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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Intervention
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two armed parallel group randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Regular follow up by a community based stroke coordinator | Behavioral: Intervention<br>* 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.<br>|
| Active Comparator: Control<br>Usual care | Behavioral: Control<br>* Community based follow-up as usual<br>* Other names: Usual care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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. | 12 months | 
| Barthel Index | ADL function | 6 months | 
| Barthel Index | ADL function | 12 months | 
| Barthel Index | ADL function | 18 months | 
| Nottingham IADL | Extended activities of daily life (ADL) function | 6 months | 
| Nottingham IADL | Extended activities of daily life (ADL) function | 12 months | 
| Nottingham IADL | Extended activities of daily life (ADL) function | 18 months | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | 18 months | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | 18 months | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | 18 months | 
| Dynamometer | Grip strength | 6 months | 
| Dynamometer | Grip strength | 12 months | 
| Dynamometer | Grip strength | 18 months | 
| 6 Minute Walk Test | Endurance. Walking distance during 6 minutes. | 6 months | 
| 6 Minute Walk Test | Endurance. Walking distance during 6 minutes. | 12 months | 
| 6 Minute Walk Test | Endurance. Walking distance during 6 minutes. | 18 months | 
| ActivPAL | Activity monitoring across seven days | 6 months | 
| ActivPAL | Activity monitoring across seven days | 12 months | 
| ActivPAL | Activity monitoring across seven days | 18 months | 
| Montreal Cognitive Assessment | Cognitive function | 6 months | 
| Montreal Cognitive Assessment | Cognitive function | 12 months | 
| Montreal Cognitive Assessment | Cognitive function | 18 months | 
| Trail making test A and B | Executive function | 6 months | 
| Trail making test A and B | Executive function | 12 months | 
| Trail making test A and B | Executive function | 18 months | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | 18 months | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | 18 months | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | 18 months | 
| Part 2 of the Client Service Receipt Inventory | A measure of caregivers work participation and absenteeism | 6 months | 
| Part 2 of the Client Service Receipt Inventory | A measure of caregivers work participation and absenteeism | 12 months | 
| Part 2 of the Client Service Receipt Inventory | A measure of caregivers work participation and absenteeism | 18 months | 
| Total cholesterol | The level of total cholesterol will be measured by a blood test | 6 months | 
| Total cholesterol | The level of total cholesterol will be measured by a blood test | 12 months | 
| Total cholesterol | The level of total cholesterol will be measured by a blood test | 18 months | 
| Low Density Lipoprotein (LDL) | The LDL level will be measured by a blood test | 6 months | 
| Low Density Lipoprotein (LDL) | The LDL level will be measured by a blood test | 12 months | 
| Low Density Lipoprotein (LDL) | The LDL level will be measured by a blood test | 18 months | 
| High Density Lipoprotein (HDL) | The HDL level will be measured by a blood test | 6 months | 
| High Density Lipoprotein (HDL) | The HDL level will be measured by a blood test | 12 months | 
| High Density Lipoprotein (HDL) | The HDL level will be measured by a blood test | 18 months | 
| Longterm blood sugar (HbA1c) | The HbA1c level will be measured by a blood test | 6 months | 
| Longterm blood sugar (HbA1c) | The HbA1c level will be measured by a blood test | 12 months | 
| Longterm blood sugar (HbA1c) | The HbA1c level will be measured by a blood test | 18 months | 
| Hemoglobin | The hemoglobin level will be measured by a blood test | 6 months | 
| Hemoglobin | The hemoglobin level will be measured by a blood test | 12 months | 
| Hemoglobin | The hemoglobin level will be measured by a blood test | 18 months | 
| Creatinine | The creatinine level will be measured by a blood test | 6 months | 
| Creatinine | The creatinine level will be measured by a blood test | 12 months | 
| Creatinine | The creatinine level will be measured by a blood test | 18 months | 
| C-reactive protein (CRP) | The CRP level will be measured by a blood test | 6 months | 
| C-reactive protein (CRP) | The CRP level will be measured by a blood test | 12 months | 
| C-reactive protein (CRP) | The CRP level will be measured by a blood test | 18 months | 
| Blood pressure | Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer | 6 months | 
| Blood pressure | Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer | 12 months | 
| Blood pressure | Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer | 18 months | 
| 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 | 6 months | 
| 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 | 12 months | 
| 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 | 18 months | 
| Health care costs | Data from available registries will be used to estimate costs in Euro | 18 months | 
| Adherence to the intervention | Number of attended meetings with the stroke coordinator | 18 months | 
| 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. | 18 months | 
| Patient diaries | Adherence to the recommended and agreed activities | 18 months | 
| Adverse events | Adverse events will be registered to assess the safety of the intervention. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Cognition, Physical Fitness, Case Managers, Secondary prevention