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

NCT04240353 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2021-02-03

No results posted yet for this study

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

Interventions

OTHER

COPD digital support service

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

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Chris Carlin · NHS Greater Glasgow and Clyde

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240353 on ClinicalTrials.gov