NCT05218525

Testing a Prediction Algorithm Into a Running Telehealth System for Patients With COPD

Can a Predictive Algorithm Used to Flag Risk of Exacerbations in a Telehealth System Strengthen the Effectiveness and Cost-effectiveness Outcomes When Monitoring Patients With COPD?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Aalborg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will test a COPD prediction algorithm into a telehealth system from the previous Danish large-scale trial, TeleCare North (NCT01984840). The COPD prediction algorithm aims to support clinical decisions by predicting exacerbations in patients with COPD based on selected physiological parameters (blood pressure, oxygen saturation, and pulse). A prospective, parallel two-armed randomized controlled trial with approximately 200 COPD participants will be conducted.

Detailed description

Several studies call for research investigating telehealth' ability to predict exacerbations. Use of clinical prediction tools might be promising to improve telehealth services related to prediction of exacerbations and to support decision-making. However, more research is needed to further develop, test, and validate prediction algorithms to ensure that these algorithms improve clinical outcomes before they are widely implemented in practice. This trial seeks to demonstrate that through telehealth, the implementation of a COPD prediction algorithm might have potential to support early detection of exacerbations. The COPD prediction algorithm might initiate timely treatment, which can potentially led to improvement in COPD patients' health and fewer hospitalizations. The primary outcome is the number of exacerbations defined as an all-cause acute hospitalization from baseline to follow-up in both groups. The trial hypothesizes that integrating a COPD prediction algorithm into the telehealth system will lead to a significantly lower number of exacerbations through early identification and timely preventive treatment. The primary outcome will be statistically analyzed, and the hypothesis will be tested between groups. All participants are familiar with the telehealth system in advance. In addition to the participants' usual monitored measurements, they are asked to measure their oxygen saturation twice a week during the trial period. The participants will receive the questionnaires; EuroQol-5D-5L, Short-Form 12 item, version 2 Health Survey, The European Health Literacy Survey Questionnaire, The Danish Test of Functional Health Literacy in Adults, Danish Telehealth Usability Questionnaire, and a questionnaire containing selected demographic characteristics at baseline and at 6-month follow-up.

Conditions

• Chronic Obstructive Pulmonary Disease
• COPD Exacerbation
• COPD Exacerbation Acute
• COPD

Interventions

Type	Name	Description
OTHER	Algorithm	Participants in the intervention group will receive the general offer of the telehealth intervention including the telehealth system with the implemented COPD prediction algorithm. The participants are asked to measure their vital signs and respond to COPD related questions as usual. "As usual" refers to fixed days in the week, either Monday or Thursday, where the participants must measure their vital signs. In addition, the participants must weekly measure two oxygen saturation measurements drawn from the fingertip pulse oximeter.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-02-01
• Last updated: 2023-08-15

Locations

1 site across 1 country: Denmark