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Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04403438
Recruitment Status : Enrolling by invitation
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nejla Uzun, Istanbul University

Brief Summary:
Behcet' disease (BD) is a chronic inflammatory disease which is characterized by oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthrits, arthralgia, enthesis and sacroiliitis can be seen in course of BD. FMF is an autosomal recessive family disease characterized by abdominal pain, chest pain, joint pain and fever attacks as a result of inflammation of the serous membranes. FMF patients have been shown to experience higher levels of pain, fatigue, depression and anxiety than healthy controls, and this has increased sleep disturbance and reduced quality of life. FMF and BiH have common characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. In December 2019, after the officially detected coronavirus (severe acute respiratory syndrome coranavirus-2 [SARS-CoV-2]) resistant to unknown treatment and rapidly spreading coronavirus in our country on March 11, 2020 in Hubei province of China, the number of cases increased rapidly and virus was isolated in 670 patients within 10 days. Ongoing concerns about the spread of Covid-19 infections have caused many measures to be taken. Among them, social isolation, home quarantine and avoiding collective places are the most important. In our country, in the process of social isolation, the areas of movement of Behçet and FMF patients, like everyone else, were restricted, their stress and anxiety levels increased and their motivation decreased. The aim of our study is to compare the pain, sleep, fatigue, physical activity level and quality of life and question exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.

Condition or disease Intervention/treatment
Behcet Disease COVID FMF Other: ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain, Sleep, Fatigue, Physical Activity Level, Quality of Life and Exercise Habits in Patients With Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 15, 2020


Group/Cohort Intervention/treatment
patients with behçet's or fmf Other: ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.
ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.




Primary Outcome Measures :
  1. IPAQ-SF [ Time Frame: one assesment baseline ]
    The Turkish validity and reliability study of this short questionnaire consisting of seven questions, which evaluates in detail the amount of walking performed in the last week and the amount of moderate and difficult physical activity performed in work, transportation, housework, gardening and leisure activities.

  2. Numeric Rating Scale [ Time Frame: one assesment baseline ]
    It has horizontal and vertical forms. In this scale, the starting point is the point where there is no pain, and the ending point is the end point where the pain is worst


Secondary Outcome Measures :
  1. Short-Form 36 Health Survey (SF-36) [ Time Frame: one assesment baseline ]
    It is a scale which was found by Ware in 1987 and examined the quality of life of people. Turkish validity was provided in the study of Koçyiğit et al. The scale consisting of 36 questions was divided into its own subtitles and was made to measure the functional status of the person.

  2. Exercise Stage of Change Questionnaire [ Time Frame: one assesment baseline ]
    it consists of five questions. The participant is asked to choose only one of these five situations that match the current exercise level.

  3. Exercise Self-Efficacy Questionnaire [ Time Frame: one assesment baseline ]
    This six-point five-point Likert-type scale determines the self-confidence of individuals to begin exercise. The lowest 6 and the highest 30 points are obtained from the scale. The high scores obtained from the scale indicate that the individual trusts him / herself and has a high chance of success in change.

  4. Decisional Balance Questionnaire [ Time Frame: one assesment baseline ]
    Items 2, 4, 6, 8, 10 on a scale consisting of a total of 10 items are expressions designed to evaluate the perceived harm of not exercising, items 1, 3, 5, 7, and 9 are intended to evaluate the perceived benefits of exercising.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In patients with Behçet and FMF between the ages of 18-65, exercise habits will be questioned by comparing pain, sleep, fatigue, physical activity level and quality of life before and after the covid-19 outbreak.
Criteria

Inclusion Criteria:

  • Being between the ages of 18-65
  • Being diagnosed with FMF at least 1 year ago according to diagnostic criteria
  • A diagnosis of BiH at least 1 year ago according to the International Behçet Working Group
  • Having signed the informed consent form
  • Having a cooperative level that will respond to evaluation scales

Exclusion Criteria:

  • Pregnant women
  • Having other chronic diseases
  • Psychiatric disorders and treated
  • Those with cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403438


Locations
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Turkey
IstanbulU
Istanbul, Bakırköy, Turkey, 34740
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: nejla uzun, MSc, Pt Istanbul University-Cerrahpasa
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Responsible Party: Nejla Uzun, MSc, Pt, Istanbul University
ClinicalTrials.gov Identifier: NCT04403438    
Other Study ID Numbers: 10840098-604.01.01-E.14697
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brucellosis
Behcet Syndrome
Familial Mediterranean Fever
Hereditary Autoinflammatory Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Gram-Negative Bacterial Infections
Bacterial Infections