- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06575907
Health, Functioning, Work, and Experiences of Social and Health Services of Persons With Stroke (FinPostStroke)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of the Health, functioning, work, and experiences of social and health services of persons with stroke (FinPostStroke) study 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. The International Classification of Functioning, Disability and Health (ICF) is used as a structured framework.
Adults with cerebral infarction, subarachnoid hemorrhage, or intracerebral hemorrhage will be targeted from Kuopio and HUS Helsinki University Hospitals' patient registries. The survey data is planned to be collected with postal questionnaire by May 2025. The questionnaire includes several valid patient-reported outcome measures to assess health and functioning, work and income, inclusion, and social and health services. Participants will be recruited via mail with an invitation letter and study information attached to the questionnaire. All participants are expected to give written informed consent prior to the study.
This 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. We plan to publish at least four peer-reviewed articles along with common articles and texts concerning self-reported health, functioning, work, inclusion, and accessibility of social and health services among Finnish adults with stroke.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Uusimaa
-
Helsinki, Uusimaa, Finland, 00280
- The Finnish Association of People with Physical Disabilities
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- 18 years or older at the time of survey
Exclusion Criteria:
- stroke is secondary diagnose for the treatment
- treated for a stroke only as outpatient in other than emergency room
- lives abroad
- missing address
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Persons treated in Kuopio University Hospital
|
no intervention
|
|
Persons treated in HUS Helsinki University Hospital
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS® Global Health
Time Frame: 7 days
|
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
Time Frame: 7 days
|
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
Time Frame: 30 days
|
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
Time Frame: 1 day
|
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
Time Frame: 1 year
|
"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
Time Frame: 30 days
|
"Work and income" consists of 14 semistructured questions about work and income chosen from the International Spinal Cord Injury Survey.
|
30 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sinikka Hiekkala, The Finnish Association of People with Physical Disabilities
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pr42115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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