Clinical trial NCT04649814: Finnish Spinal Cord Injury Study (FinSCI)
Official title: Finnish Spinal Cord Injury Study (FinSCI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Health, Subjective
Keywords: patient reported outcomes
ICF
Survey
Interview
Lead sponsor: The Finnish Association of People with Physical Disabilities
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Tampere University Hospital
name: Oulu University Hospital
name: The Finnish Association of Spinal Cord Injured Akson
name: Finnish Institute for Health and Welfare
First posted: 2020-12-02
Enrollment: 1773
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute care, immediate rehabilitation and life-long multi-professional follow-up, care and rehabilitation of SCI have been centralised at 3 university hospitals: Oulu (OYS), Tampere (Tays) and Helsinki (HUS) university hospitals. They serve the whole SCI-population, both previously and newly injured, in their hospital district areas. The study participants were selected by exploring the patient registries in OYS, Tays and HUS. A more systematic data collection of the SCI population started in different outpatient clinics at different times (Tays 5/2011, OYS 1/2012 and in HUS 8/2013). The selection of patients for the study performed from the start of the systematic data collection and lasted in Tays and OYS till the end of 2017, and in HUS - till the end of June 2018.

Brief summary: The purpose of the Finnish Spinal Cord Injury Study (FinSCI) is to identify factors related to the health and functioning of people with spinal cord injury (SCI), their challenges with accessibility and how such factors are interconnected. The International Classification of Functioning, Disability and Health (ICF) is used in the study as a structured framework. The study participants will be recruited from three SCI outpatient clinics, which together are responsible for the life-time care of the SCI population in Finland.

Mixed methods are used including a questionnaire and interviews. The survey will be formed from patient-reported instruments; SCI-specified Spinal Cord Injury Secondary Condition Scale, Spinal Cord Independence Measure, Nottwil Environmental Factors Inventory Short Form and selected items of the generic instruments of Patient-Reported Outcomes Measurement Information System and National study of health, well-being and service. The survey covers 51 ICF categories. The study results can help develop care and rehabilitation policies with SCI, the planning of training models and information provided to various parties involved.

Detailed description: The detailed description of the protocol has been published. Please, see the reference Tallqvist et al.

Eligibility criteria: Inclusion Criteria:

* 16 years or over
* Traumatic or non-traumatic SCI
* ASIA-classification A,B,C tai D
* Time since onset of SCI over 6 months
* Client of HUS, Tays or Oys SCI outpatient clinic

Exclusion Criteria:

* Innate SCI
* Progressive new non-traumatic SCI
* Neurodegenerative disease
* Multiple sclerosis amyotrophic lateral sclerosisGuillain-Barre syndrome Institutional care

Primary outcomes:
measure: Cohort Survey of Health, Functioning, and accessibility of spinal cord injury population in Finland
timeFrame: 1.2.-31.7.2019
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: The Finnish Association of People with Physical Disabilities
state: Uusimaa
Study officials:
affiliation: Research Director
name: Hiekkala, PhD
role: STUDY_DIRECTOR
References:
citation: Tallqvist S, Anttila H, Kallinen M, Koskinen E, Hamalainen H, Kauppila AM, Tackman A, Vainionpaa A, Arokoski J, Hiekkala S. Health, functioning and accessibility among spinal cord injury population in Finland: Protocol for the FinSCI study. J Rehabil Med. 2019 Apr 1;51(4):273-280. doi: 10.2340/16501977-2539.
citation: Tallqvist S, Kauppila AM, Vainionpaa A, Koskinen E, Bergman P, Anttila H, Hamalainen H, Tackman A, Kallinen M, Arokoski J, Hiekkala S. Prevalence of comorbidities and secondary health conditions among the Finnish population with spinal cord injury. Spinal Cord. 2022 Jul;60(7):618-627. doi: 10.1038/s41393-021-00704-7. Epub 2021 Sep 11.
citation: Majamaki K, Tallqvist S, Vainionpaa A, Koskinen E, Kauppila AM, Bergman P, Anttila H, Hamalainen H, Tackman A, Kallinen M, Arokoski J, Hiekkala S. Functional independence in the Finnish spinal cord injury population. Spinal Cord. 2022 Jul;60(7):628-634. doi: 10.1038/s41393-021-00700-x. Epub 2021 Sep 15.
citation: Eskola K, Koskinen E, Anttila H, Tallqvist S, Bergman P, Kallinen M, Hamalainen H, Kauppila AM, Tackman A, Vainionpaa A, Arokoski J, Rajavaara M, Hiekkala S. Health-related factors for work participation in persons with spinal cord injury in Finland. J Rehabil Med. 2022 Feb 3;54:jrm00255. doi: 10.2340/jrm.v53.59.
citation: Poutanen J, Anttila H, Tallqvist S, Kallinen M, Koskinen E, Hamalainen H, Kauppila AM, Tackman A, Vainionpaa A, Arokoski J, Hiekkala S. Physical health among the Finnish spinal cord injury population according to the Patient Reported Outcome Measurement Information System (PROMIS(R)). J Spinal Cord Med. 2022 Nov;45(6):865-873. doi: 10.1080/10790268.2021.1989184. Epub 2021 Nov 2.