NCT04295226

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

April 28, 2019

Last Update Submit

March 4, 2020

Conditions

Stroke

Keywords

follow-uppost stroke checklistcomplications

Outcome Measures

Primary Outcomes (2)

  • Number of stroke-related health problems

    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.

    1 year

  • Number of interventions

    Number of new interventions for stroke-related health problems identified with PSC. No scale used, we calculate the number of interventions done.

    1 year

Secondary Outcomes (3)

  • Time to perform and record the semi-structured Post-Stroke Checklist (PSC) interview (minutes).

    1 year

  • Ability to complete all Post-Stroke Checklist (PSC) items (yes/no)

    1 year

  • Patient satisfaction assessment

    1 year

Study Arms (1)

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.

Interventions

Structured follow-up after stroke.OTHER

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

Participants in Structured post-stroke follow-up in Malmö

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne university hospital

Malmo, 205 02, Sweden

Location

Related Publications (11)

  • Ullberg T, Zia E, Petersson J, Norrving B. Doctor's follow-up after stroke in the south of Sweden: An observational study from the Swedish stroke register (Riksstroke). Eur Stroke J. 2016 Jun;1(2):114-121. doi: 10.1177/2396987316650597. Epub 2016 May 19.

    PMID: 31008273BACKGROUND

  • Kumar S, Selim MH, Caplan LR. Medical complications after stroke. Lancet Neurol. 2010 Jan;9(1):105-18. doi: 10.1016/S1474-4422(09)70266-2.

    PMID: 20083041BACKGROUND

  • Langhorne P, Stott DJ, Robertson L, MacDonald J, Jones L, McAlpine C, Dick F, Taylor GS, Murray G. Medical complications after stroke: a multicenter study. Stroke. 2000 Jun;31(6):1223-9. doi: 10.1161/01.str.31.6.1223.

    PMID: 10835436BACKGROUND

  • Ullberg T, Zia E, Petersson J, Norrving B. Perceived Unmet Rehabilitation Needs 1 Year After Stroke: An Observational Study From the Swedish Stroke Register. Stroke. 2016 Feb;47(2):539-41. doi: 10.1161/STROKEAHA.115.011670. Epub 2016 Jan 5.

    PMID: 26732564BACKGROUND

  • McKevitt C, Fudge N, Redfern J, Sheldenkar A, Crichton S, Rudd AR, Forster A, Young J, Nazareth I, Silver LE, Rothwell PM, Wolfe CD. Self-reported long-term needs after stroke. Stroke. 2011 May;42(5):1398-403. doi: 10.1161/STROKEAHA.110.598839. Epub 2011 Mar 24.

    PMID: 21441153BACKGROUND

  • von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.

    PMID: 18064739BACKGROUND

  • Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

    PMID: 27145936BACKGROUND

  • Murray J, Young J, Forster A, Ashworth R. Developing a primary care-based stroke model: the prevalence of longer-term problems experienced by patients and carers. Br J Gen Pract. 2003 Oct;53(495):803-7.

    PMID: 14601359BACKGROUND

  • Philp I, Brainin M, Walker MF, Ward AB, Gillard P, Shields AL, Norrving B; Global Stroke Community Advisory Panel. Development of a poststroke checklist to standardize follow-up care for stroke survivors. J Stroke Cerebrovasc Dis. 2013 Oct;22(7):e173-80. doi: 10.1016/j.jstrokecerebrovasdis.2012.10.016. Epub 2012 Dec 21.

    PMID: 23265778BACKGROUND

  • Ward AB, Chen C, Norrving B, Gillard P, Walker MF, Blackburn S, Holloway L, Brainin M, Philp I; Global Stroke Community Advisory Panel (GSCAP). Evaluation of the Post Stroke Checklist: a pilot study in the United Kingdom and Singapore. Int J Stroke. 2014 Oct;9 Suppl A100:76-84. doi: 10.1111/ijs.12291. Epub 2014 Aug 4.

    PMID: 25088427BACKGROUND

  • Mansson K, Soderholm M, Berhin I, Pessah-Rasmussen H, Ullberg T. The Post-Stroke Checklist: longitudinal use in routine clinical practice during first year after stroke. BMC Cardiovasc Disord. 2024 Oct 29;24(1):601. doi: 10.1186/s12872-024-04239-6.

    PMID: 39468444DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2019

First Posted

March 4, 2020

Study Start

February 1, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)