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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; COPD Exacerbation; COPD Exacerbation Acute; COPD
• Interventions: Other: Algorithm

• Registration Number: NCT05218525
• Lead Sponsor: Aalborg University

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-14
• Study Start: 2021-10-01
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-13
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Algorithm	The specialized COPD community nurses, who are responsible for patients in the intervention group, will experience an extra alarm option in the telehealth system. The COPD prediction algorithm has been implemented by the Danish Company, OpenTeleHealth, into their commercially available telehealth system, Telekit, and thus, the COPD prediction algorithm is approved for clinical use as a part of the existing telehealth system´s CE marking (class I and IIa).

Primary Outcome Measures

Name	Time	Method
Exacerbations	6 months follow-up	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

Secondary Outcome Measures

Name	Time	Method
To compare the ICER (EQ-5D-5L) measured as the cost per quality adjusted life years (QALY) at the individual level from baseline to follow up at 6 months	6 months follow-up	The incremental cost-effectiveness ratio or ICER measured as the total cost per quality adjusted life years (QALY) gained for the cost-categories included in the study from baseline to follow up at six months. It is hypothesized that the cost of hospital contacts will decrease, but it is unknown whether this cost is offset by an increase in other cost-categories such as community care
To compare the change in health-related quality of life (SF-12v2) at the individual level from baseline to follow-up at 6 months.	6 months follow-up	The change in health-related quality of life (HRQoL) using SF-12v2 at the individual level from baseline to follow-up at 6 months. The trial hypothesizes that the difference in HRQoL from baseline to follow-up in both groups decrease since the participants have lived six months longer with COPD. However, it is expected that the decrease in HRQoL will be lower for the intervention group compared to the control group
To compare the change in health-related quality of life (EQ5D-5L) at the individual level from baseline to follow-up at 6 months.	6 months follow-up	The change in health-related quality of life (HRQoL) using EQ-5D-5L at the individual level from baseline to follow-up at 6 months. The trial hypothesizes that the difference in HRQoL from baseline to follow-up in both groups decrease since the participants have lived six months longer with COPD. However, it is expected that the decrease in HRQoL will be lower for the intervention group compared to the control group

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Denmark