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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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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

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Chronic Obstructive Pulmonary Disease COPD Exacerbation COPD Exacerbation Acute COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, parallel two-armed randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The study is single-blinded, in which the participants do not know the treatment group that they have been assigned, i.e. the participants do not know if the COPD prediction algorithm runs in the background of their profile or not. The specialized COPD community nurses cannot be blinded, as they need to be trained in the use of the COPD prediction algorithm.

Study Groups

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Intervention group

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).

Group Type EXPERIMENTAL

Algorithm

Intervention Type OTHER

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER