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Aim is to test the effect of ACCESS ("Adaptive Computerized COPD Exacerbation Self-management Support"), a software application designed to support patients with COPD in self-management of exacerbations.
Rationale: COPD exacerbations considerably affect patients' health status and contribute to COPD related costs. Patients often have problems in recognizing and responding promptly to exacerbations. Tools that support patients in exacerbation self-management such as paper exacerbation action plans and telemonitoring systems have shown some positive results on exacerbation related outcomes. However, many patients appear not to adhere to their action plan instructions. Besides, existing telemonitoring tools rely heavily on the input of healthcare professionals which makes it difficult to assess the true effects and cost effectiveness of telemonitoring systems.
Recently, the Radboud University has developed the "Adaptive Computerized COPD Exacerbation Self-management Support" (ACCESS) system. This software application integrates objective parameters, such as spirometry, pulse-oximetry, temperature, and self-reported symptom worsening into a Bayesian network model resulting in a weighted exacerbation risk prediction. Patients are able to monitor themselves at any given moment. The ACCESS system not only predicts whether an exacerbation is imminent, but also provides ad hoc tailored advice without interference of a healthcare professional.
Objective: In this project the primary aim is to assess the (cost-)effectiveness of the ACCESS system in the support of exacerbation self-management in patients with COPD.
Study design: A multicenter, pragmatic, two-arm, randomized controlled trial with a follow-up of 12 months per participant.
Study population: Patients with COPD, > 40 years old, with 2 or more self-reported symptom based exacerbations in the previous year.
Intervention: After a short self-management educational session on exacerbations, participants are randomized to either 1) exacerbation self-management support through the use of a paper exacerbation action plan (control group); or 2) exacerbation self-management support through the use of the ACCESS system (intervention group).
Participants in the intervention group are instructed to use ACCESS when they notice a change in COPD symptoms. Participants in the control group are instructed to use their paper action plan when they notice a change in COPD symptoms.
Main study parameters/endpoints:
Primary aim: to increase the number of exacerbation-free weeks. Secondary aims: to improve exacerbation self-management, exacerbation-management related self-efficacy, and quality of life. To decrease ER visits, hospital admissions and COPD related costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACCESS | Experimental | ACCESS is used when participants experience more COPD symptoms. |
|
| paper plan | No Intervention | Paper exacerbation action plan is used when participants experience more COPD symptoms. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACCESS | Device | The ACCESS system consists of a smartphone, a pulse-oximeter, a spirometer and a forehead thermometer. Questions concerning changes in symptoms, physical limitations and emotions are answered by touch screen on the smartphone, complemented by measurements of the pulse-oximeter, spirometer and thermometer. Based on this information, the system calculates the current risk of an exacerbation and, when applicable, the participant will receive personalized instructions about which actions to take in order to manage the exacerbation. Participants are instructed to use ACCESS in case of symptom worsening. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of exacerbation-free weeks | Measured with the Telephonic EXacerbation Assessment System (TEXAS) [Bischoff, ERJ, 2012] | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in exacerbation-related self-management behaviour | Prompt reaction and adequate response to symptoms, measured with the Telephonic EXacerbation Assessment System (TEXAS) [Bischoff, ERJ, 2012] | 1 year |
| Improvement in Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tjard Schermer, PhD | head of research unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Centre, Department of Primary and Community Care | Nijmegen | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23500485 | Background | van der Heijden M, Lucas PJ, Lijnse B, Heijdra YF, Schermer TR. An autonomous mobile system for the management of COPD. J Biomed Inform. 2013 Jun;46(3):458-69. doi: 10.1016/j.jbi.2013.03.003. Epub 2013 Mar 15. | |
| 21920893 | Background | Bischoff EW, Boer LM, Molema J, Akkermans R, van Weel C, Vercoulen JH, Schermer TR. Validity of an automated telephonic system to assess COPD exacerbation rates. Eur Respir J. 2012 May;39(5):1090-6. doi: 10.1183/09031936.00057811. Epub 2011 Sep 15. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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2-block randomised trial
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|
Measured with the Nijmegen Clinical Screening Instrument (NCSI)
| 1 year |
| Improvement in Quality of Life | Measured with the Clinical COPD Questionnaire (CCQ) | 1 year |
| Improvement in Quality of Life | Measured with the Euroqol -5 dimensions (EQ-5d) | 1 year |
| Improvement in self-efficacy | Measured with an exacerbation-related self-efficacy scale | 1 year |
| Number of ER visits and hospital admissions | Measured with hospital and general practice medical records | 1 year |
| Cost-effectiveness of ACCESS; ratio calculated with the use of medical records and questionnaires. | Costs consist of health care utilisation and patients' productivity losses, effectiveness is measured with EQ-5d. | 1 year |
| 21037270 | Background | Bischoff EW, Hamd DH, Sedeno M, Benedetti A, Schermer TR, Bernard S, Maltais F, Bourbeau J. Effects of written action plan adherence on COPD exacerbation recovery. Thorax. 2011 Jan;66(1):26-31. doi: 10.1136/thx.2009.127621. Epub 2010 Oct 30. |
| 24361389 | Background | van der Heijden M, Velikova M, Lucas PJ. Learning Bayesian networks for clinical time series analysis. J Biomed Inform. 2014 Apr;48:94-105. doi: 10.1016/j.jbi.2013.12.007. Epub 2013 Dec 18. |
| 24183893 | Background | van der Heijden M, Lucas PJ. Describing disease processes using a probabilistic logic of qualitative time. Artif Intell Med. 2013 Nov;59(3):143-55. doi: 10.1016/j.artmed.2013.09.003. Epub 2013 Oct 7. |
| 31599729 | Derived | Boer L, Bischoff E, van der Heijden M, Lucas P, Akkermans R, Vercoulen J, Heijdra Y, Assendelft W, Schermer T. A Smart Mobile Health Tool Versus a Paper Action Plan to Support Self-Management of Chronic Obstructive Pulmonary Disease Exacerbations: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Oct 9;7(10):e14408. doi: 10.2196/14408. |
| 30683464 | Derived | Liu M, Stella F, Hommersom A, Lucas PJF, Boer L, Bischoff E. A comparison between discrete and continuous time Bayesian networks in learning from clinical time series data with irregularity. Artif Intell Med. 2019 Apr;95:104-117. doi: 10.1016/j.artmed.2018.10.002. Epub 2019 Jan 22. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |