The primary objective of this study is to evaluate the CoCo application in the regular treatment of the MST and associated physiotherapy practices. We will investigate the use of the application, the application satisfaction, satisfaction of care…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The CoCo application will be evaluated among patients in terms of use of the
application (registered by system), satisfaction with the application (UTAUT),
satisfaction with received care (CSQ), and quality of care (RATER).
Secondary outcome
Outcome measures to evaluate the clinical effects are: exacerbations (number,
duration), amount of activity (accelerometer, BPAQ), exercise tolerance (6MWT),
fatigue (MFI-20), health status and symptoms (CCQ), and quality of life
(EQ-5D).
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. The treatment of COPD aims to reduce risk factors,
prevent disease progression and manage exacerbations. Physiotherapy, increasing
physical participation in daily activities, and early detection and treatment
of exacerbations are important elements of COPD treatment to achieve these
goals, besides medication and smoking cessation. For optimization of COPD
treatment, the treatment programme should be individually based, and is
therefore time- and labour intensive for the patient and the professional.
Home-training programs and self-management of exacerbations have proven to be
effective new treatment methods. If these programmes are offered as a
telemedicine application, they could contribute to a reduction in labour and
costs.
Therefore, the telemedicine application *CoCo* (ConditionCoach) will be used in
the COPD treatment after summer. CoCo supports the treatment of COPD patients
through active self-management and promotion of an active lifestyle. The
healthcare professional can supervise from a distance. To justify the
implementation of the CoCo application in the regular treatment program (on the
long term) and to allow further scaling, evaluation of the deployment of the
CoCo application is important.
Study objective
The primary objective of this study is to evaluate the CoCo application in the
regular treatment of the MST and associated physiotherapy practices. We will
investigate the use of the application, the application satisfaction,
satisfaction of care and quality of care. The secondary aim of this study is to
explore the clinical changes on the health status of the patient by the CoCo
application in the regular treatment. It is expected that the deployment of the
application will have at least similar effects on the patient*s health
(compared to the regular treatment program without using CoCo).
Study design
In a randomised study, the deployment of the CoCo application will be
evaluated. In addition, the changes of the health status by the use of CoCo
will be explored. The following conditions will be compared: 1) regular
treatment program, 2) treatment program with the CoCo application.
Intervention
The CoCo application is a technology-supported care service for self-management
of COPD exacerbations and for promotion of an active lifestyle. The application
consists of three modules: 1) activity registration and feedback, 2) online
webportal with online training program, and 3) self-management of exacerbations
by a triage diary on a smartphone. In addition, CoCo has a telemonitoring
module for the patient and the professional, for monitoring the progress of the
patient, and where the physiotherapist can adjust the training program.
Study burden and risks
The risks associated with participation in the study are minimal. Participants
receive regular treatment and may also use the CoCo modules. These modules
consist of a triage diary for self-management of exacerbations, an online
exercise program and if necessary, activity registration with feedback. The
treatment is supervised by the healthcare professionals. Medication for
self-management of exacerbation is equal to that of the regular treatment. The
application of the activity/training modules are determined by the
physiotherapist based on the physical ability of the patient, therefore
minimizing risks. The exercises from the training program are also used as home
exercises in regular care. Other outcome measures are questionnaires and data
registered by the application. Part of the questionnaires is also frequently
used in regular care.
Roessinghsbleekweg 33b
7522 AH Enschede
NL
Roessinghsbleekweg 33b
7522 AH Enschede
NL
Listed location countries
Age
Inclusion criteria
- a clinical diagnosis of COPD according to the GOLD criteria
- no exacerbation in the month prior to enrolment
- >=3 exacerbations or one hospitalization for respiratory problmens in the two years preceeding study entry
- (ex)smoker
- age>40 years
- post-bronchodilator FEV1 25-80% of predicted
- 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
- uncontrolled diabetes mellitus during a COPD exacerbation in the past or a hospitalization for diabetes mellitus in the two year preceding the study
- need for regular oxygen therapy (>16 h per day or pO2<7.2 kPa)
- maintenance therapy with antibiotics
- 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 |
|---|---|
| ClinicalTrials.gov | NCT10365 |
| CCMO | NL38014.044.11 |