Comparison of Dialysis Therapies on Cognitive Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Satellite Healthcare.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Satellite Healthcare
ClinicalTrials.gov Identifier:
NCT00597103
First received: January 8, 2008
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

This study will evaluate the effects of more frequent dialysis on cognitive function including the assessment of sleep apnea and restless legs. Our hypothesis is that more frequent dialysis improves cognitive function and may have important implications on clinical care of ESRD patients and help to emphasize the need for treatments that will allow patients to live "with dialysis" rather than live "for dialysis".


Condition Intervention
End Stage Renal Disease
Chronic Kidney Disease
Other: Cognitive Function Testing-10 Tests
Other: Sleep Assessment Testing
Other: Periodic Leg Movement Syndrome Assessment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Dialysis Therapies on Cognitive Function

Resource links provided by NLM:


Further study details as provided by Satellite Healthcare:

Primary Outcome Measures:
  • Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis [ Time Frame: baseline, 4 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Longitudinal analysis of cognitive function over time to test the hypothesis that more frequent hemodialysis contributes to delay in cognitive function impairment [ Time Frame: baseline, 4 months and 12 months ] [ Designated as safety issue: No ]
  • To test the hypothesis that nightly or daily hemodialysis treatment can ultimately be proven to be cost effective options by preserving cognitive function. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Influence of cognitive function on survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Prevalent patients who have been receiving more frequent dialysis.
Other: Cognitive Function Testing-10 Tests
Trailmaking A, Trailmaking B, Rey Auditory Verbal Learning, Letter Number Sequencing, Digit Symbol Substitution, Grooved Pegboard, Controlled Oral Word Association, Beck Depression Index, Feeling Thermometer, Modified Mini-Mental Status
Other: Sleep Assessment Testing
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
Other: Periodic Leg Movement Syndrome Assessment
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.
2
Incident patients new to more frequent dialysis
Other: Cognitive Function Testing-10 Tests
Trailmaking A, Trailmaking B, Rey Auditory Verbal Learning, Letter Number Sequencing, Digit Symbol Substitution, Grooved Pegboard, Controlled Oral Word Association, Beck Depression Index, Feeling Thermometer, Modified Mini-Mental Status
Other: Sleep Assessment Testing
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
Other: Periodic Leg Movement Syndrome Assessment
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.
3
Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen.
Other: Cognitive Function Testing-10 Tests
Trailmaking A, Trailmaking B, Rey Auditory Verbal Learning, Letter Number Sequencing, Digit Symbol Substitution, Grooved Pegboard, Controlled Oral Word Association, Beck Depression Index, Feeling Thermometer, Modified Mini-Mental Status
Other: Sleep Assessment Testing
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
Other: Periodic Leg Movement Syndrome Assessment
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis.

Criteria

Inclusion Criteria:

  • Diagnosis of ESRD
  • Age 18 years or greater
  • Ability to understand and a willingness to sign an informed consent statement and a Health Insurance Portability and Accountability Act of 1996 (HIPPA) authorization statement.
  • Expected survival of at least one year.

Exclusion Criteria:

  • Documented non-compliance, defined as missing more than 10% of prescribed treatments during the month prior to the start of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597103

Contacts
Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com
Contact: Sheila Doss, RN, CNN, CCRA 650-404-3621 dosss@satellitehealth.com

Locations
United States, California
Satellite Healthcare, Inc Recruiting
Mountain View, California, United States, 94041
Contact: Brigitte Schiller-Moran, MD    650-404-3640    schillerb@satellitehealth.com   
Contact: Sheila Doss, RN, CNN, CCRA    650-404-3621    dosss@satellitehealth.com   
Principal Investigator: Brigitte Schiller-Moran, MD         
WellBound, Inc. Recruiting
Mountain View, California, United States, 94041
Contact: Brigitte Schiller-Moran, MD    650-404-3640    schillerb@satellitehealth.com   
Contact: Sheila Doss, RN, CNN, CCRA    650-404-3621    dosss@satellitehealth.com   
Principal Investigator: Brigitte Schiller-Moran, MD         
Sponsors and Collaborators
Satellite Healthcare
Investigators
Principal Investigator: Brigitte Schiller-Moran, MD Satellite Healthcare, Inc.
  More Information

No publications provided

Responsible Party: Brigitte Schiller-Moran MD, Satellite Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT00597103     History of Changes
Other Study ID Numbers: SR016CF
Study First Received: January 8, 2008
Last Updated: January 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Satellite Healthcare:
Hemodialysis
Frequent Hemodialysis
Sleep Apnea
Restless Leg Syndrome
Cognitive Function

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 28, 2014