The Cohort Study of Cognitive Impairment in Chinese Hemodialysis Patients (CODE)

July 11, 2019 updated by: Yang Luo, Chief, MD, PhD, Beijing Shijitan Hospital, Capital Medical University

The Cohort Study of Cognitive Impairment and Its Association With Clinical Outcomes in Chinese Maintenance Hemodialysis Patients

This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains in our cohort of 600 maintenance hemodialysis patients and evaluate:

  1. The presence and patterns of cognitive impairment in domains of executive function, perceptual-motor function, language, learning and memory, and complex attention;
  2. Clinical characteristics of participants with and without cognitive impairment;
  3. the risk factors which might be related to cognitive impairment in this group of population;
  4. The association between cognitive impairment and all-cause mortality, stroke and non-fatal cardiovascular events;

We hypothesize that hemodialysis patient is going to have cognitive impairment which might be associated with some risk factors. We also anticipate that cognitive impairment might have some kind of association with the clinical outcomes like all-cause mortality, stroke and other common clinical outcomes that we mentioned above.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neuropsychological assessment All neuropsychological assessments were performed by the research staff that was centrally trained and certified by the study neuropsychologist to conduct the assessments before study commencement. All research staff and patients were native Chinese speakers. Neuropsychological assessment was conducted individually in a separate room on the day after a dialysis session and required on average approximately 90 minutes. Global cognitive function was screened by the Chinese Beijing version of the Montreal Cognitive Assessment (MoCA-BJ).10 The comprehensive battery of neuropsychological tests was designed to assess five cognitive domains: (1) attention/processing speed, using Symbol Digit Modalities Test and the Chinese modified version of the Trail Making Test A,11,12(2) executive function, using the Chinese modified version of the Trail Making Tests B , and a modified version of the Stroop Color-Word Test;13 (3) verbal memory, using the Chinese version of the Auditory Verbal Learning Test for short-delay and long-delay free recall14 and Complex Figure for visual memory (delayed recall test; Chinese version);12 (4) language, using the Chinese modified versions of Boston Naming Test (the 30-item version) and Animal Fluency Test;15,16and (5) visuospatial function, using the Rey-Osterrieth Complex Figure (copy test).17,18 Depression was assessed using the Hamilton Depression Scale, with scores ranging from 0 to 63 and a score of 7 or above suggested as the optimal cutoff for suspected depression.

Study Type

Observational

Enrollment (Actual)

613

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100038
        • Beijing Shijitan Hospital Affiliated to Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese Maintenace Hemodialysis Patients

Description

Inclusion Criteria:

  1. Subjects have end-stage kidney disease and are treated with long-term outpatient haemodialysis in each investigational site for at least the previous 3 months;
  2. 50 ~ 80 years old;
  3. willing to provide written and informed consent.

Exclusion Criteria:

  1. Subjects have disturbance of consciousness or mental disorder;
  2. Subjects have sensory (visual and hearing) or motor impairment, which disabled them to complete the tests that required these senses;
  3. Subjects have a life expectancy less than 6 months according to their physician, have a planned kidney transplantation within 6 months of baseline, or have anticipated recovery of kidney function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal cognitive function
The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively
cognitive impairment
The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively
Other: cognitive impairment
one are of patients were exposed to cognitive impairment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: This measurement is going to be completed within 3 months after the first participant enrolls.
This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains
This measurement is going to be completed within 3 months after the first participant enrolls.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Shijitan Hospital, Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

June 18, 2019

Study Completion (Actual)

June 18, 2019

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z161100002616005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Impairment

Clinical Trials on cognitive impairment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe