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

Stroke Clinical Trial

— LAST-long  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03859063
• Other study ID #: 2018/1809
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: Norwegian University of Science and Technology
• Contact: Torunn Askim, phd prof
• Phone: +47 73412556
• Email: torunn.askim[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 301
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Control
Community based follow-up as usual

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Akershus University Hospital	Lørenskog
Norway	Vestre Viken Bærum Hospital	Sandvika
Norway	St Olavs Hospital Stroke Unit	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Alesund Hospital, Asker & Baerum Hospital, St. Olavs Hospital, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

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