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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

Tracking Information
First Submitted Date  ICMJE February 11, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE April 11, 2019
Estimated Primary Completion Date December 31, 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03859063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • 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.
  • 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.
  • Barthel Index [ Time Frame: 6 months ]
    ADL function
  • Barthel Index [ Time Frame: 12 months ]
    ADL function
  • Barthel Index [ Time Frame: 18 months ]
    ADL function
  • Nottingham IADL [ Time Frame: 6 months ]
    Extended activities of daily life (ADL) function
  • Nottingham IADL [ Time Frame: 12 months ]
    Extended activities of daily life (ADL) function
  • Nottingham IADL [ Time Frame: 18 months ]
    Extended activities of daily life (ADL) function
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Dynamometer [ Time Frame: 6 months ]
    Grip strength
  • Dynamometer [ Time Frame: 12 months ]
    Grip strength
  • Dynamometer [ Time Frame: 18 months ]
    Grip strength
  • 6 Minute Walk Test [ Time Frame: 6 months ]
    Endurance. Walking distance during 6 minutes.
  • 6 Minute Walk Test [ Time Frame: 12 months ]
    Endurance. Walking distance during 6 minutes.
  • 6 Minute Walk Test [ Time Frame: 18 months ]
    Endurance. Walking distance during 6 minutes.
  • ActivPAL [ Time Frame: 6 months ]
    Activity monitoring across seven days
  • ActivPAL [ Time Frame: 12 months ]
    Activity monitoring across seven days
  • ActivPAL [ Time Frame: 18 months ]
    Activity monitoring across seven days
  • Montreal Cognitive Assessment [ Time Frame: 6 months ]
    Cognitive function
  • Montreal Cognitive Assessment [ Time Frame: 12 months ]
    Cognitive function
  • Montreal Cognitive Assessment [ Time Frame: 18 months ]
    Cognitive function
  • Trail making test A and B [ Time Frame: 6 months ]
    Executive function
  • Trail making test A and B [ Time Frame: 12 months ]
    Executive function
  • Trail making test A and B [ Time Frame: 18 months ]
    Executive function
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Part 2 of the Client Service Receipt Inventory [ Time Frame: 6 months ]
    A measure of caregivers work participation and absenteeism
  • Part 2 of the Client Service Receipt Inventory [ Time Frame: 12 months ]
    A measure of caregivers work participation and absenteeism
  • Part 2 of the Client Service Receipt Inventory [ Time Frame: 18 months ]
    A measure of caregivers work participation and absenteeism
  • Total cholesterol [ Time Frame: 6 months ]
    The level of total cholesterol will be measured by a blood test
  • Total cholesterol [ Time Frame: 12 months ]
    The level of total cholesterol will be measured by a blood test
  • Total cholesterol [ Time Frame: 18 months ]
    The level of total cholesterol will be measured by a blood test
  • Low Density Lipoprotein (LDL) [ Time Frame: 6 months ]
    The LDL level will be measured by a blood test
  • Low Density Lipoprotein (LDL) [ Time Frame: 12 months ]
    The LDL level will be measured by a blood test
  • Low Density Lipoprotein (LDL) [ Time Frame: 18 months ]
    The LDL level will be measured by a blood test
  • High Density Lipoprotein (HDL) [ Time Frame: 6 months ]
    The HDL level will be measured by a blood test
  • High Density Lipoprotein (HDL) [ Time Frame: 12 months ]
    The HDL level will be measured by a blood test
  • High Density Lipoprotein (HDL) [ Time Frame: 18 months ]
    The HDL level will be measured by a blood test
  • Longterm blood sugar (HbA1c) [ Time Frame: 6 months ]
    The HbA1c level will be measured by a blood test
  • Longterm blood sugar (HbA1c) [ Time Frame: 12 months ]
    The HbA1c level will be measured by a blood test
  • Longterm blood sugar (HbA1c) [ Time Frame: 18 months ]
    The HbA1c level will be measured by a blood test
  • Hemoglobin [ Time Frame: 6 months ]
    The hemoglobin level will be measured by a blood test
  • Hemoglobin [ Time Frame: 12 months ]
    The hemoglobin level will be measured by a blood test
  • Hemoglobin [ Time Frame: 18 months ]
    The hemoglobin level will be measured by a blood test
  • Creatinine [ Time Frame: 6 months ]
    The creatinine level will be measured by a blood test
  • Creatinine [ Time Frame: 12 months ]
    The creatinine level will be measured by a blood test
  • Creatinine [ Time Frame: 18 months ]
    The creatinine level will be measured by a blood test
  • C-reactive protein (CRP) [ Time Frame: 6 months ]
    The CRP level will be measured by a blood test
  • C-reactive protein (CRP) [ Time Frame: 12 months ]
    The CRP level will be measured by a blood test
  • C-reactive protein (CRP) [ Time Frame: 18 months ]
    The CRP level will be measured by a blood test
  • Blood pressure [ Time Frame: 6 months ]
    Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer
  • Blood pressure [ Time Frame: 12 months ]
    Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer
  • Blood pressure [ Time Frame: 18 months ]
    Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer
  • 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
  • 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
  • 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
  • Health care costs [ Time Frame: 18 months ]
    Data from available registries will be used to estimate costs in Euro
  • Adherence to the intervention [ Time Frame: 18 months ]
    Number of attended meetings with the stroke coordinator
  • 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.
  • Patient diaries [ Time Frame: 18 months ]
    Adherence to the recommended and agreed activities
  • Adverse events [ Time Frame: 18 months ]
    Adverse events will be registered to assess the safety of the intervention.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Follow-up After Stroke (The LAST-long Trial)
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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.
  • Behavioral: Control
    Community based follow-up as usual
    Other Name: Usual care
Study Arms  ICMJE
  • Experimental: Intervention
    Regular follow up by a community based stroke coordinator
    Intervention: Behavioral: Intervention
  • Active Comparator: Control
    Usual care
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2019)
490
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2032
Estimated Primary Completion Date December 31, 2032   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Torunn Askim, phd prof +47 73412556 torunn.askim@ntnu.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03859063
Other Study ID Numbers  ICMJE 2018/1809
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • St. Olavs Hospital
  • University Hospital, Akershus
Investigators  ICMJE
Study Director: Jorunn Helbostad, phd prof Norwegian University for Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP