NCT01582620

Brief Summary

The purpose is to study the clinical, technological and organizational impacts of a telestroke service between Nordlandssykehuset, Bodø, and two small rural hospitals in Lofoten and Vesterålen. The stroke specialist in Bodø will examine the patient in cooperation with the doctor at the local hospital through video- and sound communication. Radiology images are transmitted using the RIS/PACS system. Telestroke consultations may be useful to assess whether the patient needs thrombolysis medication, and also whether there is a need for more advanced specialist neurological or neurosurgical treatment, supporting quick triaging and transfer to the appropriate unit. The study design is a multi-method approach using before-and-after hospital information data as well as registration forms monitoring patient outcome and pathways. The research questions will be approached from medical, organisational and technological perspectives. A telestroke service in North Norway is expected to face other challenges than those reported internationally: In Nordlandssykehuset, as in Helse Nord in general, the number of cases is low, clinicians have high turnover, technical support is not available 24/7 and severe weather conditions and long distances might add to the transport time. Primary hypothesis: The use of telestroke leads to faster and more accurate diagnosis and proper treatment Secondary hypothesis: Telestroke leads to improved overall patient treatment

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2020

Completed
Last Updated

March 26, 2020

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

May 26, 2011

Last Update Submit

March 24, 2020

Conditions

Keywords

Cerebrovascular disordersTelemedicineremote consultationruralthrombolysis therapyplasminogen activatorsstroke carestroke management

Outcome Measures

Primary Outcomes (1)

  • Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service

    Approx. 30 months

Secondary Outcomes (4)

  • Door-to-(thrombolysis)needle-time

    18 months

  • Scores for functional outcomes at admission and discharge

    18 months

  • Proportion of patient transfers from Lofoten and Vesterålen in the acute phase to secondary level

    18 months

  • Proportion of stroke patients receiving "telestroke" examination

    18 months

Interventions

TelestrokePROCEDURE

remote videoconference consultations

Eligibility Criteria

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

You may qualify if:

  • Patients admitted to the two local hospitals diagnosed with acute cerebral stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nordlandssykehuset HF Lofoten

Gravdal, Nordland, 8372, Norway

Location

Nordlandssykehuset HF Vesterålen

Stokmarknes, Norway

Location

MeSH Terms

Conditions

StrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Heidi Jacobsen

    Norwegian center for integrated care and telemedicine, Tromsø Norway

    STUDY DIRECTOR
  • Rolf Salvesen, PhD professor

    Neurological department, Nordlandssykehuset HF

    PRINCIPAL INVESTIGATOR
  • Stein Roald Bolle, PhD

    Norwegian center for integrated care and telemedicine, University Hospital North Norway, Tromsø

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2011

First Posted

April 20, 2012

Study Start

August 1, 2011

Primary Completion

December 1, 2012

Study Completion

March 24, 2020

Last Updated

March 26, 2020

Record last verified: 2012-04

Locations