NCT06844890

Brief Summary

Depression is frequently seen among hemodialysis patients; however, it causes an impaired quality of life, a decrease in adherence to treatment, and an increase in hospitalization and mortality rate. It has been stated in the literature that the prevalence rate of depression in hemodialysis patients varies between 25-73%. Despite its high prevalence rate and adverse effects, it has been revealed that only a low rate of patients with depressive symptoms are diagnosed and treated. This is primarily associated with the fact that depressive symptoms in patients are not adequately recognized and examined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 20, 2025

Last Update Submit

February 26, 2025

Conditions

Keywords

depressiondialysismanagement

Outcome Measures

Primary Outcomes (1)

  • Predict of depression risk with questionnare

    Depression Inventory for Maintenance Hemodialysis Patients The inventory, developed by the researchers consists of 17 items. In this four-point likert type scale; items are rated as never: 1 point, sometimes: 2 points, often: 3 points, and almost always: 4 points. Minimum and maximum scores of the inventory are 17 points and 68 points, respectively. Higher scores indicate that severity of fatigue increases. A score of 25 or more from the inventory indicates the presence of depression. At this cut-off point, the sensitivity and specificity of the inventory are 97% and 86%. The Cronbach's alpha value of the inventory is 0.893. The inventory has four subscales; low mood subscale: 7 items (7-28 points), inhibition of movement and thought subscale: 4 items (4-16 points), change in cognition subscale: 4 items (4-16 points), low self-evaluation subscale: 2 items (2-8 points). Higher scores mean that the situation reflected by the subscale worsens.

    Up to 15 days

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Taking hemodialysis therapy in dialysis unit

You may qualify if:

  • Patients aged 18 years and older
  • Patients who were receiving hemodialysis treatment for at least three months
  • Patients could communicate in Turkish
  • Patients who agreed to participate in the study were included in the study.

You may not qualify if:

  • Patients who suffered from psychiatric disorders such as chronic psychosis and were previously diagnosed with depression were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nurten Ozen

Istanbul, 34116, Turkey (Türkiye)

Location

Related Publications (2)

  • Wang YY, Zhang WW, Feng L, Gao D, Liu C, Zhong L, Ren JW, Wu YZ, Huang L, Fu LL, He YN. Development and Preliminary Validation of a Depression Assessment Tool for Maintenance Hemodialysis Patients. Ther Apher Dial. 2019 Feb;23(1):49-58. doi: 10.1111/1744-9987.12749. Epub 2018 Sep 21.

    PMID: 30239119BACKGROUND
  • Palmer S, Vecchio M, Craig JC, Tonelli M, Johnson DW, Nicolucci A, Pellegrini F, Saglimbene V, Logroscino G, Fishbane S, Strippoli GF. Prevalence of depression in chronic kidney disease: systematic review and meta-analysis of observational studies. Kidney Int. 2013 Jul;84(1):179-91. doi: 10.1038/ki.2013.77. Epub 2013 Mar 13.

MeSH Terms

Conditions

DepressionRisk-Taking

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Nurten Ozen, Assoc. Prof.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

April 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations