Anxiety and Symptom Burden in Hemodialysis Patients

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.

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Key information

Conditions

Anxiety Anxiety Disorders Chronic Disease Disease Attributes ESRD Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Rogosin Institute

New York, 10021, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Receiving In-center hemodialysis

Exclusion criteria

Non-English speaking

Treatment and study plan

Survey

Other

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 outcomes

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

Sponsors and collaborators

Lead sponsor

The Rogosin Institute

Other

Registry information

Official study title

Anxiety, Symptom Burden, and Dialysis Adherence in In-center Hemodialysis Patients

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Oct 29, 2019
Registry last updated: Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed