Exacerbation Self-management in COPD: The ACCESS Study

NCT ID: NCT02553096

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-09-30

Brief 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.

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ACCESS

ACCESS is used when participants experience more COPD symptoms.

Group Type: EXPERIMENTAL

ACCESS

Intervention Type: 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.

paper plan

Paper exacerbation action plan is used when participants experience more COPD symptoms.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tjard Schermer, PhD

Role: PRINCIPAL_INVESTIGATOR

head of research unit

Locations

Radboud University Medical Centre, Department of Primary and Community Care

Nijmegen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 23500485 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21920893 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21037270 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24361389 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24183893 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31599729 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30683464 (View on PubMed)

Other Identifiers

NL49741 .091.14

Identifier Type: -

Identifier Source: org_study_id