Exacerbation Self-management in COPD: The ACCESS Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: ACCESS


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2-block randomised trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACCESS<br>ACCESS is used when participants experience more COPD symptoms. | Device: ACCESS<br>* 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.<br>|
| No Intervention: paper plan<br>Paper exacerbation action plan is used when participants experience more COPD symptoms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbation-free weeks | Measured with the Telephonic EXacerbation Assessment System (TEXAS) [Bischoff, ERJ, 2012] | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exacerbations, self-management support, software application