Clinical trial NCT04667611: Patient-reported Outcome Measures (PROMs) in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study
Official title: Patient-reported Outcome Measures (PROMs) as Characteristics and Prognostic Factors in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Irritable Bowel Syndrome
Somatic Symptom
Chronic Fatigue Syndrome
Fatigue
Dysphagia
Exhaustion; Syndrome
Keywords: bodily stress syndrome
functional somatic symptoms
functional somatic syndrome
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of consecutive patients referred to the Clinic for Functional Disorders and who give their consent to be followed up during one year after their visit to the clinic.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-rated global health improvement
timeFrame: 12 months
measure: Functional ability
timeFrame: 12 months
Secondary outcomes:
measure: PHQ-9
timeFrame: 3, 6 and 12 months
measure: GAD-7
timeFrame: 3, 6 and 12 months
measure: EUROHIS-QOL-8
timeFrame: 3, 6 and 12 months
measure: 15D
timeFrame: 3, 6 and 12 months
measure: SSD-12
timeFrame: 3, 6 and 12 months
measure: RS-14
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Clinic for Functional Disorders, Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Helena Liira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: