Patient-reported Outcome Measures (PROMs) as Characteristics and Prognostic Factors in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Self-rated global health improvement
Study Overview
Brief Summary
This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.
Detailed Description
The Sympa Cohort study is a prospective, single site cohort study that consists of administration of PROMs questionnaires to patients that attend the Clinic for Functional Disorders at Helsinki University hospital (HUS). The questionnaires are handed out to the study population within seven days before their first visit at the clinic, and then at the following 3, 6 and 12 months. The study population consists of consecutive adult patients that are referred to the clinic either from other hospital units or primary care. The collected data will later be linked with national registries on diagnoses, medication use and work ability. The Sympa Cohort study may have implications in targeting the factors influencing functional outcomes and quality of life reported by patients with bodily stress syndrome. It will also form a quality register for the Clinic and characterize the first systematic collection of PROMs related to these disorders in Finland.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Self-rated global health improvement
Time Frame: 12 months
Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale
Functional ability
Time Frame: 12 months
Measured by WHODAS 2.0
Secondary Outcomes
- EUROHIS-QOL-8(3, 6 and 12 months)
- RS-14(3, 6 and 12 months)
- PHQ-9(3, 6 and 12 months)
- GAD-7(3, 6 and 12 months)
- 15D(3, 6 and 12 months)
- SSD-12(3, 6 and 12 months)
Investigators
Helena Liira
Chief Physician
Helsinki University Central Hospital