Norwegian COgnitive Impairment After STroke (NorCOAST) Study

Stroke Clinical Trial

— Nor-Coast  

Official title:

Norwegian COgnitive Impairment After STroke (NorCOAST) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650531
• Other study ID #: 2015/171/REK nord
• Status: Completed
• Start date: May 2015
• Est. completion date: October 8, 2018

Study information

• Verified date: February 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective observational multicenter study aiming to describe incidence, and identify predictors for development of poststroke dementia (PSD) and mild cognitive impairment (MCI) after stroke

Description:

About 15000 Norwegians suffer a stroke every year and 2/3 will be more or less disabled. In addition to motor impairments and comorbidities, disability after stroke is often related to post stroke dementia (PSD) or mild neurocognitive disorder (NCD). However, these problems are hardly addressed in stroke or dementia research and frequently ignored in clinical practise. In the Nor-COAST study an interdisciplinary research group will collaborate to establish a research platform across all Norwegian Health Authorities. The overall aim of the study is to improve competence on PSD and NCD in order to improve individual health outcomes following a stroke. The specific objectives are to determine the incidence of PSD and NCD and the consequences on function and use of health care services and to enhance the early detection of PSD and NCD by identifying a set of risk factors, ranging from genetics to physical activity. The incidence and impact of PSD and NCD on function and use of health care services, medication and life-style changes are important when planning future health care services. Tools identifying patients at risk might improve diagnostic work up and together with knowledge on pathogenic aspects it will contribute to future treatment and prevention of PSD and NCD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 816
• Est. completion date: October 8, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stroke diagnosis according to the WHO criteria

Exclusion Criteria:

• Not scandinavian speaking

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Stroke

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Haukeland University Hospital, Ullevaal University Hospital, University Hospital of North Norway, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Thingstad P, Askim T, Beyer MK, Bråthen G, Ellekjær H, Ihle-Hansen H, Knapskog AB, Lydersen S, Munthe-Kaas R, Næss H, Pendlebury ST, Seljeseth YM, Saltvedt I. The Norwegian Cognitive impairment after stroke study (Nor-COAST): study protocol of a multicentre, prospective cohort study. BMC Neurol. 2018 Nov 26;18(1):193. doi: 10.1186/s12883-018-1198-x. — View Citation

Wæhler IS, Saltvedt I, Lydersen S, Fure B, Askim T, Einstad MS, Thingstad P. Association between in-hospital frailty and health-related quality of life after stroke: the Nor-COAST study. BMC Neurol. 2021 Mar 4;21(1):100. doi: 10.1186/s12883-021-02128-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Montreal cognitive assessment (MOCA)	Performance based test	18 months
Secondary	Score on the Montreal cognitive assessment (MOCA)	Performance based test	3 months
Secondary	Time spent in upright position	measured by bodyworn sensors	3 months
Secondary	Time spent in upright position	measured by bodyworn sensors	18 months
Secondary	Brain Imaging	MRI	18 months
Secondary	Score on Short Physical Performance Battery (sppb)	Performance based test for mobility and lower extremity function	3 months
Secondary	Score on Short Physical Performance Battery (sppb)	Physical function by performance based tests	18 months
Secondary	Selfreported habits concerning smoking, alcohol, diet and medication using standardised questionnaires		3 months
Secondary	Selfreported habits concerning smoking, alcohol, diet and medication using standardised questionnaires		18 months