Our primary aim is to assess the (cost-)effects of the ACCESS system in the support of exacerbation self-management of patients with COPD.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary aim: to improve the number of exacerbation-free weeks.
Secondary outcome
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.
Background summary
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, we have developed the *Adaptive Computerized COPD Exacerbation
Self-management Support* (ACCESS) system. This system is far more advanced than
existing telemonitoring systems. It integrates the outcomes of 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.
Study objective
Our primary aim is to assess the (cost-)effects of the ACCESS system in the
support of exacerbation self-management of patients with COPD.
Study design
This study is a multicenter, pragmatic, two-arm, randomized controlled trial
with a follow-up of 12 months per patient.
Intervention
After a short self-management educational session on
exacerbations, patients 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 receive the instruction to use ACCESS
when they notice a change in COPD symptoms. Patients in the control group
receive the instruction to use their paper action plan when they notice a
change in COPD symptoms.
Study burden and risks
Burden
Before the start of follow-up and after informed consent, all enrolled patients
participate in a 1 hour group meeting addressing early recognition and prompt
treatment of exacerbations. In the intervention group patients receive
instructions from their practice nurse/pulmonary nurse on the use of the ACCESS
system. Patients are asked to use ACCESS whenever they experience acute symptom
worsening. An ACCESS entry takes about 5 minutes. In the control group,
patients receive instructions from their practice nurse/pulmonary nurse on the
use of a paper exacerbation action plan as recommended by current national COPD
guidelines. At three months patients in both groups visit their practice
nurse/pulmonary nurse to evaluate their exacerbation self-management.
For outcome measurements both groups have weekly phone calls from an automated
telephone system (TEXAS) for one year, scheduled on the day and time of the
patient*s preference. This phone call takes about four minutes. All
questionnaires are filled in at baseline and at 12 months of follow-up, except
for COPD specific quality of life and generic quality of life which are also
filled in at three, six and 9 months. At six and nine months a member of the
research team contacts the patients in both groups for research purposes, i.e.
evaluating the questionnaires and the use of the automated exacerbation
assessment system TEXAS.
Risks
The risks in this study are limited. To all participants care as usual is
continued.
Benefits
All participants may benefit from participation, because all patient receive
support in exacerbation self-management. Participants in the intervention group
receive the ACCESS system in addition to usual care. Participants in the
control group receive a paper action plan, which is the recommended care by
current COPD guidelines.
Geert Grooteplein-Noord 21
Nijmegen 6525 EZ
NL
Geert Grooteplein-Noord 21
Nijmegen 6525 EZ
NL
Listed location countries
Age
Inclusion criteria
- age >= 40 years;
- 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
- self-reported co-morbid conditions that prohibit participation;
- unable to communicate in the Dutch language;
- severe difficulties using a smartphone
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49741.091.14 |