NCT03859063

Brief Summary

Despite the improved treatment of acute stroke over the past decades, those suffering from stroke still are at an increased risk of functional and cognitive decline in the long term. The most common consequences of stroke are functional impairments, cognitive impairments, depression and fatigue. These are also regarded as barriers to achieve optimal adherence to the guidelines regarding secondary prevention. The primary aim of this project is to evaluate the effectiveness of a multimodal individualized intervention to prevent functional decline in the long term after stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

February 11, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 11, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

5.5 years

First QC Date

February 11, 2019

Last Update Submit

September 9, 2025

Conditions

Keywords

RehabilitationCognitionPhysical FitnessCase ManagersSecondary prevention

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale (mRS)

    mRS is an ordinal scale ranging from 0 to 6 measuring global function. 0 denotes no symptoms while 6 denotes death.

    18 months

Secondary Outcomes (76)

  • Modified Rankin Scale (mRS)

    6 months

  • Modified Rankin Scale (mRS)

    12 months

  • Barthel Index

    6 months

  • Barthel Index

    12 months

  • Barthel Index

    18 months

  • +71 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Regular follow up by a community based stroke coordinator

Behavioral: Intervention

Control

ACTIVE COMPARATOR

Usual care

Behavioral: Control

Interventions

InterventionBEHAVIORAL

Participants randomized to the intervention arm will be followed with monthly meetings by a stroke coordinator for 18 months. The stroke coordinator will assess the patients risk factors within the domains of physical function, cognitive function, social function, medication and lifestyle factors and make a treatment plan targeting the individual needs for further follow-up.

Intervention
ControlBEHAVIORAL

Community based follow-up as usual

Also known as: Usual care
Control

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of first ever or recurrent stroke (ischemic stroke or hemorrhage)
  • mRS \< 5
  • Living in Trondheim, Skedsmo or Lørenskog municipality
  • Less than 10 points on Short Physical Performance Battery (SPPB) OR less than 26 points on Montreal Cognitive Assessment (MoCA) OR more than 27 points on the 7 item version of the Fatigue Severity Scale (FSS-7) OR more than 7 points on the depression or anxiety items on Hospital Anxiety and Depression Scale (HADS) OR reduced hand function (i.e. fails on Motor Assessment Scale - Advanced arm- and hand function, item 3)
  • Able to understand Norwegian
  • Able and willing to sign informed consent.

You may not qualify if:

  • Life expectancy \< 12 months
  • Other serious diseases, judged by the medical doctor to make it difficult to comply with the intervention (i.e. serious neurological diseases or drug abuse).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ålesund Hospital

Ålesund, 6017, Norway

Location

Akershus University Hospital

Lørenskog, Norway

Location

Vestre Viken Bærum Hospital

Sandvika, Norway

Location

St Olavs Hospital Stroke Unit

Trondheim, Norway

Location

Related Publications (3)

  • Askim T, Langlo SR, Bergh E, Dohl O, Ellekjaer H, Hokstad A, Ihle-Hansen H, Indredavik B, Lydersen S, Luzum G, Seljeseth Y, Skandsen T, Saltvedt I, Thommessen B. A multimodal individualized long-term intervention to prevent functional decline after stroke (LAST-long): a single blinded randomised controlled trial. Lancet Reg Health Eur. 2025 Nov 13;61:101531. doi: 10.1016/j.lanepe.2025.101531. eCollection 2026 Feb.

  • Askim T, Hokstad A, Bergh E, Dohl O, Ellekjaer H, Ihle-Hansen H, Indredavik B, Leer ASM, Lydersen S, Saltvedt I, Seljeseth Y, Thommessen B. Multimodal individualised intervention to prevent functional decline after stroke: protocol of a randomised controlled trial on long-term follow-up after stroke (LAST-long). BMJ Open. 2023 May 10;13(5):e069656. doi: 10.1136/bmjopen-2022-069656.

  • Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.

MeSH Terms

Conditions

Stroke

Interventions

Methods

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Jorunn Helbostad, phd prof

    Norwegian University for Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Single-blinded. The investigator and outcomes assessor will be blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A two armed parallel group randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

March 1, 2019

Study Start

April 11, 2019

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations