NCT02143700

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic condition involving an impairment in functionality and in the execution of activities of daily life. The hypothesis of this study is to examine the relationship between cognitive status and clinical profile (respiratory, sleep quality, nutritional status) in patients with chronic obstructive pulmonary disease in two different moments: exacerbation or stable situation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

May 17, 2014

Last Update Submit

May 17, 2014

Conditions

Keywords

exacerbationcognitivechronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

  • Cognitive impairment

    The cognitive impairment will be measured using the Montreal Cognitive Assessment. The Montreal Cognitive Assessment is a test designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

    Baseline

Secondary Outcomes (10)

  • Sleep quality

    Baseline

  • Activity monitoring

    Baseline

  • Nutritional state

    Baseline

  • Quality of life

    Baseline

  • Cough

    Baseline

  • +5 more secondary outcomes

Study Arms (1)

Stable and exacerbated patients

Patients diagnosed of chronic obstructive pulmonary disease in a stable or exacerbated situation. Cognitive assessment of these patients will be performed.

Other: Cognitive assessment

Interventions

Patients are going to be assessed regarding the outcome measures

Also known as: assessment, observation, evaluation
Stable and exacerbated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed of chronic obstructive pulmonary disease.

You may qualify if:

  • Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation or stable.
  • Signed written consent.

You may not qualify if:

  • Heart disease.
  • Neurological patients.
  • Severe cognitive impairment in order not to complete the assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, Granada, 18071, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Mental Status and Dementia TestsRestraint, PhysicalObservation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesBehavior ControlTherapeuticsImmobilizationInvestigative TechniquesMethods

Central Study Contacts

Marie Carmen Valenza, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor

Study Record Dates

First Submitted

May 17, 2014

First Posted

May 21, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations