Exacerbation Self-management in COPD: The ACCESS Study

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— ACCESS  

Official title:

Adaptive Computerized COPD Exacerbation Self-management Support (ACCESS): A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02553096
• Other study ID #: NL49741 .091.14
• Status: Active, not recruiting
• Phase: N/A
• First received: August 5, 2015
• Last updated: August 29, 2017
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: August 2017
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 87
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• confirmed diagnosis of COPD by spirometry (post-bronchodilator FEV1/FVC < 0.70);

• at least 2 self-reported exacerbations in the previous 12 months, i.e. a change for = 2 consecutive days in either = 2 major symptoms (dyspnea, sputum purulence, sputum amount) or any 1 major symptom plus any = 1 minor symptoms (colds, wheeze, sore throat, cough).

Exclusion Criteria:

• severe co-morbid conditions that prohibit participation;

• unable to communicate in the Dutch language;

• difficulties using a smartphone;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• ACCESS
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.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre, Department of Primary and Community Care	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of exacerbation-free weeks	Measured with the Telephonic EXacerbation Assessment System (TEXAS) [Bischoff, ERJ, 2012]	1 year
Secondary	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
Secondary	Improvement in Quality of Life	Measured with the Nijmegen Clinical Screening Instrument (NCSI)	1 year
Secondary	Improvement in Quality of Life	Measured with the Clinical COPD Questionnaire (CCQ)	1 year
Secondary	Improvement in Quality of Life	Measured with the Euroqol -5 dimensions (EQ-5d)	1 year
Secondary	Improvement in self-efficacy	Measured with an exacerbation-related self-efficacy scale	1 year
Secondary	Number of ER visits and hospital admissions	Measured with hospital and general practice medical records	1 year
Secondary	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