Patient-reported Outcome Measures (PROMs) in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study (SYMPA)

Helsinki University Central Hospital (HUCH)

Status: Unknown

Conditions: Irritable Bowel Syndrome; Fibromyalgia; Dysphagia; Somatic Symptom; Chronic Fatigue Syndrome; Exhaustion; Syndrome; Fatigue

Treatments: Behavioral: Psychosocial interventions

Study type: Observational

Funder types: Other

Identifiers

NCT04667611

1159007

Details and patient eligibility

About

This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 3 patient groups

Mild

Treatment:

Behavioral: Psychosocial interventions

Moderate

Treatment:

Behavioral: Psychosocial interventions

Severe

Treatment:

Behavioral: Psychosocial interventions