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

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03859063
Collaborator
St. Olavs Hospital (Other), University Hospital, Akershus (Other), Asker & Baerum Hospital (Other)
490
Enrollment
3
Locations
2
Arms
56.7
Anticipated Duration (Months)
163.3
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Intervention
  • Behavioral: Control
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
490 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A two armed parallel group randomized controlled trialA two armed parallel group randomized controlled trial
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Single-blinded. The investigator and outcomes assessor will be blinded to group allocation.
Primary Purpose:
Supportive Care
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)
Actual Study Start Date :
Apr 11, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Intervention

Regular follow up by a community based stroke coordinator

Behavioral: 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.

Active Comparator: Control

Usual care

Behavioral: Control
Community based follow-up as usual
Other Names:
  • Usual care
  • Outcome Measures

    Primary Outcome Measures

    1. Modified Rankin Scale (mRS) [18 months]

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

    Secondary Outcome Measures

    1. Modified Rankin Scale (mRS) [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) [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 [6 months]

      ADL function

    4. Barthel Index [12 months]

      ADL function

    5. Barthel Index [18 months]

      ADL function

    6. Nottingham IADL [6 months]

      Extended activities of daily life (ADL) function

    7. Nottingham IADL [12 months]

      Extended activities of daily life (ADL) function

    8. Nottingham IADL [18 months]

      Extended activities of daily life (ADL) function

    9. Stroke Impact Scale (SIS) [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) [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) [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) [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) [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) [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) [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) [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 [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 [6 months]

      Grip strength

    19. Dynamometer [12 months]

      Grip strength

    20. Dynamometer [18 months]

      Grip strength

    21. 6 Minute Walk Test [6 months]

      Endurance. Walking distance during 6 minutes.

    22. 6 Minute Walk Test [12 months]

      Endurance. Walking distance during 6 minutes.

    23. 6 Minute Walk Test [18 months]

      Endurance. Walking distance during 6 minutes.

    24. ActivPAL [6 months]

      Activity monitoring across seven days

    25. ActivPAL [12 months]

      Activity monitoring across seven days

    26. ActivPAL [18 months]

      Activity monitoring across seven days

    27. Montreal Cognitive Assessment [6 months]

      Cognitive function

    28. Montreal Cognitive Assessment [12 months]

      Cognitive function

    29. Montreal Cognitive Assessment [18 months]

      Cognitive function

    30. Trail making test A and B [6 months]

      Executive function

    31. Trail making test A and B [12 months]

      Executive function

    32. Trail making test A and B [18 months]

      Executive function

    33. Global Deterioration Scale (GDS) [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) [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) [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) [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) [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) [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) [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) [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) [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 [6 months]

      A measure of caregivers work participation and absenteeism

    43. Part 2 of the Client Service Receipt Inventory [12 months]

      A measure of caregivers work participation and absenteeism

    44. Part 2 of the Client Service Receipt Inventory [18 months]

      A measure of caregivers work participation and absenteeism

    45. Total cholesterol [6 months]

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

    46. Total cholesterol [12 months]

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

    47. Total cholesterol [18 months]

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

    48. Low Density Lipoprotein (LDL) [6 months]

      The LDL level will be measured by a blood test

    49. Low Density Lipoprotein (LDL) [12 months]

      The LDL level will be measured by a blood test

    50. Low Density Lipoprotein (LDL) [18 months]

      The LDL level will be measured by a blood test

    51. High Density Lipoprotein (HDL) [6 months]

      The HDL level will be measured by a blood test

    52. High Density Lipoprotein (HDL) [12 months]

      The HDL level will be measured by a blood test

    53. High Density Lipoprotein (HDL) [18 months]

      The HDL level will be measured by a blood test

    54. Longterm blood sugar (HbA1c) [6 months]

      The HbA1c level will be measured by a blood test

    55. Longterm blood sugar (HbA1c) [12 months]

      The HbA1c level will be measured by a blood test

    56. Longterm blood sugar (HbA1c) [18 months]

      The HbA1c level will be measured by a blood test

    57. Hemoglobin [6 months]

      The hemoglobin level will be measured by a blood test

    58. Hemoglobin [12 months]

      The hemoglobin level will be measured by a blood test

    59. Hemoglobin [18 months]

      The hemoglobin level will be measured by a blood test

    60. Creatinine [6 months]

      The creatinine level will be measured by a blood test

    61. Creatinine [12 months]

      The creatinine level will be measured by a blood test

    62. Creatinine [18 months]

      The creatinine level will be measured by a blood test

    63. C-reactive protein (CRP) [6 months]

      The CRP level will be measured by a blood test

    64. C-reactive protein (CRP) [12 months]

      The CRP level will be measured by a blood test

    65. C-reactive protein (CRP) [18 months]

      The CRP level will be measured by a blood test

    66. Blood pressure [6 months]

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

    67. Blood pressure [12 months]

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

    68. Blood pressure [18 months]

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

    69. Body mass index (BMI) [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) [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) [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 [18 months]

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

    73. Adherence to the intervention [18 months]

      Number of attended meetings with the stroke coordinator

    74. Exercise Adherence Rating Scale [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 [18 months]

      Adherence to the recommended and agreed activities

    76. Adverse events [18 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • 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).

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Akershus University HospitalLørenskogNorway
    2Vestre Viken Bærum HospitalSandvikaNorway
    3St Olavs Hospital Stroke UnitTrondheimNorway

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • St. Olavs Hospital
    • University Hospital, Akershus
    • Asker & Baerum Hospital

    Investigators

    • Study Director: Jorunn Helbostad, phd prof, Norwegian University for Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT03859063
    Other Study ID Numbers:
    • 2018/1809
    First Posted:
    Mar 1, 2019
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norwegian University of Science and Technology
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021