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出境医 / 临床实验 / Subjective Ageing in Fibromyalgia

Subjective Ageing in Fibromyalgia

Study Description
Brief Summary:
Subjective age or felt age is the term used for how the person feels; one can feel same, younger or older than their actual age. Feeling younger or feeling older may be associated with depression, anxiety, fatigue, sleep, quality of life or cognitive function.

Condition or disease
Fibromyalgia

Detailed Description:
In this cross-sectional study, the investigators hypothesized that fibromyalgia patients mostly feel older than their actual age and this felt age may be associated with depression, anxiety, fatigue, sleep, quality of life or cognition. After power analysis, study sample calculated as 262 patients, the present study will use 2016 revised American College of Rheumatology criteria to diagnose fibromyalgia.
Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 262 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Subjective Ageing in Fibromyalgia: Why Fibromyalgia Patients Feel Old?
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : January 27, 2020
Actual Study Completion Date : January 27, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Subjective age [ Time Frame: Four months ]
    The study will ask the patient: " how old do you feel?". Subjective age will calculate as Subjective age extracted from actual age. If the result is positive, the patient feel younger, if visa versa the patient feels older

  2. Depression [ Time Frame: Four months ]
    The status of depression will calculate using Beck Depression Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher depression levels of the patient.

  3. Anxiety [ Time Frame: Four months ]
    The status of anxiety will calculate using Beck Anxiety Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher anxiety levels of the patient. The total score is calculated by finding the sum of the 21 items. Each question scored 0 to 3 points. Score of 0-21 = low anxiety,score of 22-35 = moderate anxiety, score of 36 and above = potentially concerning levels of anxiety

  4. Sleep [ Time Frame: Four months ]
    The status of sleep quality of the patients will calculate using Pittsburgh Sleep Quality Index. The index is a self- scored 24 item questionnaire and 7 subgroups. Higher scores show bad sleep quality and lower scores indicate good sleep quailty.

  5. Fatigue [ Time Frame: Four months ]
    The fatigue levels of the patients will be determined using The Fatigue Severity Scale. This scale self-reported 9 item questionnaire, each question scored between 0-7, total score divided to nine and if the result <2.8, no fatigue and if > 6.1, chronic fatigue syndrome diagnosis can be made. Higher score shows higher probability of chronic fatigue syndrome.

  6. Cognitive Function [ Time Frame: Four months ]
    The cognition status of the patients will be determined using Mini-mental State Examination. This test includes five subscales, scoreing 0 - 30 points. Lower scores show poorer cognitive function

  7. Life Quailty [ Time Frame: Four months ]
    The quality of life of the patients will be determined using Short-form 36. The self-reported questionnaire includes 11 subscales. Higher scores show poorer quality of life.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
262 patients diagnosed with fibromyalgia will be included in the study
Criteria

Inclusion Criteria:

  • Fibromyalgia diagnosis using 2016 revised American College of Rheumatology
  • aged >18 years old
  • Widespread pain more than 3 months

Exclusion Criteria:

  • Any disease that can cause depression, anxiety, fatigue, poor sleep quality or poor cognitive function except from fibromyalgia.
Contacts and Locations

Locations
Layout table for location information
Turkey
Mehmet Akif Guler
İstanbul, İ̇stanbul, Turkey, 34104
Sponsors and Collaborators
Gaziosmanpasa Research and Education Hospital
Tracking Information
First Submitted Date May 22, 2019
First Posted Date May 29, 2019
Last Update Posted Date January 28, 2020
Actual Study Start Date June 1, 2019
Actual Primary Completion Date January 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2019)
  • Subjective age [ Time Frame: Four months ]
    The study will ask the patient: " how old do you feel?". Subjective age will calculate as Subjective age extracted from actual age. If the result is positive, the patient feel younger, if visa versa the patient feels older
  • Depression [ Time Frame: Four months ]
    The status of depression will calculate using Beck Depression Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher depression levels of the patient.
  • Anxiety [ Time Frame: Four months ]
    The status of anxiety will calculate using Beck Anxiety Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher anxiety levels of the patient. The total score is calculated by finding the sum of the 21 items. Each question scored 0 to 3 points. Score of 0-21 = low anxiety,score of 22-35 = moderate anxiety, score of 36 and above = potentially concerning levels of anxiety
  • Sleep [ Time Frame: Four months ]
    The status of sleep quality of the patients will calculate using Pittsburgh Sleep Quality Index. The index is a self- scored 24 item questionnaire and 7 subgroups. Higher scores show bad sleep quality and lower scores indicate good sleep quailty.
  • Fatigue [ Time Frame: Four months ]
    The fatigue levels of the patients will be determined using The Fatigue Severity Scale. This scale self-reported 9 item questionnaire, each question scored between 0-7, total score divided to nine and if the result <2.8, no fatigue and if > 6.1, chronic fatigue syndrome diagnosis can be made. Higher score shows higher probability of chronic fatigue syndrome.
  • Cognitive Function [ Time Frame: Four months ]
    The cognition status of the patients will be determined using Mini-mental State Examination. This test includes five subscales, scoreing 0 - 30 points. Lower scores show poorer cognitive function
  • Life Quailty [ Time Frame: Four months ]
    The quality of life of the patients will be determined using Short-form 36. The self-reported questionnaire includes 11 subscales. Higher scores show poorer quality of life.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Subjective Ageing in Fibromyalgia
Official Title Subjective Ageing in Fibromyalgia: Why Fibromyalgia Patients Feel Old?
Brief Summary Subjective age or felt age is the term used for how the person feels; one can feel same, younger or older than their actual age. Feeling younger or feeling older may be associated with depression, anxiety, fatigue, sleep, quality of life or cognitive function.
Detailed Description In this cross-sectional study, the investigators hypothesized that fibromyalgia patients mostly feel older than their actual age and this felt age may be associated with depression, anxiety, fatigue, sleep, quality of life or cognition. After power analysis, study sample calculated as 262 patients, the present study will use 2016 revised American College of Rheumatology criteria to diagnose fibromyalgia.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 262 patients diagnosed with fibromyalgia will be included in the study
Condition Fibromyalgia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 24, 2019) 		262
Original Estimated Enrollment Same as current
Actual Study Completion Date January 27, 2020
Actual Primary Completion Date January 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Fibromyalgia diagnosis using 2016 revised American College of Rheumatology
  • aged >18 years old
  • Widespread pain more than 3 months

Exclusion Criteria:

  • Any disease that can cause depression, anxiety, fatigue, poor sleep quality or poor cognitive function except from fibromyalgia.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03966820
Other Study ID Numbers GaziosmanpasaTREH3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
Study Sponsor Gaziosmanpasa Research and Education Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Gaziosmanpasa Research and Education Hospital
Verification Date January 2020

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