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Trial record 1 of 1 for:    NCT04143100
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Anxiety and Symptom Burden in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT04143100
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
The Rogosin Institute

Brief Summary:

Anxiety has been identified as a prevalent and significant co-morbid condition in patients with End Stage Renal Disease (ESRD) being treated with hemodialysis. In particular, anxious sensitivity to symptoms commonly experienced by dialysis patients may lead patients to prematurely terminate their dialysis sessions and may have consequences on their dialysis adequacy and overall quality of life.

The proposed study will examine the relationships between anxiety, depression, quality of life, symptom burden and dialysis prescription adherence. The primary regression analyses will be used to predict the influence of anxiety and depression (independently and together) on measures of adherence behaviors.


Condition or disease Intervention/treatment
Anxiety ESRD Other: Survey

Detailed Description:
Additional analyses will examine the relationship of elevated anxiety and depression scores on symptom burden, QOL, and other measures of dialysis adherence. Retrospective data of the preceding three months will be used to calculate measures of dialysis adherence (shortening and skipping) and clinical parameters.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Anxiety, Symptom Burden, and Dialysis Adherence in In-center Hemodialysis Patients
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Dialysis


Intervention Details:
  • Other: Survey
    For our primary analysis (multiple regression) scores on the GAD-7, BAI and PHQ-9 will be used to predict dialysis adherence, as defined as minutes reduced (total dialysis prescribed -total actual time on machine) while controlling for age and gender.


Primary Outcome Measures :
  1. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: This is a cross-sectional study, with anxiety scores being correlated with previous 6 months of adherence data ]
    Anxiety measure - higher scores indicate more anxiety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving treatment at The Rogosin Institute (Rogosin) hemodialysis treatment facilities.
Criteria

Inclusion Criteria:

  • Receiving In-center hemodialysis

Exclusion Criteria:

  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143100


Contacts
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Contact: Daniel Cukor, PhD 646-317-0798 dac9227@nyp.org

Locations
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United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Daniel Cukor, Ph.D.    646-317-0798    dac9227@nyp.org   
Principal Investigator: Daniel Cukor, Ph.D.         
Sponsors and Collaborators
The Rogosin Institute
Investigators
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Principal Investigator: Daniel Cukor, PhD The Rogosin Institute
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Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT04143100    
Other Study ID Numbers: 19-06020314
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders