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

Chronic Obstructive Pulmonary Disease Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05218525
• Other study ID #: 2020-068-01060
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: August 2023
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• COPD Exacerbation
• COPD Exacerbation Acute
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health literacy level	To assess the participants' health literacy level at baseline using the HLS-EU-Q16, supported by further assessment with the Danish TOFHLA during the trial period to examine whether the effect of the COPD prediction algorithm is similar in patients with COPD, regardless of health literacy level	Baseline
Other	Estimation of the specialized COPD community nurse's level of participant's health literacy	To examine whether the specialized COPD community nurse's estimate of the individual participant's level of health literacy influences the effect of the COPD prediction algorithm	Through study completion, an average of six months
Other	Evaluation of the specialized COPD community nurses' experiences with the usability of the COPD prediction algorithm	To evaluate the specialized COPD community nurses' experiences with the usability of the COPD prediction algorithm using interviews	6 months follow-up
Other	Evaluation of the participants experiences' with the usability of the telehealth system	To evaluate the participants' experiences with the usability of the telehealth system after trial completion using the questionnaire D-TUQ	6 months follow-up
Other	Evaluation of the participants' experience with data ethical aspects	To evaluate the participants' experiences with data ethical aspects after trial completion using qualitative research interviews	6 months follow-up
Primary	Exacerbations	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	6 months follow-up
Secondary	To compare the change in health-related quality of life (SF-12v2) at the individual level from baseline to follow-up at 6 months.	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	6 months follow-up
Secondary	To compare the change in health-related quality of life (EQ5D-5L) at the individual level from baseline to follow-up at 6 months.	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	6 months follow-up
Secondary	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	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	6 months follow-up