Long-term Follow-up After Stroke (The LAST-long Trial)
- Conditions
- Stroke
- Interventions
- Behavioral: ControlBehavioral: Intervention
- Registration Number
- NCT03859063
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 301
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Usual care Intervention Intervention Regular follow up by a community based stroke coordinator
- Primary Outcome Measures
Name Time Method 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
Name Time Method Total cholesterol 18 months The level of total cholesterol will be measured by a blood test
Barthel Index 18 months ADL 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 18 months Grip strength
6 Minute Walk Test 18 months Endurance. Walking distance during 6 minutes.
ActivPAL 18 months Activity monitoring across seven days
Nottingham IADL 18 months Extended activities of daily life (ADL) function
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.
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.
Part 2 of the Client Service Receipt Inventory 18 months A measure of caregivers work participation and absenteeism
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.
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.
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
Adverse events 18 months Adverse events will be registered to assess the safety of the intervention.
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.
Montreal Cognitive Assessment 18 months Cognitive function
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.
Low Density Lipoprotein (LDL) 18 months The LDL 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) 18 months The HbA1c level will be measured by a blood test
Hemoglobin 18 months The hemoglobin level will be measured by a blood test
Health care costs 18 months Data from available registries will be used to estimate costs in Euro
Patient diaries 18 months Adherence to the recommended and agreed activities
Trail making test A and B 18 months Executive function
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.
Creatinine 18 months The creatinine level will be measured by a blood test
Blood pressure 18 months Systolic and diastolic blood pressure will be measured by use of a sphygmomanometer
Adherence to the intervention 18 months Number of attended meetings with the stroke coordinator
C-reactive protein (CRP) 18 months The CRP level will be measured by a blood test
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.
Trial Locations
- Locations (4)
St Olavs Hospital Stroke Unit
🇳🇴Trondheim, Norway
Vestre Viken Bærum Hospital
🇳🇴Sandvika, Norway
Ålesund Hospital
🇳🇴Ålesund, Norway
Akershus University Hospital
🇳🇴Lørenskog, Norway