Anxiety and Symptom Burden in Hemodialysis Patients

Sponsor
The Rogosin Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04143100
Collaborator
(none)
100
1
16.1
6.2

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Actual 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 :
Aug 30, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Generalized Anxiety Disorder-7 (GAD-7) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Receiving In-center hemodialysis
Exclusion Criteria:
  • Non-English speaking

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Rogosin Institute New York New York United States 10021

Sponsors and Collaborators

  • The Rogosin Institute

Investigators

  • Principal Investigator: Daniel Cukor, PhD, The Rogosin Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT04143100
Other Study ID Numbers:
  • 19-06020314
First Posted:
Oct 29, 2019
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022