Stroke and Rehabilitation in North of Norway and Central... | NCT03948906

Studies
Stroke and Rehabilitation in North of Norway and Central Denmark

NCT03948906

Sponsor

University Hospital of North Norway

Status

Unknown status

Last Update Posted

Oct 13, 2022Actual

Enrollment

815Actual

Phase

Not provided

Conditions

Stroke, Acute

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014Actual

Primary Completion Date

Jul 2020Actual

Completion Date

Dec 2023Estimated

First Submitted Date

May 10, 2019

First Submission Date that Met QC Criteria

May 10, 2019

First Posted Date

May 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2022

Last Update Posted Date

Oct 13, 2022Actual

Name	Class
Regionshospitalet Hammel Neurocenter	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. A questionnaire package was mailed to the participants 3- and 12-months post stroke. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation.

Detailed Description

Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation. A questionnaire package was mailed to the participants 3- and 12-months post stroke. These included validated Questionnaires like QOLIBRI-OS, HADS, SS-QOL and EQ5D.

Validity studies on QOLIBRI-OS and SS-QOL has been published, along with several other papers. Synne Garder Pedersen and Guri Heiberg have finished their PhDs.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

815Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HRQOL	HRQOL measured by QOLIBRI-OS	2014- 2016

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Clinical diagnosis acute ischemic or hemmorhagic stroke
Inclusion period Mars 2014 to January 2016
Hospitalised in Stroke Units
Living in a defined geographic area in North of Norway or in Central Denmark

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with ischemic or hemorrhagic stroke

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29344360	Background	Pedersen SG, Heiberg GA, Nielsen JF, Friborg O, Stabel HH, Anke A, Arntzen C. Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale. SAGE Open Med. 2018 Jan 8;6:2050312117752031. doi: 10.1177/2050312117752031. eCollection 2018.
30021558	Result	Heiberg G, Pedersen SG, Friborg O, Nielsen JF, Holm HS, Steinbuchel von N, Arntzen C, Anke A. Can the health related quality of life measure QOLIBRI- overall scale (OS) be of use after stroke? A validation study. BMC Neurol. 2018 Jul 18;18(1):98. doi: 10.1186/s12883-018-1101-9.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases