NCT06357793

Brief Summary

Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

April 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

April 5, 2024

Last Update Submit

May 29, 2024

Conditions

Keywords

fibromyalgiawork productivity and activity impairmentquality of life

Outcome Measures

Primary Outcomes (1)

  • Work Productivity and Activity of Fibromyalgia Patients' Relatives

    Work Productivity and Activity Impairment questionnaire

    1 day

Secondary Outcomes (1)

  • Quality of life Fibromyalgia Patients' Relatives

    1 day

Study Arms (2)

fibromyalgia

The revised 2016 American College of Rheumatology (ACR) FM diagnostic criteria going to be use to diagnose FM participants group. Their relatives will fill out the WPAI:GH Questionnaire and World Health Organization Quality of Life (WHOQOL).

control

Healthy participants' relatives will fill out the WPAI:GH Questionnaire and World Health Organization Quality of Life (WHOQOL).

Eligibility Criteria

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

The revised 2016 American College of Rheumatology (ACR) FM diagnostic criteria were used to diagnose FM. Our study group participants have to live with FM patients. Also they have to work in a full or part-time job.

You may qualify if:

  • Study Group:
  • Must live together with a patient diagnosed with FM 18-65 years old Must work in a full-time/part-time job
  • Control Group:
  • Must live with a healthy relative 18-65 years old Must work in a full-time/part-time job

You may not qualify if:

  • Must live alone Not having a full-time/part-time job

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Salaffi F, Di Carlo M, Farah S, Mariani C, Fulginei S, Martino GP, Sarzi-Puttini P. A cross-sectional research on female workers examining the loss of productivity caused by mild, moderate and severe fibromyalgia. Clin Exp Rheumatol. 2022 Jun;40(6):1151-1158. doi: 10.55563/clinexprheumatol/hut4ft. Epub 2022 Jun 8.

    PMID: 35699070BACKGROUND
  • Neumann L, Buskila D. Quality of life and physical functioning of relatives of fibromyalgia patients. Semin Arthritis Rheum. 1997 Jun;26(6):834-9. doi: 10.1016/s0049-0172(97)80027-3.

    PMID: 9213382BACKGROUND
  • Tutoglu A, Boyaci A, Koca I, Celen E, Korkmaz N. Quality of life, depression, and sexual dysfunction in spouses of female patients with fibromyalgia. Rheumatol Int. 2014 Aug;34(8):1079-84. doi: 10.1007/s00296-014-2944-z. Epub 2014 Jan 9.

    PMID: 24402006BACKGROUND

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

DEMET FERAHMAN, MD

CONTACT

OMER BUCAK, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 10, 2024

Study Start

June 15, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

May 30, 2024

Record last verified: 2024-05