To assess whether internet-based telemonitoring of pulmonary function at home can prevent severe pulmonary exacerbations and lead to a reduction of hospital admission in patients with CF.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Number of severe exacerbations; a severe exacerbation is defined as an
exacerbation which requires
treatment with intravenous antibiotic therapy, at the discretion of the
treating lung physician.
* Number of moderate exacerbations; a moderate exacerbation is defined as
exacerbation which allows
treatment with oral antibiotic therapy, at the discretion of the treating
lung physician.
Secondary outcome
* Quality of life, assessed with EQ-5D and Cystic Fibrosis Questionnaire (CFQ).
* Number and route of oral or intravenous antibiotic treatment
* Number of emergency room visits in case of suspicion of pulmonary exacerbation
* Compliance/adherence with self-testing spirometry assessed with a compliance
survey
Background summary
The pathophysiology of CF is characterized by the development of mucus plugging
in the airways and recurring lung infection. This leads to progressive
worsening of the lung function, resulting in damage to the airways and,
ultimately, death. Pulmonary disease in patients with CF is characterized by an
abnormal composition of the epithelial lining fluid. As a result, patients
develop chronic airway infection and inflammation that starts early in life.
During CF exacerbations, there is more sputum and more inflammation. During
these episodes the condition of the patients deteriorates. These episodes are
characterized by increased cough, difficulty to expectorate sputum, loss of
appetite and fatigue, weight loss, decreased quality of life and decreases in
spirometric parameters. Treatment normally consists of a temporarily treatment
with specific antibiotic therapy based on a recent sputum culture. When the
exacerbation is moderate, antibiotic treatment can be given at home (orally or
intravenous), but when the exacerbation is severe, the patient must be admitted
to the hospital for intravenous antibiotic treatment. Hospital admission has a
great impact on the quality of life and well-being of a patient, because
patients have to stay for about 3 weeks in a single room without contact with
other patients to prevent cross-infection. Moreover, it is associated with high
health care costs.Pulmonary function is an important measure of disease
severity and prognosis in CF, and is routinely measured at each clinic visit
every three months with spirometry. It has been suggested that pulmonary
function usually deteriorates earlier than symptoms are perceived and reported.
Recently, a new technology, internet based telemonitoring, has been developed
to monitor pulmonary function at home by means of spirometry self-testing.
Telemonitoring can attribute to an early diagnosis of an exacerbation and early
treatment hereof. Severe exacerbations may be prevented so that the patient can
remain at home as long as possible. This device has been shown useful in
monitoring and treatment of patients with asthma and COPD, but its
effectiveness has not yet been shown in CF patients.
Study objective
To assess whether internet-based telemonitoring of pulmonary function at home
can prevent severe pulmonary exacerbations and lead to a reduction of hospital
admission in patients with CF.
Study design
* Internet-based telemonitoring of pulmonary function by means of spirometry
self-testing
* Lung function measurement will be performed with a handheld spirometer
(Viasys healthcare, AM-2 Plus Pro).
* Each participating patient will be asked to fill in a symptom score
(electronic) and then perform spirometry.
* The data will be transmitted to an external server (by modem) and accesable
by internet afterwards.
* When there is an increase in symptoms or reduction in individual spirometry
values (FEV1, FVC), a CF nurse will contact
the patient by phone. If treatment is indicated, it will be started
immediately.
* In case of non-compliance an alert will be given. The patient will be
contacted by phone to perform spirometry and
assessment of symptoms.
Study burden and risks
* Confrontation with the (true) severity of the disease
* Weekly recurring act (measurement + forwarding)
's Gravendijkwal 230
3015 CE Rotterdam
Nederland
's Gravendijkwal 230
3015 CE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
* Age 18 years or older
* Male or female
* Diagnosis of CF confirmed by sweat-test and/or DNA analysis and/or
electrophysiology testing
* Stable disease
* Signed written informed consent.
Exclusion criteria
*Placing on the High Urgency waiting list for lung transplantation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL20185.078.07 |
| OMON | NL-OMON28124 |