NCT03966820

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

May 22, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

May 22, 2019

Last Update Submit

January 27, 2020

Conditions

Fibromyalgia

Keywords

AnxietyCognitive ageingDepressionFatigueFibromyalgiaQuality of lifeSleep

Outcome Measures

Primary Outcomes (7)

  • Subjective age

    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

    Four months

  • Depression

    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.

    Four months

  • Anxiety

    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

    Four months

  • Sleep

    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.

    Four months

  • Fatigue

    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.

    Four months

  • Cognitive Function

    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

    Four months

  • Life Quailty

    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.

    Four months

Eligibility Criteria

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

262 patients diagnosed with fibromyalgia will be included in the study

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Akif Guler

Istanbul, İ̇stanbul, 34104, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaAnxiety DisordersDepressionFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesMental DisordersBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 29, 2019

Study Start

June 1, 2019

Primary Completion

January 27, 2020

Study Completion

January 27, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)