The first aim of this study is to determine the prevalence of cognitive impairment in COPD patients compared with persons without COPD. The second aim is to study the clinical characteristics of COPD patients with cognitive impairment. The third aim…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
4 compound scores for the cognitive domains: motor speed, memory, cognitive
flexibility and planning. Furthermore: general cognitive functioning (cognitive
index; MMSE)), IQ (GIT) and subjective cognitive functioning (CFQ).
Secondary outcome
* Demographics: age, level of education and social status.
* Clinical characteristics:
- General psychological functioning: Symptom Checklist-90, Hospital Anxiety and
Depression scale, Beck Depression Inventory, Utrecht coping list, Dutch
personality questionnaire en St George's Respiratory Questionnaire.
- Other clinical characteristics: blood gasses, comorbidities (Charlson
comorbidity index), pulmonary function, diffusion capacity, saturation measure,
Obstructief Slaap Apneu Syndroom, medication, oxygen therapy, smoking
behaviour, Body Mass Index, knowlegde about the lung disease, educational needs
and exercise capacity (6-minute walking distance test).
* Problematic activities of daily life (*Canadian Occupational Performance
Measure*).
* Patient information needs (Lung Information Needs Questionnaire).
* Brain abnormalities, including brain atrophy, white matter lesions,
hippocampal volume, vascular abnormalities, structural connectivity and
functional connectivity
Background summary
Patients with Chronic Obstructive Pulmonary Disease (COPD) may experience
dyspnoea, fatigue and problems in daily functioning, despite optimal
pharmacological treatment. It is important that patients follow a number of
precepts in order to minimize the consequences of the illness. Before a patient
is willing to follow the precepts, a patient needs to experience that the new
behaviour yields more advantages, compared to the old behaviour. Patients need
specific cognitive abilities in order to make a considered choice. 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.
Study objective
The first aim of this study is to determine the prevalence of cognitive
impairment in COPD patients compared with persons without COPD. The second aim
is to study the clinical characteristics of COPD patients with cognitive
impairment. The third aim is to assess whether and to what extent cognitive
functioning is related to daily functioning in COPD patients entering pulmonary
rehabilitation. The fourth aim is to assess whether and to what extent
cognitive functioning may influence important outcome parameters of pulmonary
rehabilitation: general psychological functioning, knowledge about COPD, daily
functioning and exercise capacity. The fifth aim is to study brain
abnormalities in patients with COPD and the relationship with cognitive
functioning and daily functioning.
Study design
The study concerns a longitudinal observational study of COPD patients during
pulmonary rehabilitation. For each patient recruited in the longitudinal study
a matched control will be searched for. Cognitive functioning at baseline in
this subgroup will be compared with cognitive functioning in the matched
controls. In 70 patients of the longitudinal study, a brain MRI will be
performed.
Study burden and risks
This study will provide more insight in cognitive functioning of patients with
COPD. This insight will help us to improve management programmes for COPD
patients. Risks for participants are minimal. Patients have no individual
benefit from participation.
Hornerheide 1
Horn 6085 NM
NL
Hornerheide 1
Horn 6085 NM
NL
Listed location countries
Age
Inclusion criteria
Patients:
* Diagnosis: COPD according to the Global Initiative For Chronic Obstructive Lung Disease (GOLD) definition;Matched control group:
* Smoking status comparable with smoking status from included patient (current smoker; non smoker; former smoker)
Exclusion criteria
Patients:
* Patient is not clinically stable during 4 weeks preceding enrolment
* Previous diagnosis of dementia
* Patient does not speak Dutch well enough to participate ;Brain MRI patient group:
* The patient has a pacemaker or a cochlear implant
* The patient has a neurostimulator or other electronic implants
* The patient ever had surgery with metal implants (e.g. a magnetic implant within the jaw)
* The patient ever had a metal splinter in the eye
* The patient suffers from claustrophobia ;Matched control group:
* Diagnoses of COPD or Asthma
* Previous diagnosis of dementia
* Participant does not speak Dutch well enough to participate
* Age of the matched control differ more than 10 years from the age of the patient for who he/she was matched
* Level of education of the matched control differs more than 1 level from the level of education for who he/she was matched (according to the scoring system of the CBS).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45127.068.13 |
| OMON | NL-OMON23902 |