Exacerbation Self-management in COPD: The ACCESS Study

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Device: ACCESS

• Registration Number: NCT02553096
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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).

Read More

Exclusion Criteria

• severe co-morbid conditions that prohibit participation;
• unable to communicate in the Dutch language;
• difficulties using a smartphone;

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACCESS	ACCESS	ACCESS is used when participants experience more COPD symptoms.

Primary Outcome Measures

Name	Time	Method
Number of exacerbation-free weeks	1 year	Measured with the Telephonic EXacerbation Assessment System (TEXAS) \[Bischoff, ERJ, 2012\]

Secondary Outcome Measures

Name	Time	Method
Improvement in exacerbation-related self-management behaviour	1 year	Prompt reaction and adequate response to symptoms, measured with the Telephonic EXacerbation Assessment System (TEXAS) \[Bischoff, ERJ, 2012\]
Improvement in Quality of Life	1 year	Measured with the Euroqol -5 dimensions (EQ-5d)
Improvement in self-efficacy	1 year	Measured with an exacerbation-related self-efficacy scale
Number of ER visits and hospital admissions	1 year	Measured with hospital and general practice medical records
Cost-effectiveness of ACCESS; ratio calculated with the use of medical records and questionnaires.	1 year	Costs consist of health care utilisation and patients' productivity losses, effectiveness is measured with EQ-5d.

Trial Locations

Locations (1)

Radboud University Medical Centre, Department of Primary and Community Care; 🇳🇱 Nijmegen, Netherlands