NCT04278170

Brief Summary

This study was designed to investigate the factors affecting sleep quality of Rheumatoid arthritis patients in Turkish population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Longer than P75 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

May 15, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2015

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

February 18, 2020

Last Update Submit

February 19, 2020

Conditions

Rheumatoid Arthritis

Keywords

sleeping disorderssleep quality

Outcome Measures

Primary Outcomes (7)

  • The factor affecting sleep quality of Rheumatoid arthritis patients

    Demographic data

    1 day

  • duration of disease

    factor affecting sleep quality of Rheumatoid arthritis patients

    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

    1 day

  • Disease activity of Rheumatoid arthritis patients

    Disease activity was assessed with Disease Activity Score 28 (DAS 28).

    1 day

  • The pain evaluating of Rheumatoid arthritis patients

    Visual Analog Scale (VAS) was used to evaluate pain levels.

    1 day

  • General health of Rheumatoid arthritis patients

    Health Assessment Questionnaire (HAQ) was used to assess activities of daily living.

    1 day

  • Depression of Rheumatoid arthritis patients

    Beck depression inventory (BDI) was used to investigate the signs of depression in patients.

    1 day

Study Arms (1)

Case group

Rheumatoid arthritis patients who met the American College of Rheumatology (ACR) 2010 RA classification

Other: no attempt was made to patients

Interventions

no attempt was made to patientsOTHER

no attempt was made to patients

Case group

Eligibility Criteria

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

Rheumatoid arthritis patients

You may qualify if:

  • patients with RA who met the 2010 American College of Rheumatology (ACR) RA classification criteria were included

You may not qualify if:

  • Patients who had difficulties understanding and responding to questions were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28539677BACKGROUND

  • Purabdollah 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.

    PMID: 26464840BACKGROUND

  • Goes 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.

    PMID: 28743355BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidParasomniasSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Aysenur Bardak, MD

    Istanbul Physical Therapy and Rehabilitation Research and Training Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

May 15, 2014

Primary Completion

June 15, 2015

Study Completion

October 15, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

TU(1)