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

Aalborg University

Status: Completed

Conditions: COPD Exacerbation Acute; Chronic Obstructive Pulmonary Disease; COPD; COPD Exacerbation

Treatments: Other: Algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT05218525

2020-068-01060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The trial population consists of patients with COPD who already use the telehealth system.

Inclusion criteria:

• Men and women >18 years
• Diagnosis of COPD
• Fixed residence in Aalborg Municipality.

Exclusion criteria:

• Unable to monitor vital signs
• Unable to complete study questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

Intervention group

Experimental group

Description:

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).

Treatment:

Other: Algorithm

Control group

No Intervention group

Description:

The specialized COPD community nurses responsible for patients in the control group will only experience the usual alarms that are activated in the telehealth system, named Telekit, and are based on low or high values of vital signs. The specialized COPD community nurses are not instructed to act differently compared to how they act normally. This involves that the specialized COPD community nurses monitor as usual and respond to divergent data as usual. The participants in the control group receive the usual practice, which includes the general offer of the telehealth intervention. The participants in the control group are instructed to do exactly the same procedures as the participants in the intervention group. The specialized COPD community nurses, who are responsible for patients in the control group continue to monitor the participants as usual, but are informed that more oxygen saturation measurements will be present for the included participants.