DepressionCOST-HDNCT04444557
Effect of COvid-19 on Mental Health in Syrian and Turkish Maintenance HemoDialysis Patients: COST-HD Study
An observational study of Depression and Hemodialysis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Hemodialysis
- What is being tested?
- Beck Depression Inventory (BDI)
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2020to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Patients older than 18 years old
- Hemodialysis history of more than three months
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
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.
- Conditions
- Depression, Hemodialysis
- Being tested
- Beck Depression Inventory (BDI)
- Keywords
- hemodialysis, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beck Depression Inventory (BDI)Other
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
| Study group | Role | What they receive |
|---|---|---|
| Turkish hemodialysis patients | Turkish patients undergoing in-center hemodialysis Receives: Other: Beck Depression Inventory (BDI) | |
| Temporarily protected Syrian hemodialysis patients | Temporarily protected Syrian patients undergoing in-center hemodialysis Receives: Other: Beck Depression Inventory (BDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Beck Depression Inventory
Total score of Beck Depression Inventory (Minimin score: 0, Maximum score: 63; higher scores mean worse outcome)
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start17 Apr 2020
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuri Baris Hasbal, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Mustafa Sevinc, MD, Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444557
- Sponsor's protocol ID
- 200620
- Acronym
- COST-HD
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If requested, IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COvid-19 on Mental Health in Syrian and Turkish Maintenance HemoDialysis Patients: COST-HD Study
- ClinicalTrials.gov ID
- NCT04444557
- Acronym / sponsor ID
- COST-HD / 200620
- Conditions
- Depression, Hemodialysis
- Keywords
- hemodialysis, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turkish hemodialysis patients | – | Other: Beck Depression Inventory (BDI)Turkish patients undergoing in-center hemodialysis |
| Temporarily protected Syrian hemodialysis patients | – | Other: Beck Depression Inventory (BDI)Temporarily protected Syrian patients undergoing in-center hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Patients older than 18 years old
- Hemodialysis history of more than three months
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beck Depression Inventory (BDI)The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression | Other | Temporarily protected Syrian hemodialysis patients, Turkish hemodialysis patients |
Primary outcome
Score of Beck Depression Inventory
Time frame: through study completion, an average of 6 months
Total score of Beck Depression Inventory (Minimin score: 0, Maximum score: 63; higher scores mean worse outcome)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: Undecided. If requested, IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Sevinc, MD principal investigator
Sisli Hamidiye Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Hemodialysis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Beck Depression Inventory (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.