Chronic Obstructive Pulmonary Disease, COPD Exacerbation, COPD Exacerbation Acute, COPD
Conditions
Keywords
chronic obstructive pulmonary disease, Denmark, acute episodes, machine learning, telehealth, telemonitoring, RCT, decision support systems, predictive analytics
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.
Interventions
OTHERAlgorithm
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.
Sponsors
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
A prospective, parallel two-armed randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exacerbations | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health literacy level | Baseline | 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 |
| Evaluation of the participants' experience with data ethical aspects | 6 months follow-up | To evaluate the participants' experiences with data ethical aspects after trial completion using qualitative research interviews |
| Estimation of the specialized COPD community nurse's level of participant's health literacy | Through study completion, an average of six months | 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 |
| Evaluation of the specialized COPD community nurses' experiences with the usability of the COPD prediction algorithm | 6 months follow-up | To evaluate the specialized COPD community nurses' experiences with the usability of the COPD prediction algorithm using interviews |
| Evaluation of the participants experiences' with the usability of the telehealth system | 6 months follow-up | To evaluate the participants' experiences with the usability of the telehealth system after trial completion using the questionnaire D-TUQ |
Countries
Denmark
Outcome results
None listed