Anxiety and Symptom Burden in Hemodialysis Patients

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143100
• Other study ID #: 19-06020314
• Status: Completed
• Start date: August 30, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2022
• Source: The Rogosin Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Receiving In-center hemodialysis

Exclusion Criteria:

• Non-English speaking

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• 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.

Locations

Country	Name	City	State
United States	The Rogosin Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Rogosin Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generalized Anxiety Disorder-7 (GAD-7)	Anxiety measure - higher scores indicate more anxiety	This is a cross-sectional study, with anxiety scores being correlated with previous 6 months of adherence data