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GOLD D in primary care: a group whose clinical outcomes can easily be improved

GOLD D in primary care: a group whose clinical outcomes can easily be improved - GOLD D in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41773
Enrollment
56
Registered
2015-03-04
Start date
2015-03-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease COPD

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age>40 - Diagnosis COPD (workpackage 1) and COPD group D (workpackage 2)

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)