The primary objective of this study is to explore the clinical changes on the health status of the patient. The secondary aim of this study is to evaluate the IS-ACTIVE system with COPD patients. We will investigate the use and usability of the…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome measures to evaluate the clinical changes are: amount of activity
(accelerometer, BPAQ), activity pattern (accelerometer), exercise tolerance
(6MWT), fatigue (MFI-20), health status and symptoms (CCQ), and quality of life
(EQ-5D).
Secondary outcome
The IS-ACTIVE system will be evaluated among patients in terms of use and
usability of the application (registered by system/questionnaire and SUS),
feedback compliance (registred by system), and satisfaction with the system
(UTAUT).
Background summary
Chronic Obstructive Pulmonary Disease (COPD) is a chronic, progressive lung
disease. The prevalence and associated costs of COPD are projected to increase
the upcoming decades. Symptomatic patients with COPD develop dyspnea and are
dyspnoeic even when they perform normal daily activities. This leads to
inactivity and subsequently, to physical deconditioning. A vicious cycle
develops that greatly affects patients* quality of life. The treatment of COPD
aims to reduce risk factors, prevent disease progression and manage
exacerbations. Increasing physical participation in everyday activities is
among the key goals in COPD treatment.
Home-training programs and self-management have proven to be effective new
training methods. Providing feedback to the patient about this physical
activity behaviour is important to stimulate self-management. By focused
feedback, we can try to positively influence the activity pattern, with the
goal to be more physically active in daily life. A prerequisite is that this
should be applied in daily life, so also in the home environment.
The IS-ACTIVE system is an activity coach that promotes an active lifestyle, in
daily life. The aim is that patients become aware of their amount of daily
physical activity and their daily activity pattern, and can improve their
physical activity behaviour. The IS-ACTIVE study was designed because of the
limited knowledge about the impact of feedback on the activity level of COPD
patients on the long term. Besides the aim is to use a new, more intelligent,
type of feedback that promotes COPD patients in having an active lifestyle.
Study objective
The primary objective of this study is to explore the clinical changes on the
health status of the patient. The secondary aim of this study is to evaluate
the IS-ACTIVE system with COPD patients. We will investigate the use and
usability of the application, the application satisfaction, and feedback
compliance.
Study design
In a longitudinal intervention study the IS-ACTIVE system will be evaluated. In
addition, the changes of the health status by the use of IS-ACTIVE will be
explored. The following conditions will be compared: 1) baseline period
(without use of IS-ACTIVE), 2) intervention period (with use of the IS-ACTIVE
activity coach).
Intervention
The IS-ACTIVE system is an application for promotion of an active lifestyle of
COPD patients. The system consists of a smartphone and an activity sensor. The
smartphone displays the amount of measured activity in a graph, together with
the patient*s reference activity (the amount of activity the patient should aim
for) per day. The reference activity is based on the baseline measurement. In
addition, the patient receives feedback messages on the smartphone for extra
motivation. Besides, the patient can log in to a webportal, to see his measured
activity levels. The patient will use this for 3 months, for at least 4 days a
week.
Study burden and risks
The risks associated with participation in the study are minimal. The burden
for patients is limited to wearing the IS-ACTIVE activity coach (smartphone and
sensor). Based on the feedback, the patients are encouraged to be more
physically active with a more even distribution over the day. The use of the
IS-ACTIVE activity coach is adapted to the physical capabilities of the
individual patient, minimizing the risks. Other outcome measures are
questionnaires and data registered by the system. Part of the questionnaires is
also frequently used in regular care.
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
- a clinical diagnosis of COPD according to the GOLD criteria, GOLD II-IV
- no exacerbation in the month prior to measurement
- (ex)smoker
- age>40 years
- able to understand and read Dutch
- internet access at home
Exclusion criteria
-serious other disease with a low survival rate
-other diseases influencing bronchial symptoms and/or lung function (e.g. cardiac insuficiency, sarcoidosis)
- severe psychiatric illness
- need for regular oxygen therapy (>16 h per day or pO2<7.2 kPa)
- known alpha1-antitrypsine deficiency
- disorders or progressive disease seriously influencing daily activities (e.g. amputation, paralysis, progressive muscle disease)
- impaired hand function causing inability to use application
Design
Recruitment
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 | NL38996.044.11 |