This study will use the UKCA/CE Class I-approved and DTAC-certified Active+me REMOTE App (Aseptika Ltd www.activ8rlives.com). The Active+me App, accessible by patients on their smartphones with Bluetooth or connected medical monitors, includes remote tracking of adherence, symptoms and physiological parameters (where appropriate); live, online video exercise classes; pre-recorded classes; a paced walking programme; an educational programme delivered in bite-sized pieces; and personalised care plans for every patient.

Generally, NICE guidance draws on randomised controlled trials (RCTs) to inform guidelines however RCTs are costly and time consuming for digital healthcare and this delays uptake and adoption by the NHS. New and innovative approaches to obtaining effectiveness evidence for digitally delivered healthcare are urgently needed and new approaches and solutions are being reviewed by NICE. This feasibility study will use a real-world study design drawing on routinely collected data to compare outcomes for patients recruited to a Hybrid PR Intervention with a propensity-matched Control Group that has previously received Standard PR. Additional data will be collected from the Hybrid PR group (via Active+me REMOTE / Trial Surveys) to provide supporting evidence relating to uptake, adherence, clinical outcomes (not routinely recorded in standard practice), and usability/acceptability of the Hybrid PR programme.

Patients with chronic respiratory disease who are referred to the Harefield Pulmonary Rehabilitation Programme will be screened for eligibility to participate in the Hybrid PR Trial. Informed consent will obtained in eligible patients who wish to take part. Recruited participants will follow a hybrid PR programme (Intervention Group). The Control Group will be patients that have previously received a standard pulmonary rehabilitation programme and are matched on specified criteria including age, sex, measure of respiratory disability, index of multiple deprivation, exercise capacity and hospital vs community location.