Rheumatoid ArthritisNCT04278170
Sleep Quality in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to investigate the factors affecting sleep quality of Rheumatoid arthritis patients in Turkish population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- no attempt was made to patients
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2014to 15 Oct 2018
- How long will I take part?
- 1 Day
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Rheumatoid arthritis patients
Who may be able to join
- patients with RA who met the 2010 American College of Rheumatology (ACR) RA classification criteria were included
Who cannot join
- Patients who had difficulties understanding and responding to questions were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, 34186
About this study
Official title: An Investigation of Factors Affecting Sleep Quality in Patients With Rheumatoid Arthritis
This study was designed to investigate the factors affecting sleep quality of Rheumatoid arthritis patients in Turkish population.
Read the detailed description
Demographic data, duration of disease, routine biochemical tests and currently used medications were recorded. Disease activity was assessed with Disease Activity Score 28 (DAS 28). Visual Analog Scale (VAS) was used to evaluate pain levels. Health Assessment Questionnaire (HAQ) was used to assess activities of daily living. Beck depression inventory (BDI) was used to investigate the signs of depression in patients. Sleep quality was considered to be poor in patients with a Pittsburgh Sleep Quality Index (PSQI) global score of 5 and greater.
- Conditions
- Rheumatoid Arthritis
- Being tested
- no attempt was made to patients
- Keywords
- sleeping disorders, sleep quality
- Medical subject headings
- Arthritis, Rheumatoid, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no attempt was made to patientsOther
no attempt was made to patients
| Study group | Role | What they receive |
|---|---|---|
| Case group | Rheumatoid arthritis patients who met the American College of Rheumatology (ACR) 2010 RA classification Receives: Other: no attempt was made to patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The factor affecting sleep quality of Rheumatoid arthritis patients
Demographic data
Measured: 1 day
duration of disease
factor affecting sleep quality of Rheumatoid arthritis patients
Measured: 1 day
Sleep quality of Rheumatoid arthritis patients
Pittsburg Sleep Quality Index (PSQI) was used to evaluate the sleep quality of the patients. PSQI is a questionnaire which assesses sleep quality by questioning the patient on 7 main sections; i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep activity, sleep disorders, use of sleep medication and daytime dysfunctions. Questions are scored from 0 to 3, high scores reflecting poor sleep quality. Seven main components are first evaluated individually and then the scores are added. A total score of 5 and above indicates poor sleep quality
Measured: 1 day
Disease activity of Rheumatoid arthritis patients
Disease activity was assessed with Disease Activity Score 28 (DAS 28).
Measured: 1 day
The pain evaluating of Rheumatoid arthritis patients
Visual Analog Scale (VAS) was used to evaluate pain levels.
Measured: 1 day
General health of Rheumatoid arthritis patients
Health Assessment Questionnaire (HAQ) was used to assess activities of daily living.
Measured: 1 day
Depression of Rheumatoid arthritis patients
Beck depression inventory (BDI) was used to investigate the signs of depression in patients.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start15 May 2014
- Primary completion15 Jun 2015
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aysenur Bardak, MD, Study director, Istanbul Physical Therapy and Rehabilitation Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278170
- Sponsor's protocol ID
- TURKEYPMRTRH
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Szady P, Baczyk G, Kozlowska K. Fatigue and sleep quality in rheumatoid arthritis patients during hospital admission. Reumatologia. 2017;55(2):65-72. doi: 10.5114/reum.2017.67600. Epub 2017 Apr 28.
PubMed 28539677Purabdollah M, Lakdizaji S, Rahmani A, Hajalilu M, Ansarin K. Relationship between Sleep Disorders, Pain and Quality of Life in Patients with Rheumatoid Arthritis. J Caring Sci. 2015 Sep 1;4(3):233-41. doi: 10.15171/jcs.2015.024. eCollection 2015.
PubMed 26464840Goes ACJ, Reis LAB, Silva MBG, Kahlow BS, Skare TL. Rheumatoid arthritis and sleep quality. Rev Bras Reumatol Engl Ed. 2017 Jul-Aug;57(4):294-298. doi: 10.1016/j.rbre.2016.07.011. Epub 2016 Aug 12. English, Portuguese.
PubMed 28743355
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Factors Affecting Sleep Quality in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04278170
- Acronym / sponsor ID
- TURKEYPMRTRH
- Conditions
- Rheumatoid Arthritis
- Keywords
- sleeping disorders, sleep quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 15 May 2014 (actual)
- Primary completion
- 15 Jun 2015 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 20 Feb 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.
This study was designed to investigate the factors affecting sleep quality of Rheumatoid arthritis patients in Turkish population.
Detailed description
Demographic data, duration of disease, routine biochemical tests and currently used medications were recorded. Disease activity was assessed with Disease Activity Score 28 (DAS 28). Visual Analog Scale (VAS) was used to evaluate pain levels. Health Assessment Questionnaire (HAQ) was used to assess activities of daily living. Beck depression inventory (BDI) was used to investigate the signs of depression in patients. Sleep quality was considered to be poor in patients with a Pittsburgh Sleep Quality Index (PSQI) global score of 5 and greater.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: no attempt was made to patientsRheumatoid arthritis patients who met the American College of Rheumatology (ACR) 2010 RA classification |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients
Key inclusion criteria (1 listed)
- patients with RA who met the 2010 American College of Rheumatology (ACR) RA classification criteria were included
Key exclusion criteria (1 listed)
- Patients who had difficulties understanding and responding to questions were excluded from the study.
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 |
|---|---|---|
| no attempt was made to patientsno attempt was made to patients | Other | Case group |
Primary outcome
The factor affecting sleep quality of Rheumatoid arthritis patients
Time frame: 1 day
Demographic data
duration of disease
Time frame: 1 day
factor affecting sleep quality of Rheumatoid arthritis patients
Sleep quality of Rheumatoid arthritis patients
Time frame: 1 day
Pittsburg Sleep Quality Index (PSQI) was used to evaluate the sleep quality of the patients. PSQI is a questionnaire which assesses sleep quality by questioning the patient on 7 main sections; i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep activity, sleep disorders, use of sleep medication and daytime dysfunctions. Questions are scored from 0 to 3, high scores reflecting poor sleep quality. Seven main components are first evaluated individually and then the scores are added. A total score of 5 and above indicates poor sleep quality
Disease activity of Rheumatoid arthritis patients
Time frame: 1 day
Disease activity was assessed with Disease Activity Score 28 (DAS 28).
The pain evaluating of Rheumatoid arthritis patients
Time frame: 1 day
Visual Analog Scale (VAS) was used to evaluate pain levels.
General health of Rheumatoid arthritis patients
Time frame: 1 day
Health Assessment Questionnaire (HAQ) was used to assess activities of daily living.
Depression of Rheumatoid arthritis patients
Time frame: 1 day
Beck depression inventory (BDI) was used to investigate the signs of depression in patients.
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 20 Feb 2020.
- Background: PubMed 28539677Szady P, Baczyk G, Kozlowska K. Fatigue and sleep quality in rheumatoid arthritis patients during hospital admission. Reumatologia. 2017;55(2):65-72. doi: 10.5114/reum.2017.67600. Epub 2017 Apr 28.
- Background: PubMed 26464840Purabdollah M, Lakdizaji S, Rahmani A, Hajalilu M, Ansarin K. Relationship between Sleep Disorders, Pain and Quality of Life in Patients with Rheumatoid Arthritis. J Caring Sci. 2015 Sep 1;4(3):233-41. doi: 10.15171/jcs.2015.024. eCollection 2015.
- Background: PubMed 28743355Goes ACJ, Reis LAB, Silva MBG, Kahlow BS, Skare TL. Rheumatoid arthritis and sleep quality. Rev Bras Reumatol Engl Ed. 2017 Jul-Aug;57(4):294-298. doi: 10.1016/j.rbre.2016.07.011. Epub 2016 Aug 12. English, Portuguese.
- Individual participant dataSharing planned: Undecided
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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.
Aysenur Bardak, MD study director
Istanbul Physical Therapy and Rehabilitation Research and Training 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 Rheumatoid Arthritis, run by Istanbul Physical Medicine Rehabilitation 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 1 inclusion and 1 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 20 Feb 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?
The factor affecting sleep quality of Rheumatoid arthritis patients (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278170, which also lists 3 linked publications.
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 20 Feb 2020.