NCT04444557

Brief Summary

SARS-COV infection first has begun at Wuhan, China, and then became a pandemic. The first COVID-19 case has been reported on March 11, 2020, in Turkey. People older than 65 years old have been locked down on March 21 and people younger than 20 years old locked down at April 03. A total lockdown has been done a few times lasting for 3 or 4 days, especially at weekends. Renal replacement modalities have been affected in different ways during the pandemic. Patients with kidney transplantation and patients performing home hemodialysis or peritoneal dialysis have been advised to perform self-isolation at homes. However, center hemodialysis patients continued to come dialysis centers obligatorily. Syrian civil war has been continuing since 2011, and Turkey has accepted millions of Syrian people in a position called temporary protection. There are many Syrian center hemodialysis patients both in Turkey and in our unit. The investigators do not know if pandemic affected Syrian patients different than Turkish ones. The aim of this study is to compare beck depression scores of Turkish and Syrian patients undergoing hemodialysis during the COVID-19 pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

14 days

First QC Date

June 21, 2020

Last Update Submit

June 22, 2020

Conditions

Keywords

hemodialysisdepression

Outcome Measures

Primary Outcomes (1)

  • Score of Beck Depression Inventory

    Total score of Beck Depression Inventory (Minimin score: 0, Maximum score: 63; higher scores mean worse outcome)

    through study completion, an average of 6 months

Study Arms (2)

Turkish hemodialysis patients

Turkish patients undergoing in-center hemodialysis

Other: Beck Depression Inventory (BDI)

Temporarily protected Syrian hemodialysis patients

Temporarily protected Syrian patients undergoing in-center hemodialysis

Other: Beck Depression Inventory (BDI)

Interventions

The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression

Temporarily protected Syrian hemodialysis patientsTurkish hemodialysis patients

Eligibility Criteria

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

All patients undergoing in-center hemodialysis in Sisli Hamidiye Etfal Training and Research hospital (22 patients excluded from the study in accordance with exclusion criteria)

You may qualify if:

  • Patients older than 18 years old
  • Hemodialysis history of more than three months

You may not qualify if:

  • Patients who can not speak Turkish or Arabic,
  • Not volunteer to fill the form
  • History of hospitalization for any reason during the pandemic time,
  • History of COVID-19 before the questionnaire (Beck Depression Inventory)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Mustafa Sevinc, MD

    Sisli Hamidiye Etfal Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 23, 2020

Study Start

April 17, 2020

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations