RECEIVER: Digital Service Model for Chronic Obstructive Pulmonary Disease (COPD)

NCT04240353 | Unknown

• 1 other identifier: INGN18RM173
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a serious but treatable chronic health condition. Optimised management improves symptoms, complications, quality of life and survival. Disease exacerbations, which have adverse outcomes and often trigger hospital admissions, underpin the rising costs of managing COPD (projected increase in the United Kingdom (UK) to £2.3bn by 2030). The costs and care-quality gap of COPD exacerbations, coupled with the global rising prevalence present a major healthcare challenge. This study proposal, which has been developed in partnership with patients, clinicians, enterprise and government representation is to conduct an implementation and effectiveness observational cohort study to establish a continuous and preventative digital health service model for COPD. The implementation proposals comprise: -

• Establishing a digital resource for high-risk COPD patients which contains symptom diaries (structured patient reported outcome questionnaires), integrates physiology monitoring (FitBit and home NIV therapy data), enables asynchronous communication with clinical team, supports COPD self-management and tracks interaction with the service (for endpoint analyses).
• Establishing a cloud-based clinical COPD dashboard which will integrate background electronic health record data, core COPD clinical dataset, patient-reported outcomes, physiology and therapy data and patient messaging to provide clinical decision support and practice-efficiencies, enhancing delivery of guideline-based COPD care.
• Use the acquired dataset to explore feasibility and accuracy of machine-learned predictive modelling risk scores, via cloud-based infrastructure, which will be for future prospective clinical trial. Our primary endpoint for the effectiveness evaluation is number of patients screened and recruited who successfully utilise and engage with this RECEIVER clinical service. The implementation components of the project will be iterated during the study, based on patient and clinical user experience and engagement. Secondary endpoints include a number of specified clinical outcomes, clinical service outcomes, machine-learning supported exploratory analyses, patient-centred outcomes and healthcare cost analyses.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Patient utilisation of digital service

  Proportion of enrolled high-risk COPD patients successfully utilising remote-management in a digital service model

  24 months (12 months recruiting)

Secondary Outcomes (5)

• Clinical outcomes

  24 months (12 months recruiting)

• Clinical service outcomes

  24 months (12 months recruiting)

• Machine-learning analyses

  24 months (12 months recruiting)

• Patient-centred outcomes

  24 months (12 months recruiting)

• Healthcare cost analyses of digital service model

  24 months (12 months recruiting)

Study Arms (1)

COPD group

Patients with high-risk COPD with recent exacerbation requiring hospitalisation (within last 12 months) or hypercapnia respiratory failure and/or sleep disordered breathing meeting criteria for provision of home NIV.

Other: COPD digital support service

Interventions

COPD digital support service OTHER

Use of COPD digital services to record patient symptoms, integrate physiology monitoring, communicate with the clinical team and track interaction

Also known as: Lenus Health COPD

COPD group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with high risk COPD presenting to secondary care with COPD exacerbation or persisting hypercapnic respiratory failure (requiring home NIV)

You may qualify if:

• confirmed diagnosis of chronic obstructive pulmonary disease, established pre-screening or at screening, defined as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 guidelines
• home non-invasive ventilation cohort: hypercapnic respiratory failure and/or sleep-disordered breathing meeting established criteria for provision of home NIV
• exacerbation cohort: recent presentation to secondary care with exacerbation of COPD, defined as per GOLD 2019 guidelines
• patient or close-contact has access to smartphone, tablet or daily home computer web-browser
• informed consent
• ≥18 years of age

You may not qualify if:

• inability to comprehend informed consent
• communication barrier precluding use of COPD digital service

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Related Publications (1)

• Taylor A, Lowe DJ, McDowell G, Lua S, Burns S, McGinness P, Carlin CM. Remote-Management of COPD: Evaluating the Implementation of Digital Innovation to Enable Routine Care (RECEIVER): the protocol for a feasibility and service adoption observational cohort study. BMJ Open Respir Res. 2021 Aug;8(1):e000905. doi: 10.1136/bmjresp-2021-000905.

  PMID: 34462271 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Carlin

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: August 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)