Anxiety and Symptom Burden in Hemodialysis Patients

NCT ID: NCT04143100

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Anxiety ESRD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Receiving In-center hemodialysis

Exclusion Criteria

* Non-English speaking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Rogosin Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Cukor, PhD

Role: PRINCIPAL_INVESTIGATOR

The Rogosin Institute

Locations

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The Rogosin Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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19-06020314

Identifier Type: -

Identifier Source: org_study_id

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