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

NCT05218525 | Completed

• 1 other identifier: 2020-068-01060
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Other Outcomes (5)

• Health literacy level

  Baseline

• Estimation of the specialized COPD community nurse's level of participant's health literacy

  Through study completion, an average of six months

• Evaluation of the specialized COPD community nurses' experiences with the usability of the COPD prediction algorithm

  6 months follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Other: Algorithm

Control group

NO INTERVENTION

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.

Interventions

Algorithm 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, Denmark

Location

Related Publications (7)

• 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.

  PMID: 29425637 BACKGROUND

• 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.

  PMID: 24886225 BACKGROUND

• 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.

  PMID: 28490555 BACKGROUND

• 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.

  PMID: 25991154 BACKGROUND

• 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.

  PMID: 28515193 BACKGROUND

• Laursen SH, Haesum LKE, Egmose J, Kronborg T, Udsen FW, Hejlesen OK, Hangaard S. Implementation of an algorithm for predicting exacerbations in telemonitoring: A multimethod study of patients' and clinicians' experiences. Int J Nurs Stud Adv. 2024 Oct 22;7:100257. doi: 10.1016/j.ijnsa.2024.100257. eCollection 2024 Dec.

  PMID: 39555388 DERIVED

• 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.

  PMID: 35473589 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

• Stine Hangaard, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, parallel two-armed randomized controlled trial

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: February 1, 2022
• Study Start: October 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)