The aim of the current study is evaluation of the Certe A/C service system. This is achieved via 2 workpackages:Workpackage 1 constitutes of describing patient characteristics (age, gender, current medication, smoking status and comorbidities) of…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Workpackage 1: describing patient characteristics (age, gender, smoking status,
medication use and comorbidities) of group D patients in comparison to group A,
B and C patients and the representativeness of group D on a global scale using
the large database from the UNLOCK initiative.
Primary outcome in workpackage 1 is: a description of baseline characteristics
of the primary care group D COPD patients
Workpackage 2: evaluating health status and exacerbation rate in group D
patients after 12 months treatment in the AC service. This workpackage focusses
on validating current identified phenotypes that are associated with clinically
relevant improvement in health status, exacerbations, health care costs and
medication use. Data from usual care from group A, B and C will be used as
comparison.
Primary outcome in workpackage 2 is: the difference in health status between
the baseline and final follow-up visit at 12 months as measured by the Clinical
COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT).
Secondary outcome
Workpackage1:
Secondary outcomes:
• A comparison of baseline characteristics of GOLD D patients with baseline
characteristics of the GOLD ABC patients
• Compare group D patients using either CCQ>=1 or CAT >=10.
• Evaluating the representativeness of the AC service patients on a global
scale. By comparing the characteristics of the AC service patients with
those of the UNLOCK initiative patients.
Workpackage 2:
Secondary outcomes:
• Identifying patient characteristics that are associated with a change in
quality of life (thereby validating current identified patient phenotypes).
• Differences in number of exacerbations between the year preceding the study
and the follow-up period.
• Differences in health care costs between the year preceding the study and the
follow-up period.
• Differences in medication use between the year preceding the study and the
follow-up period.
• Differences in patient characteristics of group D patients compared to group
A, B and C patients.
• Identifying patient characteristics that dissociate between patients that
change from group D to group A, B or C within the follow-up year and patients
that remain in group D within that year. Using solely data from usual care,
this will be evaluated as well for patients in groups A, B and C.
Background summary
A recently published study shows that the prevalence of patients receiving
inhaled medication is low, with almost 50% of COPD patients in group D not
being treated at all, indicating gross undertreatment. Further information on
this group is very scarce, even though this group is prevalent in primary care.
Providing adequate treatment, including appropriate medication, in an
integrated care environment might greatly enhance health status and reduce
exacerbations in this group.
Study objective
The aim of the current study is evaluation of the Certe A/C service system.
This is achieved via 2 workpackages:
Workpackage 1 constitutes of describing patient characteristics (age, gender,
current medication, smoking status and comorbidities) of group D patients in
comparison to the GOLD A, B and C and describing representativity on a global
scale. This will ascertain external validity of the results.
Workpackage 2 comprises of the evaluation of health status and exacerbation
rate of group D patients before and after 12 months treatment in an integrated
care system. The focus in workpackage 2 lies on individual patient centered
treatment by validating current identified patient phenotypes. During the 12
months follow-up period, information will be collected regarding lung function,
health status, medication use (type of medication, daily dose, device used and
adherence), inhalation technique, exacerbations, health care costs (direct
primary and secondary health care usage, medication costs and indirect costs
related to lost work), QALYs and a full blood count (especially eosinophil and
neutrophil). Additionally, data from usual care from group A, B and C will be
used as comparison.
Study design
Design:
This study is an prospective observational study that will be performed at the
department of primary care at the University Medical Center Groningen, the
Groningen Research Institute for Asthma and COPD and the local laboratory,
Certe .
Assessment of representativeness will be accomplished with use of the UNLOCK
initiative comprised of datasets from: United Kingdom, the Netherlands, Sweden,
Norway, Spain, Belgium, Greece, Ukraine, Canada and Australia.
Study burden and risks
Only the participants in workpackage 2 are subject to potentially additional
burden and risks.
Visit 1, the venipuncture is associated with slight risks, they may include:
Excessive bleeding
Fainting or feeling light-headed
Hematoma (blood accumulating under the skin)
There are 3 extra telephone interviews, after 3 , 6 and 9 months. Each will
last maximally 15 minutes.
Hanzeplein 1
Groningen 9700AD
NL
Hanzeplein 1
Groningen 9700AD
NL
Listed location countries
Age
Inclusion criteria
- Age>40
- Diagnosis COPD (workpackage 1) and COPD group D (workpackage 2)
Exclusion criteria
- Asthma diagnosis, asthma/COPD overlap syndrome or other respiratory illnesses
- Inability to complete questionnaires due to either language difficulties or cognitive problems
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 | NL50820.042.14 |