Exacerbation Self-management in COPD: The ACCESS Study
Exacerbation Self-management in COPD: The ACCESS Study
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.
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;