Fibromyalgia Clinical Trial
— SYMPAOfficial title:
Patient-reported Outcome Measures (PROMs) as Characteristics and Prognostic Factors in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study
NCT number | NCT04667611 |
Other study ID # | 1159007 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 9, 2020 |
Est. completion date | December 2023 |
This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - All genders - Age 18-80 years - Referred to Clinic for Functional Disorders either from other hospital units or from primary care - Willingness to be enrolled in the study, by signing the informed consent Exclusion Criteria: - Patients not able to fill in the forms in Finnish or due to physical constraints (e.g. dystonia) - Symptoms are likely due to a somatic disorder |
Country | Name | City | State |
---|---|---|---|
Finland | Clinic for Functional Disorders, Helsinki University Hospital | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-rated global health improvement | Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale | 12 months | |
Primary | Functional ability | Measured by WHODAS 2.0 | 12 months | |
Secondary | PHQ-9 | Depression | 3, 6 and 12 months | |
Secondary | GAD-7 | Anxiety | 3, 6 and 12 months | |
Secondary | EUROHIS-QOL-8 | Health related quality of life | 3, 6 and 12 months | |
Secondary | 15D | Health related quality of life | 3, 6 and 12 months | |
Secondary | SSD-12 | Symptom severity | 3, 6 and 12 months | |
Secondary | RS-14 | Resilience | 3, 6 and 12 months |
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