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Cognitive functioning in COPD patients.


- candidate number12071
- NTR NumberNTR3352
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-mrt-2012
- Secondary IDs11-3-054 METC Maastricht
- Public TitleCognitive functioning in COPD patients.
- Scientific TitleCognitive functioning in COPD patients and its influence on health status, daily functioning and treatment.
- ACRONYM
- hypothesis1. To determine the prevalence of cognitive impairment in COPD patients and to look for clinical characteristics of COPD patients with cognitive impairment;
2. To study the influence of cognitive functioning on daily functioning and treatment outcomes;
3. To study the needs for information;
4. Possibility to participate as an active partner in health care.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD), Cognitive functioning
- Inclusion criteriaPatients:
1. Diagnosis: COPD according to the Global Initiative For Chronic Obstructive Lung Disease (GOLD) definition.

Matched control group:
1. Partner, brother or sister of an included patient;
2. Smoking status comparable with smoking status form included patient (current smoker; non smoker; former smoker).
- Exclusion criteriaPatients:
1. Patient is not clinically stable during 4 weeks preceding enrolment;
2. Previous diagnosis of dementia;
3. Patient does not speak Dutch well enough to participate;
4. At the moment of testing, patients who were referred by their general practitioner but are also treated by a chest physician or are currently referred for pulmonary rehabilitation;
5. At the moment of testing, patients who were referred by the chest physician but are also referred for pulmonary rehabilitation.

Matched control group:
1. Diagnoses of COPD or Asthma;
2. Previous diagnosis of dementia;
3. Participant does not speak Dutch well enough to participate;
4. Age of the matched control differ more than 10 years from the age of the patient for who he/she was matched;
5. Level of education of the matched control differ more than 3 levels from the level of education for who he/she was matched.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2012
- planned closingdate1-dec-2014
- Target number of participants345
- InterventionsN/A
- Primary outcomeRaw scores on the different subtest of the neuropsychological test battery and 5 compound scores for different cognitive domains.
- Secondary outcomeDemographics, clinical characteristics, problematic activities of daily life, patient information needs, enablement to participate as an active partner in health care and expectations and views of the caregiver with respect to participation of the patient as an active partner in health care.
- TimepointsWe will use questionaires, a neuropsychological testbattery, a 6-minute walk test, spirometry, blood tests and other measures which are part of clinical practice.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Candy Gijsen
- CONTACT for SCIENTIFIC QUERIESMD. PhD. D.J.A. Janssen
- Sponsor/Initiator CIRO+ (Centre of expertise for chronic organ failure)
- Funding
(Source(s) of Monetary or Material Support)
CIRO+
- PublicationsN/A
- Brief summaryRationale:
Previous research suggests that the cognitive functions of COPD patients may be impaired. However, results of previous research are disputable. To date, remains unclear which clinical characteristics are related to cognitive functioning in COPD patients and whether and to what extent cognitive functioning is related to daily functioning, health status and the outcome of pulmonary rehabilitation.

Objective:
To determine the prevalence of cognitive impairment in COPD patients and to look for clinical characteristics of COPD patients with cognitive impairment. To study the influence of cognitive functioning on daily functioning and treatment outcomes.To study the needs for information and possibility to participate as an active partner in health care.

Study design:
The study consists of an observation comparable study and an observation study with repeated measures.

Study population:
255 COPD patients and 90 healthy controls.

Primary study parameters:
Raw scores on the different subtest of the neuropsychological test battery and 5 compound scores for different cognitive domains.
- Main changes (audit trail)
- RECORD16-mrt-2012 - 29-mrt-2012


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