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

Locations

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 Disease	Intervention/Treatment	Phase
Stroke	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

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 Names: Usual care

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 Names:

Usual care

Outcome Measures

Primary Outcome Measures

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

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

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).