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GOLD D Patients in Primary Care: A Group Whose Clinical Outcomes Can Easily Be Improved


- candidate number23377
- NTR NumberNTR5626
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-nov-2015
- Secondary IDs2014.498 METC
- Public TitleGOLD D Patients in Primary Care: A Group Whose Clinical Outcomes Can Easily Be Improved
- Scientific TitleGOLD D Patients in Primary Care: A Group Whose Clinical Outcomes Can Easily Be Improved
- ACRONYM
- hypothesisWe hypothesise that accurate treatment of GOLD D patients in an integrated primary care system will improve patient outcomes over 12 months.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria Age > 40 (all patients)
Diagnosed COPD (work package 1)
Diagnosis compatible with GOLD D classification (work package 2)
- Exclusion criteria Asthma diagnosis, asthma/COPD overlap syndrome or other respiratory illnesses
Inability to complete questionnaires due to language or cognitive difficulties
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-feb-2015
- planned closingdate1-nov-2017
- Target number of participants56
- InterventionsTreatment in the integrated care system of Certe (AC Service) for 12 months
- Primary outcomeWP1:
- We aim to describe the baseline characteristics of GOLD D patients.
WP2:
-We aim to identify the difference in health status between baseline and final follow up at 12 months, as measured by the CCQ and CAT.
- Secondary outcomeWP1:
We will compare the baseline characteristics of GOLD D patients with those of GOLD group A, B, and C patients.
We will compare GOLD D patients as assessed using either CCQ ≥ 1 or CAT ≥ 10 criteria.
We will evaluate how representative the Certe AC Service patients are of the wider COPD population by comparing their characteristics with those of patients in the UNLOCK initiative. WP2:
We aim to identify the patient characteristics associated with changes in quality of life, thereby seeking to validate the known patient phenotypes, such as frequent exacerbators, patients with rapid decline in FEV1, patients with low body mass index, and those with poor exercise capacity. Gold D in primary care Version 3, 10th June 2015 12 of 28
We will compare the following variables between the year preceding the study and the study period:
o Differences in exacerbation rates;
o Differences in health care costs;
o Differences in medication use; and
o Differences in patient characteristics between gold d and gold a, b and c patients.
Using data based on their usual care, we also aim to identify the characteristics of patients that change classification within the study period, as follows:
o Those changing from GOLD D to another GOLD group (A, B, or C) versus those that remain unchanged, and;
o Those changing from GOLD group A, B or C to another GOLD group versus those that remain unchanged.
- TimepointsLast patient in: january 2016
Last patient last visit: april 2017
Final publication ready for submission: november 2017
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. C. Jong, de
- CONTACT for SCIENTIFIC QUERIESDrs. C. Jong, de
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD10-nov-2015 - 27-feb-2016


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