1. To improve patient's quality of life in a cost-effective way by a self-management programme guided by doctors and a specialist asthma nurse through information and communication technology. 2. To investigate whether a simple index of asthma…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary and secondary outcome are health related quality of life (PAQLQ)
and asthma control (ACQ), respectively.
Economic evaluation
The costs of usual care and ICT-supported care will be compared from a societal
perspective. In a cost-utility analysis, the difference in societal costs will
be related to the estimate difference in QALYs using acceptability curves. A
Markov model will be used to extrapolate the trial data to a 3 year period.
Secondary outcome
self-management behaviour
QALY (for cost-effectiveness analysis)
inhalation technique (assessed by nurse)
health care utilization
knowledge of asthma
lung function and daily symptoms
self-efficacy
asthma control by other instruments
Background summary
Self-management of asthma is of proven effectiveness, but is seldom done by
patients. This study aims at making self-management easier by simplifying
monitoring of symptoms and lung function, and by supporting decisions on
increasing or decreasing medication.
Study objective
1. To improve patient's quality of life in a cost-effective way by a
self-management programme guided by doctors and a specialist asthma nurse
through information and communication technology.
2. To investigate whether a simple index of asthma control and/or patient
characteristics can be used to predict efficiency of such a guided
self-management programme in order to target cost-effective implementation.
3. To assess the characteristics and reasons for not participating of eligible
patients.
4. To assess the agreement between actual and perceived control of asthma.
Study design
A randomised parallel trial with 2 arms and 1 year follow-up in 3 phases in
order to compare ICT-supported care with usual care. The first phase aims at
selecting eligible patients. The second phase serves as a baseline period and
is solely aimed at collecting data on asthma control and behaviour and
lifestyle, and predisposing, reinforcing and enabling factors. The third phase
includes the intervention and evaluation period.
Intervention
The current intervention is additional to usual care and includes monitoring of
symptoms and lung function and communication of results, feedback and reminders
via internet and short message services on telephones. The service is
supervised by a specialised nurse and facilitates discussion groups, a chat box
and consultation via private messaging. Asthma self-management education and
training sessions are given by a specialist nurse.
Study burden and risks
questionnaires on asthma control, total 15'-20' in phase 1
3x set of questionnaires, total 30'-45' for each set, in phase 2/3
*see p23, attachment 4 for details on assessment schedule
oral explanation about goal of phase 2/3 + check inhalation technique (total 1
hour)
2 education sessions of 1,5 - 2 hour (intervention group only)
3x 2 weeks daily symptomscore / lungfunction (1' to 3' each day)
52x weekly lungfunction + asthma-control questionnaire (online) invullen (3'-5'
each week) (intervention group only)
no known risks
postbus 9600
2300 RC Leiden
Nederland
postbus 9600
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
* age 12-17 year
* doctors diagnosis of asthma
* mild to severe persistent asthma (patients who need inhaled corticosteroids as controller medication)
* at least one asthma control problem (Asthma Therapy Assessment Questionnaire-score *1 or Asthma Control Questionnaire *1.0)
* PC with internet connection available
* able to communicate in the Dutch language
.
Exclusion criteria
Patients requiring oral corticosteroids as controller medication and patients with relevant comorbidity
Design
Recruitment
metc-ldd@lumc.nl
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 | NL13115.058.06 |