Anxiety and Symptom Burden in Hemodialysis Patients | NCT04143100

Studies
Anxiety and Symptom Burden in Hemodialysis Patients

NCT04143100

Sponsor

The Rogosin Institute

Status

Completed

Last Update Posted

Mar 2, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Anxiety
ESRD

Interventions

Survey

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Oct 24, 2019

First Submission Date that Met QC Criteria

Oct 25, 2019

First Posted Date

Oct 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2022

Last Update Posted Date

Mar 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Receiving In-center hemodialysis

Exclusion Criteria:

Non-English speaking

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving treatment at The Rogosin Institute (Rogosin) hemodialysis treatment facilities.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Cukor, PhD	The Rogosin Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Rogosin Institute		New York	New York	10021	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D001523	Mental Disorders
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided