|- candidate number||23377|
|- NTR Number||NTR5626|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-nov-2015|
|- Secondary IDs||2014.498 METC|
|- Public Title||GOLD D Patients in Primary Care: A Group Whose Clinical Outcomes Can Easily Be Improved|
|- Scientific Title||GOLD D Patients in Primary Care: A Group Whose Clinical Outcomes Can Easily Be Improved|
|- hypothesis||We 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 received||yes|
|- multicenter trial||no|
|- planned startdate ||1-feb-2015|
|- planned closingdate||1-nov-2017|
|- Target number of participants||56|
|- Interventions||Treatment in the integrated care system of Certe (AC Service) for 12 months|
|- Primary outcome||WP1:|
- We aim to describe the baseline characteristics of GOLD D patients.
-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 outcome||WP1:|
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.
• 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.
|- Timepoints||Last patient in: january 2016|
Last patient last visit: april 2017
Final publication ready for submission: november 2017
|- Trial web site||-|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. C. Jong, de|
|- CONTACT for SCIENTIFIC QUERIES||Drs. C. Jong, de|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||10-nov-2015 - 27-feb-2016|