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Structured Post-stroke Follow-up in Malmö, Sweden (SUESIM) (SUESIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04295226
Recruitment Status : Completed
First Posted : March 4, 2020
Last Update Posted : March 6, 2020
Sponsor:
Collaborators:
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
Clinical Studies Sweden - Forum South
Lund University
Information provided by (Responsible Party):
Region Skane

Brief Summary:

Background Stroke-related medical complications and health problems are common among stroke survivors. Post-stroke Checklist (PSC), developed by an international expert group, and can be used as a clinical tool to identify common and treatable stroke-related health problems. PSC has not been systematically tested in Sweden.

Aims To test the feasibility of a structured and multimodal follow-up model for stroke systematically, to test the validity of the PSC as a screening tool for stroke-related health problems and to study the prevalence of, and changes over time, of stroke-related health problems Study population We plan to include 200 consecutive patients with acute stroke, treated in-hospital at Skåne University Hospital in Malmö and discharged straight to own home.

Procedure The intervention consists of a structured follow-up visit, managed by a stroke nurse, 3 months after stroke followed by a multidisciplinary team rounds resulting in an individual treatment plan for stroke-related health problems, and a final follow-up at 12 months.

Feasibility will be evaluated, as well as burden of stroke-related health problems and interventions prompted by the visits.

Researchers responsible for the study:

Teresa Ullberg, MD, Ph (Postdoctoral researcher) and Hélène Pessah-Rasmussen, MD, PhD, associate professor (PI).


Condition or disease Intervention/treatment
Stroke Other: Structured follow-up after stroke.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Structured Post-stroke Follow-up at Skåne University Hospital in Malmö, Sweden - a Feasibility and Validation Study (SUESIM)
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Group/Cohort Intervention/treatment
Participants in Structured post-stroke follow-up in Malmö

Consecutive patients with acute ischemic stroke or intracerebral hemorrhage, treated in-hospital at Skåne University Hospital in Malmö and discharged straight to own home.

The intervention consists of a structured follow-up visit, managed by a stroke nurse, 3 months after stroke followed by a multidisciplinary team rounds resulting in an individual treatment plan for stroke-related health problems, and a final follow-up at 12 months

Other: Structured follow-up after stroke.
Stroke-nurse managed follow-up 3 and 12 months after stroke and multidisciplinary rounds resulting in individual treatment plans for stroke-related health problems.




Primary Outcome Measures :
  1. Number of stroke-related health problems [ Time Frame: 1 year ]
    14-item Post-stroke Checklist, PSC, captures 14 stroke-related health problems. Scale ranges from 0-14 problems. We aim to analyse burden of problems as well as individual items.

  2. Number of interventions [ Time Frame: 1 year ]
    Number of new interventions for stroke-related health problems identified with PSC. No scale used, we calculate the number of interventions done.


Secondary Outcome Measures :
  1. Time to perform and record the semi-structured Post-Stroke Checklist (PSC) interview (minutes). [ Time Frame: 1 year ]
    Feasibility of the post-stroke checklist-based follow-up. No scale used, only time in minutes.

  2. Ability to complete all Post-Stroke Checklist (PSC) items (yes/no) [ Time Frame: 1 year ]
    Feasibility of the post-stroke checklist-based follow-up. No scale used. Dichotomous variable (yes/no)

  3. Patient satisfaction assessment [ Time Frame: 1 year ]
    Questionnaire on met needs and satisfaction with follow-up. Five dichotomous questions on met needs and satisfaction with follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with acute stroke, without dementia or other serious comorbidity, that can be discharged straight home. These patients have mild to moderate stroke and can be expected to be able to visit an out-patient clinic for follow-up and to benefit from a structured follow-up visit.
Criteria

Inclusion Criteria:

  • Acute stroke (ICD-10: ischemic stroke I.63 and intracerebral hemorrhage I.61)
  • Discharge to own home

Exclusion Criteria:

  • Co-morbidity such as dialysis, active cancer, severe heart failure or severe psychiatric illness or dementia
  • Patients with stroke, but who receive in-hospital treatment for another competing diagnosis
  • Already included with previous stroke
  • Does not want to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295226


Locations
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Sweden
Skåne university hospital
Malmö, Sweden, 205 02
Sponsors and Collaborators
Region Skane
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
Clinical Studies Sweden - Forum South
Lund University
Additional Information:
Publications:

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT04295226    
Other Study ID Numbers: 2017/1028
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
follow-up
post stroke checklist
complications
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases