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

COVID Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04403438
• Other study ID #: 10840098-604.01.01-E.14697
• Status: Enrolling by invitation
• Start date: April 1, 2020
• Est. completion date: June 15, 2020

Study information

• Verified date: May 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: June 15, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behcet Disease
• Behcet Syndrome
• Brucellosis
• COVID
• Familial Mediterranean Fever
• FMF
• Hereditary Autoinflammatory Diseases

Intervention

Other:
• it 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.
it 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.

Locations

Country	Name	City	State
Turkey	IstanbulU	Istanbul	Bakirköy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPAQ-SF	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.	one assesment baseline
Primary	Numeric Rating Scale	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	one assesment baseline
Secondary	Short-Form 36 Health Survey (SF-36)	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 Koçyigit 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.	one assesment baseline
Secondary	Exercise Stage of Change Questionnaire	it consists of five questions. The participant is asked to choose only one of these five situations that match the current exercise level.	one assesment baseline
Secondary	Exercise Self-Efficacy Questionnaire	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.	one assesment baseline
Secondary	Decisional Balance Questionnaire	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.	one assesment baseline