NCT06575907

Brief Summary

The purpose of the Health, functioning, work, and experiences of social and health services of persons with stroke study (FinPostStroke) is to identify factors related to self-reported health, functioning, work, inclusion, and accessibility of social and health services, and how such factors are interconnected in Finnish adults one or more years after stroke. Participants will be targeted from two tertiary hospitals' registries and recruited via mail. This cross-sectional explorative observational study is based on register data and postal survey. The survey questionnaire includes several valid patient-reported outcome measures. The study will add knowledge to be utilized in developing health care and rehabilitation services for people with stroke, as well as provide information for various parties involved.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2024Dec 2027

Study Start

First participant enrolled

January 29, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

August 21, 2024

Last Update Submit

August 26, 2024

Conditions

Keywords

ICFSurveyStrokeHealthFunctioningWorkInclusionHealth and social services

Outcome Measures

Primary Outcomes (6)

  • PROMIS® Global Health

    The Patient-Reported Outcomes Measurement Information System (PROMIS®) General Health consists of 10 items with 5-point rating scale. It is used to assess overall health, physical health, mental health, social health, fatigue, and pain.

    7 days

  • PROMIS® 29+2 Profile

    The Patient-Reported Outcomes Measurement Information System (PROMIS®) 29+2 Profile consists of 31 items with 5-point rating scale. It is used to assess physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference and intensity, and cognitive function.

    7 days

  • 12-item WHODAS 2.0

    The 12-item World Health Organization Disability Schedule 2.0 (WHODAS) measures functioning. It consists of 12 items with 5-point rating scale (0-4), sum score ranging from 0 to 48. Higher score means more disability. It is used to assess cognition, mobility, self-care, getting along, life activities, and participation.

    30 days

  • Experiences of Social Inclusion Scale, ESIS

    Experiences of Social Inclusion Scale (ESIS) consists of 10 claims with 5-point Likert scale (1-5). The sum score of 10-50 is converted to a scale of 0 to 100. Higher score means stronger experience of inclusion. It is used to assess the experience of meaningfulness, belief in action possibilities and the perceived quality of social interaction.

    1 day

  • Health and social services

    "Health and social services" consists of 24 semistructured questions about health and social services chosen from the National Health Finland Survey.

    1 year

  • Work and income

    "Work and income" consists of 14 semistructured questions about work and income chosen from the International Spinal Cord Injury Survey.

    30 days

Study Arms (2)

Persons treated in Kuopio University Hospital

Other: no intervention

Persons treated in HUS Helsinki University Hospital

Other: no intervention

Interventions

no intervention

Persons treated in HUS Helsinki University HospitalPersons treated in Kuopio University Hospital

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with cerebral infarction, subarachnoid hemorrhage, or intracerebral hemorrhage that have been treated either in Kuopio or HUS Helsinki University Hospitals in 2018-2022.

You may qualify if:

  • treated for a stroke (ICD-10 codes I60-61, I63-64) in HUS Helsinki University Hospital or in Kuopio University Hospital between January 2018 and December 2022
  • stroke is primary diagnose for the treatment
  • years or older at the time of survey

You may not qualify if:

  • stroke is secondary diagnose for the treatment
  • treated for a stroke only as outpatient in other than emergency room
  • lives abroad
  • missing address

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Finnish Association of People with Physical Disabilities

Helsinki, Uusimaa, 00280, Finland

Location

MeSH Terms

Conditions

StrokeCardiovascular DiseasesCentral Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Sinikka Hiekkala

    The Finnish Association of People with Physical Disabilities

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 28, 2024

Study Start

January 29, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations