Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 1057 for:    scale | Norway

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859063
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
University Hospital, Akershus
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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 disease Intervention/treatment Phase
Stroke Behavioral: Intervention Behavioral: Control Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 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 : April 11, 2019
Estimated Primary Completion Date : December 31, 2032
Estimated Study Completion Date : December 31, 2032

Arm Intervention/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 Name: Usual care




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859063


Contacts
Layout table for location contacts
Contact: Torunn Askim, phd prof +47 73412556 torunn.askim@ntnu.no

Locations
Layout table for location information
Norway
Akershus University Hospital Recruiting
Lørenskog, Norway
Contact: Bente Thommessen, PhD       Bente.Thommessen@ahus.no   
Contact: Elin Bergh, MD       Elin.Josefina.Bergh@ahus.no   
St Olavs Hospital Stroke Unit Recruiting
Trondheim, Norway
Contact: Torunn Askim, phd prof       torunn.askim@ntnu.no   
Contact: Anne Hokstad, phd       anne.hokstad@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
University Hospital, Akershus
Investigators
Layout table for investigator information
Study Director: Jorunn Helbostad, phd prof Norwegian University for Science and Technology

Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03859063     History of Changes
Other Study ID Numbers: 2018/1809
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Rehabilitation
Cognition
Physical Fitness
Case Managers
Secondary prevention
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases