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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 : Active, not recruiting
First Posted : October 29, 2019
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
The Rogosin Institute

Tracking Information
First Submitted Date October 24, 2019
First Posted Date October 29, 2019
Last Update Posted Date September 28, 2021
Actual Study Start Date August 30, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anxiety and Symptom Burden in Hemodialysis Patients
Official Title Anxiety, Symptom Burden, and Dialysis Adherence in In-center Hemodialysis Patients
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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients receiving treatment at The Rogosin Institute (Rogosin) hemodialysis treatment facilities.
Condition
  • Anxiety
  • ESRD
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 25, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Receiving In-center hemodialysis

Exclusion Criteria:

  • Non-English speaking
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04143100
Other Study ID Numbers 19-06020314
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party The Rogosin Institute
Study Sponsor The Rogosin Institute
Collaborators Not Provided
Investigators
Principal Investigator: Daniel Cukor, PhD The Rogosin Institute
PRS Account The Rogosin Institute
Verification Date September 2021