Long-term Follow-up After Stroke (The LAST-long Trial)

NCT ID: NCT03859063

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2024-12-31

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.

Detailed Description

In a clinical randomized controlled trial, 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.

Those randomized to the control group will receive standard care.

Patients living in the municipalities of Trondheim, Lørenskog and Skedsmo admitted to Akershus University Hospital or St. Olavs University Hospital will be included at the outpatients clinic 3 months after the stroke.

All patients will be re-assessed at 6, 12 and 18 months after inclusion. Primary outcome will be modified Rankin Scale at 18 months.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Regular follow up by a community based stroke coordinator

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

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.

Control

Usual care

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Community based follow-up as usual

Interventions

Intervention

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 Type: BEHAVIORAL

Control

Community based follow-up as usual

Intervention Type: BEHAVIORAL

Other Intervention Names

Usual care

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Asker & Baerum Hospital

OTHER

Sponsor Role: collaborator

Alesund Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorunn Helbostad, phd prof

Role: STUDY_DIRECTOR

Norwegian University for Science and Technology

Locations

Ålesund Hospital

Ålesund, , Norway

Akershus University Hospital

Lørenskog, , Norway

Vestre Viken Bærum Hospital

Sandvika, , Norway

St Olavs Hospital Stroke Unit

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 37164457 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35349186 (View on PubMed)

Other Identifiers

2018/1809

Identifier Type: -

Identifier Source: org_study_id