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StrokeLAST-longNCT03859063

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

A study testing Intervention in people with Stroke, run by Norwegian University of Science and Technology at 4 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
4 sitesNorway
Study dates
11 Apr 2019to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country.

Norway4 sites
  • Ålesund Hospital

    Ålesund, 6017

  • Akershus University Hospital

    Lørenskog

  • Vestre Viken Bærum Hospital

    Sandvika

  • St Olavs Hospital Stroke Unit

    Trondheim

Other trials in Norway

About this study

Official title: A Multimodal Individualized Intervention to Prevent Functional Decline After Stroke. A Randomized Controlled Trial on Long-term Follow-up After Stroke (The LAST-long Trial)

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.

Read the 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
Being tested
Intervention, Control
Keywords
Rehabilitation, Cognition, Physical Fitness, Case Managers, Secondary prevention
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    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.

  • ControlBehavioural

    Also called Usual care

    Community based follow-up as usual

Study groups in NCT03859063
Study groupRoleWhat they receive
InterventionExperimentalRegular follow up by a community based stroke coordinator
Receives: Behavioral: Intervention
ControlActive comparatorUsual care
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months

Secondary outcomes (76)
  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.

    Measured: 6 months

  2. 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.

    Measured: 12 months

  3. Barthel Index

    ADL function

    Measured: 6 months

  4. Barthel Index

    ADL function

    Measured: 12 months

  5. Barthel Index

    ADL function

    Measured: 18 months

  6. Nottingham IADL

    Extended activities of daily life (ADL) function

    Measured: 6 months

  7. Nottingham IADL

    Extended activities of daily life (ADL) function

    Measured: 12 months

  8. Nottingham IADL

    Extended activities of daily life (ADL) function

    Measured: 18 months

  9. Stroke Impact Scale (SIS)

    SIS is a stroke specific quality of life measure, that measures self perceived health within nine domains. The scale within each domain range from 0 to 100 and higher score denotes better health.

    Measured: 6 months

  10. Stroke Impact Scale (SIS)

    SIS is a stroke specific quality of life measure, that measures self perceived health within nine domains. The scale within each domain range from 0 to 100 and higher score denotes better health.

    Measured: 12 months

  11. Stroke Impact Scale (SIS)

    SIS is a stroke specific quality of life measure, that measures self perceived health within nine domains. The scale within each domain range from 0 to 100 and higher score denotes better health.

    Measured: 18 months

  12. The 5-level EQ-5D version (EQ-5D-5L)

    EQ-5D-5L is a generic quality of life measure reporting self perceived health within five domains.

    Measured: 6 months

  13. The 5-level EQ-5D version (EQ-5D-5L)

    EQ-5D-5L is a generic quality of life measure reporting self perceived health within five domains.

    Measured: 12 months

  14. The 5-level EQ-5D version (EQ-5D-5L)

    EQ-5D-5L is a generic quality of life measure reporting self perceived health within five domains.

    Measured: 18 months

  15. Short Physical Performance Battery (SPPB)

    SPPB is a composite scale measuring gait and balance. The scale ranges from 0 to 12 points. Higher score denotes better function.

    Measured: 6 months

  16. Short Physical Performance Battery (SPPB)

    SPPB is a composite scale measuring gait and balance. The scale ranges from 0 to 12 points. Higher score denotes better function.

    Measured: 12 months

  17. Short Physical Performance Battery

    SPPB is a composite scale measuring gait and balance. The scale ranges from 0 to 12 points. Higher score denotes better function.

    Measured: 18 months

  18. Dynamometer

    Grip strength

    Measured: 6 months

  19. Dynamometer

    Grip strength

    Measured: 12 months

  20. Dynamometer

    Grip strength

    Measured: 18 months

  21. 6 Minute Walk Test

    Endurance. Walking distance during 6 minutes.

    Measured: 6 months

  22. 6 Minute Walk Test

    Endurance. Walking distance during 6 minutes.

    Measured: 12 months

  23. 6 Minute Walk Test

    Endurance. Walking distance during 6 minutes.

    Measured: 18 months

  24. ActivPAL

    Activity monitoring across seven days

    Measured: 6 months

  25. ActivPAL

    Activity monitoring across seven days

    Measured: 12 months

  26. ActivPAL

    Activity monitoring across seven days

    Measured: 18 months

  27. Montreal Cognitive Assessment

    Cognitive function

    Measured: 6 months

  28. Montreal Cognitive Assessment

    Cognitive function

    Measured: 12 months

  29. Montreal Cognitive Assessment

    Cognitive function

    Measured: 18 months

  30. Trail making test A and B

    Executive function

    Measured: 6 months

  31. Trail making test A and B

    Executive function

    Measured: 12 months

  32. Trail making test A and B

    Executive function

    Measured: 18 months

  33. Global Deterioration Scale (GDS)

    GDS is a measure of global cognitive function. A score of 1 denotes no symptoms while a score of 7 denotes serious dementia.

    Measured: 6 months

  34. Global Deterioration Scale (GDS)

    GDS is a measure of global cognitive function. A score of 1 denotes no symptoms while a score of 7 denotes serious dementia.

    Measured: 12 months

  35. Global Deterioration Scale (GDS)

    GDS is a measure of global cognitive function. A score of 1 denotes no symptoms while a score of 7 denotes serious dementia.

    Measured: 18 months

  36. Hospital Anxiety and Depression Scale (HADS)

    The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

    Measured: 6 months

  37. Hospital Anxiety and Depression Scale (HADS)

    The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

    Measured: 12 months

  38. Hospital Anxiety and Depression Scale (HADS)

    The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

    Measured: 18 months

  39. Fatigue Severity Scale (FSS-7)

    The seven item version of Fatigue Severity Scale is a method of evaluating the impact of fatigue. FSS-7 contains seven statements that rate the severity of fatigue. Each item is scored from 1 to 7. Higher score is indicating more fatigue.

    Measured: 6 months

  40. Fatigue Severity Scale (FSS-7)

    The seven item version of Fatigue Severity Scale is a method of evaluating the impact of fatigue. FSS-7 contains seven statements that rate the severity of fatigue. Each item is scored from 1 to 7. Higher score is indicating more fatigue.

    Measured: 12 months

  41. Fatigue Severity Scale (FSS-7)

    The seven item version of Fatigue Severity Scale is a method of evaluating the impact of fatigue. FSS-7 contains seven statements that rate the severity of fatigue. Each item is scored from 1 to 7. Higher score is indicating more fatigue.

    Measured: 18 months

  42. Part 2 of the Client Service Receipt Inventory

    A measure of caregivers work participation and absenteeism

    Measured: 6 months

  43. Part 2 of the Client Service Receipt Inventory

    A measure of caregivers work participation and absenteeism

    Measured: 12 months

  44. Part 2 of the Client Service Receipt Inventory

    A measure of caregivers work participation and absenteeism

    Measured: 18 months

  45. Total cholesterol

    The level of total cholesterol will be measured by a blood test

    Measured: 6 months

  46. Total cholesterol

    The level of total cholesterol will be measured by a blood test

    Measured: 12 months

  47. Total cholesterol

    The level of total cholesterol will be measured by a blood test

    Measured: 18 months

  48. Low Density Lipoprotein (LDL)

    The LDL level will be measured by a blood test

    Measured: 6 months

  49. Low Density Lipoprotein (LDL)

    The LDL level will be measured by a blood test

    Measured: 12 months

  50. Low Density Lipoprotein (LDL)

    The LDL level will be measured by a blood test

    Measured: 18 months

  51. High Density Lipoprotein (HDL)

    The HDL level will be measured by a blood test

    Measured: 6 months

  52. High Density Lipoprotein (HDL)

    The HDL level will be measured by a blood test

    Measured: 12 months

  53. High Density Lipoprotein (HDL)

    The HDL level will be measured by a blood test

    Measured: 18 months

  54. Longterm blood sugar (HbA1c)

    The HbA1c level will be measured by a blood test

    Measured: 6 months

  55. Longterm blood sugar (HbA1c)

    The HbA1c level will be measured by a blood test

    Measured: 12 months

  56. Longterm blood sugar (HbA1c)

    The HbA1c level will be measured by a blood test

    Measured: 18 months

  57. Hemoglobin

    The hemoglobin level will be measured by a blood test

    Measured: 6 months

  58. Hemoglobin

    The hemoglobin level will be measured by a blood test

    Measured: 12 months

  59. Hemoglobin

    The hemoglobin level will be measured by a blood test

    Measured: 18 months

  60. Creatinine

    The creatinine level will be measured by a blood test

    Measured: 6 months

  61. Creatinine

    The creatinine level will be measured by a blood test

    Measured: 12 months

  62. Creatinine

    The creatinine level will be measured by a blood test

    Measured: 18 months

  63. C-reactive protein (CRP)

    The CRP level will be measured by a blood test

    Measured: 6 months

  64. C-reactive protein (CRP)

    The CRP level will be measured by a blood test

    Measured: 12 months

  65. C-reactive protein (CRP)

    The CRP level will be measured by a blood test

    Measured: 18 months

  66. Blood pressure

    Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer

    Measured: 6 months

  67. Blood pressure

    Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer

    Measured: 12 months

  68. Blood pressure

    Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer

    Measured: 18 months

  69. Body mass index (BMI)

    BMI calculated as kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared

    Measured: 6 months

  70. Body mass index (BMI)

    BMI calculated as kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared

    Measured: 12 months

  71. Body mass index (BMI)

    BMI calculated as kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared

    Measured: 18 months

  72. Health care costs

    Data from available registries will be used to estimate costs in Euro

    Measured: 18 months

  73. Adherence to the intervention

    Number of attended meetings with the stroke coordinator

    Measured: 18 months

  74. Exercise Adherence Rating Scale

    Exercise Adherence Rating Scale measures the level of adherence to the recommended and agreed activities and the reasons for not adhering.

    Measured: 18 months

  75. Patient diaries

    Adherence to the recommended and agreed activities

    Measured: 18 months

  76. Adverse events

    Adverse events will be registered to assess the safety of the intervention.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start11 Apr 2019
  3. Primary completion30 Sep 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A two armed parallel group randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859063
Sponsor's protocol ID
2018/1809
Acronym
LAST-long
Status last verified
Sep 2025
First submitted
11 Feb 2019
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ihle-Hansen H, Thommessen B, Langlo SR, Bergh E, Hokstad A, Lydersen S, Seljeseth Y, Saltvedt I, Askim T. Impact of age and frailty on the effect of a multimodal individualized long-term intervention after stroke: the last-long trial. J Rehabil Med. 2026 Oct 26;58:jrm46250. doi: 10.2340/jrm.v58.46250.

    PubMed 42929098
  • 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.

    PubMed 41323876
  • 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.

    PubMed 37164457
  • 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.

    PubMed 35349186

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Stroke, run by Norwegian University of Science and Technology at 4 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (mRS) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859063, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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