Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Rheumatoid Arthritis Patients

NCT05957770 | Completed DMC

• 1 other identifier: 04-2023-300223
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in rheumatoid arthritis patients The main aims are:

• asses anxiety, sleep, depression and quality of life in rheumatoid arthritis patients
• their relation to disease activity we will compare rheumatoid arthritis patients to healthy subjects.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• Evaluation of insomnia in RA patients by Insomnia severity index

  insomnia severity index contains seven domains assessing sleep-onset difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning, impairment attributed to sleep problems, and distress associated with insomnia. Each item is rated on a 0-4 scale, and th e total score ranges from 0 to 28. A higher score suggests more severe insomnia

  1 month

• evaluation of excessive daytime sleepiness by Epworth sleepiness scale

  Subjects describe how often they fall asleep in certain situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10 is indicative of subjective excessive daytime sleepiness and score \> 16 indicates high level of daytime sleepiness

  1 month

• evaluation of anxiety in RA patients by hamilton anxiety scale

  It consists of 14 items and measures both psychic and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score ≤ 17 indicates mild anxiety, 18-24 mild to moderate anxiety, , 25-30 moderate to severe anxiety and scores \>30 indicate severe anxiety

  1 month

• evaluation of depression in RA patients by hamilton depression scale

  The original scale has 21 items, but scoring is based only on the first 17 with total score ranges from 0 to 52. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and \> 22 very severe depression

  1 month

• evaluation of QoL in RA patients by short form health survey (sf36 )

  Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Mean score ranges from 0 to100. High scores indicate lower disability.

  1 month

• evaluation of sleep quality and disturbances in RA patients by Pittsburgh Sleep Quality Index

  The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score \> 5 suggests poor sleep quality

  1 month

Secondary Outcomes (1)

• Correlation of disease activity( das28) with hamilton anxiety scale, hamilton depression scale,Epworth sleepiness scale,Pittsburgh Sleep Quality Index and short form health survey sf 36

  1 month

Study Arms (2)

cases

rheumatoid arthritis patients

control

healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with RA according to 2010 the American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria. Healthy subjects

You may qualify if:

• Patients diagnosed with RA according to 2010 the American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria

You may not qualify if:

• Evidence of end-organ failures such as heart failure, a liver cell or renal failure,
• History of psychological disorders or medications.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine, Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maha Abdelrahman, MD,PhD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 24, 2023
• Study Start: February 1, 2023
• Primary Completion: October 15, 2023
• Study Completion: October 30, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

EG (1)