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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Intervention; Behavioral: Control

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 Type: Interventional
• Enrollment (Estimated): 301
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Torunn Askim, phd prof; Phone Number: +47 73412556; Email: torunn.askim@ntnu.no

Study Locations

• Norway
  • Lørenskog, Norway
    • Recruiting
    • Akershus University Hospital
    • Contact: Bente Thommessen, PhD; Email: Bente.Thommessen@ahus.no
    • Contact: Elin Bergh, MD; Email: Elin.Josefina.Bergh@ahus.no
  • Sandvika, Norway
    • Recruiting
    • Vestre Viken Bærum Hospital
    • Contact: Håkon Hile-Hansen; Email: HAAIHL@vestreviken.no
  • Trondheim, Norway
    • Recruiting
    • St Olavs Hospital Stroke Unit
    • Contact: Torunn Askim, phd prof; Email: torunn.askim@ntnu.no
    • Contact: Anne Hokstad, phd; Email: anne.hokstad@ntnu.no
  • Ålesund, Norway, 6017
    • Recruiting
    • Alesund Hospital
    • Contact: Møre and Romsdal H Trust
    • Contact: Yngve M Seljeseth; Email: Yngve.Muller.Seljeseth@helse-mr.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Asker & Baerum Hospital; St. Olavs Hospital; Alesund Hospital; University Hospital, Akershus
• Investigators: Study Director: Jorunn Helbostad, phd prof, Norwegian University for Science and Technology

Publications and helpful links

General Publications

• Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Cognition; Secondary prevention; Physical Fitness; Case Managers
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2018/1809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No