Health, Functioning, Work, and Experiences of Social and Health Services of Persons With Stroke (FinPostStroke)

August 26, 2024 updated by: The Finnish Association of People with Physical Disabilities

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

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.

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

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 (Estimated)

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.
7500

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
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00280
        • The Finnish Association of People with Physical Disabilities

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

Probability 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.

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

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.
Persons treated in Kuopio University Hospital
Other: no intervention
no intervention
Persons treated in HUS Helsinki University Hospital
Other: no intervention
no intervention

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
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

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.
The Finnish Association of People with Physical Disabilities

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kuopio University Hospital
HUS Helsinki University Hospital
The Finnish Brain Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sinikka Hiekkala, The Finnish Association of People with Physical Disabilities

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.
January 29, 2024

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.
December 31, 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.
December 31, 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).
August 21, 2024

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.
August 26, 2024

First Posted (Actual)

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.
August 28, 2024

Study Record Updates

Last Update Posted (Actual)

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.
August 28, 2024

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.
August 26, 2024

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.
August 1, 2024

More Information

Terms related to this study

Keywords

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.
  • pr42115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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