Chronic Obstructive Pulmonary Disease (COPD)ACCESSNCT02553096
Exacerbation Self-management in COPD: The ACCESS Study
A study testing ACCESS in people with Chronic Obstructive Pulmonary Disease (COPD), run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- ACCESS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to Sep 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- severe co-morbid conditions that prohibit participation;
- unable to communicate in the Dutch language;
- difficulties using a smartphone;
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Centre, Department of Primary and Community Care
Nijmegen, 6500 HB
About this study
Official title: Adaptive Computerized COPD Exacerbation Self-management Support (ACCESS): A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- ACCESS
- Keywords
- exacerbations, self-management support, software application
- 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.
ACCESSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ACCESS | Experimental | ACCESS is used when participants experience more COPD symptoms. Receives: Device: ACCESS |
| paper plan | No intervention | Paper exacerbation action plan is used when participants experience more COPD symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exacerbation-free weeks
Measured with the Telephonic EXacerbation Assessment System (TEXAS) [Bischoff, ERJ, 2012]
Measured: 1 year
Secondary outcomes (7)
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]
Measured: 1 year
Improvement in Quality of Life
Measured with the Nijmegen Clinical Screening Instrument (NCSI)
Measured: 1 year
Improvement in Quality of Life
Measured with the Clinical COPD Questionnaire (CCQ)
Measured: 1 year
Improvement in Quality of Life
Measured with the Euroqol -5 dimensions (EQ-5d)
Measured: 1 year
Improvement in self-efficacy
Measured with an exacerbation-related self-efficacy scale
Measured: 1 year
Number of ER visits and hospital admissions
Measured with hospital and general practice medical records
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2017
- Study completionSep 2017 (estimated)
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 Disease (COPD)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-block randomised trial
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjard Schermer, PhD, Principal investigator, head of research unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553096
- Sponsor's protocol ID
- NL49741 .091.14
- Acronym
- ACCESS
- Status last verified
- Aug 2017
- First submitted
- 5 Aug 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23500485Bischoff 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.
PubMed 21920893Bischoff 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.
PubMed 21037270van 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.
PubMed 24361389van 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.
PubMed 24183893Boer 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.
PubMed 31599729Liu 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.
PubMed 30683464
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Computerized COPD Exacerbation Self-management Support (ACCESS): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02553096
- Acronym / sponsor ID
- ACCESS / NL49741 .091.14
- Keywords
- exacerbations, self-management support, software application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (estimated)
- First posted
- 17 Sep 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-block randomised trial
| Arm | Type | Receives |
|---|---|---|
| ACCESS | Experimental | Device: ACCESSACCESS is used when participants experience more COPD symptoms. |
| paper plan | No intervention | –Paper exacerbation action plan is used when participants experience more COPD symptoms. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- severe co-morbid conditions that prohibit participation;
- unable to communicate in the Dutch language;
- difficulties using a smartphone;
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 |
|---|---|---|
| ACCESSThe 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. | Device | ACCESS |
Primary outcome
Number of exacerbation-free weeks
Time frame: 1 year
Measured with the Telephonic EXacerbation Assessment System (TEXAS) [Bischoff, ERJ, 2012]
7 secondary outcomes
Improvement in exacerbation-related self-management behaviour
Time frame: 1 year
Improvement in Quality of Life
Time frame: 1 year
Improvement in Quality of Life
Time frame: 1 year
Improvement in Quality of Life
Time frame: 1 year
Improvement in self-efficacy
Time frame: 1 year
Number of ER visits and hospital admissions
Time frame: 1 year
Cost-effectiveness of ACCESS; ratio calculated with the use of medical records and questionnaires.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Background: PubMed 23500485van 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.
- Background: PubMed 21920893Bischoff 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.
- Background: PubMed 21037270Bischoff 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.
- Background: PubMed 24361389van 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.
- Background: PubMed 24183893van 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.
- Derived from this study: PubMed 31599729Boer 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.
- Derived from this study: PubMed 30683464Liu 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.
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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.
Tjard Schermer, PhD principal investigator
head of research unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACCESS in people with Chronic Obstructive Pulmonary Disease (COPD), run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Aug 2017. 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 Netherlands. 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?
Results are not available in the source record.
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?
Number of exacerbation-free weeks (time frame: 1 year). 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 NCT02553096, 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 30 Aug 2017; AzTrials last refreshed its copy on 26 Oct 2026.