Clinical trial NCT05218525: Testing a Prediction Algorithm Into a Running Telehealth System for Patients With COPD
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
COPD Exacerbation
COPD Exacerbation Acute
COPD
Keywords: chronic obstructive pulmonary disease
Denmark
acute episodes
machine learning
telehealth
telemonitoring
RCT
decision support systems
predictive analytics
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, parallel two-armed randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Exacerbations
timeFrame: 6 months follow-up
Secondary outcomes:
measure: To compare the change in health-related quality of life (SF-12v2) at the individual level from baseline to follow-up at 6 months.
timeFrame: 6 months follow-up
measure: To compare the change in health-related quality of life (EQ5D-5L) at the individual level from baseline to follow-up at 6 months.
timeFrame: 6 months follow-up
measure: 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
timeFrame: 6 months follow-up
Other outcomes:
measure: Health literacy level
timeFrame: Baseline
measure: Estimation of the specialized COPD community nurse's level of participant's health literacy
timeFrame: Through study completion, an average of six months
measure: Evaluation of the specialized COPD community nurses' experiences with the usability of the COPD prediction algorithm
timeFrame: 6 months follow-up
measure: Evaluation of the participants experiences' with the usability of the telehealth system
timeFrame: 6 months follow-up
measure: Evaluation of the participants' experience with data ethical aspects
timeFrame: 6 months follow-up
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Aalborg University
name: Stine Hangaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kronborg T, Mark L, Cichosz SL, Secher PH, Hejlesen O. Population exacerbation incidence contains predictive information of acute exacerbations in patients with chronic obstructive pulmonary disease in telecare. Int J Med Inform. 2018 Mar;111:72-76. doi: 10.1016/j.ijmedinf.2017.12.026. Epub 2017 Dec 29.
citation: Udsen FW, Lilholt PH, Hejlesen O, Ehlers LH. Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial. Trials. 2014 May 21;15:178. doi: 10.1186/1745-6215-15-178.
citation: Lilholt PH, Witt Udsen F, Ehlers L, Hejlesen OK. Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish 'TeleCare North' cluster-randomised trial. BMJ Open. 2017 May 9;7(5):e014587. doi: 10.1136/bmjopen-2016-014587.
citation: Lilholt PH, Haesum LK, Hejlesen OK. Exploring User Experience of a Telehealth System for the Danish TeleCare North Trial. Stud Health Technol Inform. 2015;210:301-5.
citation: Witt Udsen F, Lilholt PH, Hejlesen O, Ehlers L. Cost-effectiveness of telehealthcare to patients with chronic obstructive pulmonary disease: results from the Danish 'TeleCare North' cluster-randomised trial. BMJ Open. 2017 May 17;7(5):e014616. doi: 10.1136/bmjopen-2016-014616.
citation: Secher PH, Hangaard S, Kronborg T, Haesum LKE, Udsen FW, Hejlesen O, Bender C. Clinical implementation of an algorithm for predicting exacerbations in patients with COPD in telemonitoring: a study protocol for a single-blinded randomized controlled trial. Trials. 2022 Apr 26;23(1):356. doi: 10.1186/s13063-022-06292-y.