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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
301
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.
Community based follow-up as usual
Ålesund Hospital
Ålesund, Norway
Akershus University Hospital
Lørenskog, Norway
Vestre Viken Bærum Hospital
Sandvika, Norway
St Olavs Hospital Stroke Unit
Trondheim, Norway
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.
Time frame: 18 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.
Time frame: 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.
Time frame: 12 months
Barthel Index
ADL function
Time frame: 6 months
Barthel Index
ADL function
Time frame: 12 months
Barthel Index
ADL function
Time frame: 18 months
Nottingham IADL
Extended activities of daily life (ADL) function
Time frame: 6 months
Nottingham IADL
Extended activities of daily life (ADL) function
Time frame: 12 months
Nottingham IADL
Extended activities of daily life (ADL) function
Time frame: 18 months
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
Dynamometer
Grip strength
Time frame: 6 months
Dynamometer
Grip strength
Time frame: 12 months
Dynamometer
Grip strength
Time frame: 18 months
6 Minute Walk Test
Endurance. Walking distance during 6 minutes.
Time frame: 6 months
6 Minute Walk Test
Endurance. Walking distance during 6 minutes.
Time frame: 12 months
6 Minute Walk Test
Endurance. Walking distance during 6 minutes.
Time frame: 18 months
ActivPAL
Activity monitoring across seven days
Time frame: 6 months
ActivPAL
Activity monitoring across seven days
Time frame: 12 months
ActivPAL
Activity monitoring across seven days
Time frame: 18 months
Montreal Cognitive Assessment
Cognitive function
Time frame: 6 months
Montreal Cognitive Assessment
Cognitive function
Time frame: 12 months
Montreal Cognitive Assessment
Cognitive function
Time frame: 18 months
Trail making test A and B
Executive function
Time frame: 6 months
Trail making test A and B
Executive function
Time frame: 12 months
Trail making test A and B
Executive function
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
Part 2 of the Client Service Receipt Inventory
A measure of caregivers work participation and absenteeism
Time frame: 6 months
Part 2 of the Client Service Receipt Inventory
A measure of caregivers work participation and absenteeism
Time frame: 12 months
Part 2 of the Client Service Receipt Inventory
A measure of caregivers work participation and absenteeism
Time frame: 18 months
Total cholesterol
The level of total cholesterol will be measured by a blood test
Time frame: 6 months
Total cholesterol
The level of total cholesterol will be measured by a blood test
Time frame: 12 months
Total cholesterol
The level of total cholesterol will be measured by a blood test
Time frame: 18 months
Low Density Lipoprotein (LDL)
The LDL level will be measured by a blood test
Time frame: 6 months
Low Density Lipoprotein (LDL)
The LDL level will be measured by a blood test
Time frame: 12 months
Low Density Lipoprotein (LDL)
The LDL level will be measured by a blood test
Time frame: 18 months
High Density Lipoprotein (HDL)
The HDL level will be measured by a blood test
Time frame: 6 months
High Density Lipoprotein (HDL)
The HDL level will be measured by a blood test
Time frame: 12 months
High Density Lipoprotein (HDL)
The HDL level will be measured by a blood test
Time frame: 18 months
Longterm blood sugar (HbA1c)
The HbA1c level will be measured by a blood test
Time frame: 6 months
Longterm blood sugar (HbA1c)
The HbA1c level will be measured by a blood test
Time frame: 12 months
Longterm blood sugar (HbA1c)
The HbA1c level will be measured by a blood test
Time frame: 18 months
Hemoglobin
The hemoglobin level will be measured by a blood test
Time frame: 6 months
Hemoglobin
The hemoglobin level will be measured by a blood test
Time frame: 12 months
Hemoglobin
The hemoglobin level will be measured by a blood test
Time frame: 18 months
Creatinine
The creatinine level will be measured by a blood test
Time frame: 6 months
Creatinine
The creatinine level will be measured by a blood test
Time frame: 12 months
Creatinine
The creatinine level will be measured by a blood test
Time frame: 18 months
C-reactive protein (CRP)
The CRP level will be measured by a blood test
Time frame: 6 months
C-reactive protein (CRP)
The CRP level will be measured by a blood test
Time frame: 12 months
C-reactive protein (CRP)
The CRP level will be measured by a blood test
Time frame: 18 months
Blood pressure
Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer
Time frame: 6 months
Blood pressure
Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer
Time frame: 12 months
Blood pressure
Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 18 months
Health care costs
Data from available registries will be used to estimate costs in Euro
Time frame: 18 months
Adherence to the intervention
Number of attended meetings with the stroke coordinator
Time frame: 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.
Time frame: 18 months
Patient diaries
Adherence to the recommended and agreed activities
Time frame: 18 months
Adverse events
Adverse events will be registered to assess the safety of the intervention.
Time frame: 18 months