Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240353
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : February 3, 2021
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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.


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: COPD digital support service

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remote-management of COPD: Evaluating Implementation of Digital Innovations to Enable Routine Care
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
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
Use of COPD digital services to record patient symptoms, integrate physiology monitoring, communicate with the clinical team and track interaction
Other Name: Lenus Health COPD




Primary Outcome Measures :
  1. Patient utilisation of digital service [ Time Frame: 24 months (12 months recruiting) ]
    Proportion of enrolled high-risk COPD patients successfully utilising remote-management in a digital service model


Secondary Outcome Measures :
  1. Clinical outcomes [ Time Frame: 24 months (12 months recruiting) ]
    Impact of digitally-enabled remote management on clinical outcomes including COPD exacerbations, unscheduled care contact, hospitalisation and occupied bed days, compared to historical and contemporary SafeHaven cohort (electronic health care record dataset) cohorts

  2. Clinical service outcomes [ Time Frame: 24 months (12 months recruiting) ]
    Impact of digital service model on clinical service outcomes including number, nature and complexity of reviews for remotely managed NIV and supported self management.

  3. Machine-learning analyses [ Time Frame: 24 months (12 months recruiting) ]
    Machine-learning supported exploratory analyses of associations and relative predictive importance of electronic health record, patient-reported outcomes, wearables physiology and NIV parameters

  4. Patient-centred outcomes [ Time Frame: 24 months (12 months recruiting) ]
    Impact of digital service on patient-centred outcomes including health related quality of life (EQ5-D) at baseline and monthly during study and qualitative user research with semi-structured user experience interviews.

  5. Healthcare cost analyses of digital service model [ Time Frame: 24 months (12 months recruiting) ]
    Assessment of healthcare costs associated with the digital service model including development and installation costs, recurring costs, and projected direct/indirect costs savings compared to previous service model



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240353


Locations
Layout table for location information
United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom, G51 4TF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
Layout table for investigator information
Principal Investigator: Chris Carlin NHS Greater Glasgow and Clyde
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04240353    
Other Study ID Numbers: INGN18RM173
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases