Chronic Obstructive Pulmonary DiseaseNCT05218525
Testing a Prediction Algorithm Into a Running Telehealth System for Patients With COPD
A study testing Algorithm in people with Chronic Obstructive Pulmonary Disease and COPD Exacerbation, run by Aalborg University at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD Exacerbation, COPD Exacerbation Acute
- What is being tested?
- Algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women >18 years
- Diagnosis of COPD
- Fixed residence in Aalborg Municipality.
Who cannot join
- Unable to monitor vital signs
- Unable to complete study questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read the 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.
- Being tested
- Algorithm
- Keywords
- chronic obstructive pulmonary disease, Denmark, acute episodes, machine learning, telehealth, telemonitoring, RCT, decision support systems, predictive analytics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgorithmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: 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.
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
Measured: 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
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
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Oct 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, parallel two-armed randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole K. Hejlesen, Aalborg University
- Investigators
- Stine Hangaard, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218525
- Sponsor's protocol ID
- 2020-068-01060
- Status last verified
- Aug 2023
- First submitted
- 14 Sep 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29425637Udsen 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.
PubMed 24886225Lilholt 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.
PubMed 28490555Lilholt 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.
PubMed 25991154Witt 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.
PubMed 28515193Laursen 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.
PubMed 39555388Secher 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.
PubMed 35473589
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT05218525
- Acronym / sponsor ID
- 2020-068-01060
- Keywords
- chronic obstructive pulmonary disease, Denmark, acute episodes, machine learning, telehealth, telemonitoring, RCT, decision support systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, parallel two-armed randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: AlgorithmThe 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women >18 years
- Diagnosis of COPD
- Fixed residence in Aalborg Municipality.
Key exclusion criteria (2 listed)
- Unable to monitor vital signs
- Unable to complete study questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlgorithmParticipants 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. | Other | Intervention group |
Primary outcome
Exacerbations
Time frame: 6 months follow-up
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
3 secondary outcomes
To compare the change in health-related quality of life (SF-12v2) at the individual level from baseline to follow-up at 6 months.
Time frame: 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.
Time frame: 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
Time frame: 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 29425637Kronborg 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.
- Background: PubMed 24886225Udsen 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.
- Background: PubMed 28490555Lilholt 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.
- Background: PubMed 25991154Lilholt 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.
- Background: PubMed 28515193Witt 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.
- Derived from this study: PubMed 39555388Laursen 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.
- Derived from this study: PubMed 35473589Secher 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
COPD (Chronic Obstructive Pulmonary Disease)
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stine Hangaard, PhD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm in people with Chronic Obstructive Pulmonary Disease and COPD Exacerbation, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbations (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05218525, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.