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Completed

NCT Number: NCT03859063

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital, Lørenskog, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intervention

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

Behavioral

Community based follow-up as usual

Other names: Usual care

Primary outcomes

  1. Modified Rankin Scale (mRS)

    Time frame: 18 months

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

Secondary outcomes

  1. Modified Rankin Scale (mRS)

    Time frame: 6 months

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

  2. Modified Rankin Scale (mRS)

    Time frame: 12 months

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

  3. Barthel Index

    Time frame: 6 months

    ADL function

  4. Barthel Index

    Time frame: 12 months

    ADL function

  5. Barthel Index

    Time frame: 18 months

    ADL function

  6. Nottingham IADL

    Time frame: 6 months

    Extended activities of daily life (ADL) function

  7. Nottingham IADL

    Time frame: 12 months

    Extended activities of daily life (ADL) function

  8. Nottingham IADL

    Time frame: 18 months

    Extended activities of daily life (ADL) function

  9. Stroke Impact Scale (SIS)

    Time frame: 6 months

    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.

  10. Stroke Impact Scale (SIS)

    Time frame: 12 months

    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.

  11. Stroke Impact Scale (SIS)

    Time frame: 18 months

    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.

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 18 months

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

  15. Short Physical Performance Battery (SPPB)

    Time frame: 6 months

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

  16. Short Physical Performance Battery (SPPB)

    Time frame: 12 months

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

  17. Short Physical Performance Battery

    Time frame: 18 months

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

  18. Dynamometer

    Time frame: 6 months

    Grip strength

  19. Dynamometer

    Time frame: 12 months

    Grip strength

  20. Dynamometer

    Time frame: 18 months

    Grip strength

  21. 6 Minute Walk Test

    Time frame: 6 months

    Endurance. Walking distance during 6 minutes.

  22. 6 Minute Walk Test

    Time frame: 12 months

    Endurance. Walking distance during 6 minutes.

  23. 6 Minute Walk Test

    Time frame: 18 months

    Endurance. Walking distance during 6 minutes.

  24. ActivPAL

    Time frame: 6 months

    Activity monitoring across seven days

  25. ActivPAL

    Time frame: 12 months

    Activity monitoring across seven days

  26. ActivPAL

    Time frame: 18 months

    Activity monitoring across seven days

  27. Montreal Cognitive Assessment

    Time frame: 6 months

    Cognitive function

  28. Montreal Cognitive Assessment

    Time frame: 12 months

    Cognitive function

  29. Montreal Cognitive Assessment

    Time frame: 18 months

    Cognitive function

  30. Trail making test A and B

    Time frame: 6 months

    Executive function

  31. Trail making test A and B

    Time frame: 12 months

    Executive function

  32. Trail making test A and B

    Time frame: 18 months

    Executive function

  33. Global Deterioration Scale (GDS)

    Time frame: 6 months

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

  34. Global Deterioration Scale (GDS)

    Time frame: 12 months

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

  35. Global Deterioration Scale (GDS)

    Time frame: 18 months

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

  36. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 6 months

    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.

  37. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 12 months

    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.

  38. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 18 months

    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.

  39. Fatigue Severity Scale (FSS-7)

    Time frame: 6 months

    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.

  40. Fatigue Severity Scale (FSS-7)

    Time frame: 12 months

    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.

  41. Fatigue Severity Scale (FSS-7)

    Time frame: 18 months

    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.

  42. Part 2 of the Client Service Receipt Inventory

    Time frame: 6 months

    A measure of caregivers work participation and absenteeism

  43. Part 2 of the Client Service Receipt Inventory

    Time frame: 12 months

    A measure of caregivers work participation and absenteeism

  44. Part 2 of the Client Service Receipt Inventory

    Time frame: 18 months

    A measure of caregivers work participation and absenteeism

  45. Total cholesterol

    Time frame: 6 months

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

  46. Total cholesterol

    Time frame: 12 months

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

  47. Total cholesterol

    Time frame: 18 months

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

  48. Low Density Lipoprotein (LDL)

    Time frame: 6 months

    The LDL level will be measured by a blood test

  49. Low Density Lipoprotein (LDL)

    Time frame: 12 months

    The LDL level will be measured by a blood test

  50. Low Density Lipoprotein (LDL)

    Time frame: 18 months

    The LDL level will be measured by a blood test

  51. High Density Lipoprotein (HDL)

    Time frame: 6 months

    The HDL level will be measured by a blood test

  52. High Density Lipoprotein (HDL)

    Time frame: 12 months

    The HDL level will be measured by a blood test

  53. High Density Lipoprotein (HDL)

    Time frame: 18 months

    The HDL level will be measured by a blood test

  54. Longterm blood sugar (HbA1c)

    Time frame: 6 months

    The HbA1c level will be measured by a blood test

  55. Longterm blood sugar (HbA1c)

    Time frame: 12 months

    The HbA1c level will be measured by a blood test

  56. Longterm blood sugar (HbA1c)

    Time frame: 18 months

    The HbA1c level will be measured by a blood test

  57. Hemoglobin

    Time frame: 6 months

    The hemoglobin level will be measured by a blood test

  58. Hemoglobin

    Time frame: 12 months

    The hemoglobin level will be measured by a blood test

  59. Hemoglobin

    Time frame: 18 months

    The hemoglobin level will be measured by a blood test

  60. Creatinine

    Time frame: 6 months

    The creatinine level will be measured by a blood test

  61. Creatinine

    Time frame: 12 months

    The creatinine level will be measured by a blood test

  62. Creatinine

    Time frame: 18 months

    The creatinine level will be measured by a blood test

  63. C-reactive protein (CRP)

    Time frame: 6 months

    The CRP level will be measured by a blood test

  64. C-reactive protein (CRP)

    Time frame: 12 months

    The CRP level will be measured by a blood test

  65. C-reactive protein (CRP)

    Time frame: 18 months

    The CRP level will be measured by a blood test

  66. Blood pressure

    Time frame: 6 months

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

  67. Blood pressure

    Time frame: 12 months

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

  68. Blood pressure

    Time frame: 18 months

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

  69. Body mass index (BMI)

    Time frame: 6 months

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

  70. Body mass index (BMI)

    Time frame: 12 months

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

  71. Body mass index (BMI)

    Time frame: 18 months

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

  72. Health care costs

    Time frame: 18 months

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

  73. Adherence to the intervention

    Time frame: 18 months

    Number of attended meetings with the stroke coordinator

  74. Exercise Adherence Rating Scale

    Time frame: 18 months

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

  75. Patient diaries

    Time frame: 18 months

    Adherence to the recommended and agreed activities

  76. Adverse events

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Alesund Hospital
  • Asker & Baerum Hospital
  • St. Olavs Hospital
  • University Hospital, Akershus

Registry information

Official study 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)

Acronym: LAST-long

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2019
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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