The Pilot of the Turku Outpatient Clinic for Functional and Fatigue Disorders (TOCliFFD)

November 26, 2025 updated by: Turku University Hospital

The Pilot of the Turku Outpatient Clinic for Functional and Fatigue Disorders in the Welbeing Services County of Southwest Finland

This study examined 125 working-age patients from the Turku Outpatient Clinic for Functional and Fatigue Disorders. "Patients participate in the clinic's biopsychosocial, multidisciplinary, and individually tailored rehabilitation. The aim of the rehabilitation is to improve patients' functional capacity and provide them with tools to manage and cope with their symptoms. In addition, the goal is to break the cycle of unnecessary examinations that cause harm to the patient. Socioeconomic data, as well as information related to functional capacity, symptoms, and quality of life, are collected from patients at the start of rehabilitation and again at six and twelve months after the beginning of rehabilitation. In addition, data on patients' use of social and health care services are requested from registers for the year preceding the start of rehabilitation and for the year following rehabilitation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Academic Health and Social Services Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of working-age patients with persistent symptoms in the wellbeing services county of Southwest Finland. Referrals to the clinic were made from primary health care, occupational health care, private health services, and specialized health care.

Description

Inclusion Criteria:

  • patients suffering persistent symptoms
  • referred to the clinic between August 1, 2023 to April 30, 2025

Exclusion Criteria:

  • ineligible for the study because of the need for extensive additional examinations in a specialized field, acute substance abuse problems, and/or lack of motivation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients suffering persistent symptoms
The clinic's staff included a pilot project coordinator, a physician, an occupational therapist, a physiotherapist, a psychologist, a rehabilitation counselor, and a ward secretary. At the physician's initial visit, stress system sensitization, burden factors, and need for symptomatic medication were assessed. In a joint rehabilitation team meeting, the patient met a psychologist, occupational therapist, physiotherapist, and rehabilitation counselor, who conducted a multidisciplinary evaluation and created an individualized rehabilitation plan. Patients then attended a course for persistent bodily symptoms, with some joining a psychophysical breathing group. Individual rehabilitation or counseling was provided according to each patient's needs.
Behavioral: Biopsychosocial, multidisciplinary, and individually tailored rehabilitation for patients with persisten symptoms
The clinic's staff included a pilot project coordinator, a physician, an occupational therapist, a physiotherapist, a psychologist, a rehabilitation counselor, and a ward secretary. At the physician's initial visit, stress system sensitization, burden factors, and need for symptomatic medication were assessed. In a joint rehabilitation team meeting, the patient met a psychologist, occupational therapist, physiotherapist, and rehabilitation counselor, who conducted a multidisciplinary evaluation and created an individualized rehabilitation plan. Patients then attended a course for persistent bodily symptoms, with some joining a psychophysical breathing group. Individual rehabilitation or counseling was provided according to each patient's needs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of life of the patients
Time Frame: At baseline and at 6 and 12 months follow-ups
WHOQOL-BREF
At baseline and at 6 and 12 months follow-ups

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional limitations of the patients
Time Frame: At baseline and at 6 and 12 months follow-up
WHODAS 2.0
At baseline and at 6 and 12 months follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Use of social and health services
Time Frame: At baseline and at 6 and 12 month follow-ups
Number of visits and service fee per visits
At baseline and at 6 and 12 month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T1398-2023-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Only upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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