Clinical trial NCT03859063: Long-term Follow-up After Stroke (The LAST-long Trial)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Cognition
Physical Fitness
Case Managers
Secondary prevention
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University Hospital, Akershus
name: Asker & Baerum Hospital
name: Alesund Hospital
First posted: 2019-03-01
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two armed parallel group randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 18 months
Secondary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 6 months
measure: Modified Rankin Scale (mRS)
timeFrame: 12 months
measure: Barthel Index
timeFrame: 6 months
measure: Barthel Index
timeFrame: 12 months
measure: Barthel Index
timeFrame: 18 months
measure: Nottingham IADL
timeFrame: 6 months
measure: Nottingham IADL
timeFrame: 12 months
measure: Nottingham IADL
timeFrame: 18 months
measure: Stroke Impact Scale (SIS)
timeFrame: 6 months
measure: Stroke Impact Scale (SIS)
timeFrame: 12 months
measure: Stroke Impact Scale (SIS)
timeFrame: 18 months
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: 6 months
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: 12 months
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: 18 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: 6 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: 12 months
measure: Short Physical Performance Battery
timeFrame: 18 months
measure: Dynamometer
timeFrame: 6 months
measure: Dynamometer
timeFrame: 12 months
measure: Dynamometer
timeFrame: 18 months
measure: 6 Minute Walk Test
timeFrame: 6 months
measure: 6 Minute Walk Test
timeFrame: 12 months
measure: 6 Minute Walk Test
timeFrame: 18 months
measure: ActivPAL
timeFrame: 6 months
measure: ActivPAL
timeFrame: 12 months
measure: ActivPAL
timeFrame: 18 months
measure: Montreal Cognitive Assessment
timeFrame: 6 months
measure: Montreal Cognitive Assessment
timeFrame: 12 months
measure: Montreal Cognitive Assessment
timeFrame: 18 months
measure: Trail making test A and B
timeFrame: 6 months
measure: Trail making test A and B
timeFrame: 12 months
measure: Trail making test A and B
timeFrame: 18 months
measure: Global Deterioration Scale (GDS)
timeFrame: 6 months
measure: Global Deterioration Scale (GDS)
timeFrame: 12 months
measure: Global Deterioration Scale (GDS)
timeFrame: 18 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 18 months
measure: Fatigue Severity Scale (FSS-7)
timeFrame: 6 months
measure: Fatigue Severity Scale (FSS-7)
timeFrame: 12 months
measure: Fatigue Severity Scale (FSS-7)
timeFrame: 18 months
measure: Part 2 of the Client Service Receipt Inventory
timeFrame: 6 months
measure: Part 2 of the Client Service Receipt Inventory
timeFrame: 12 months
measure: Part 2 of the Client Service Receipt Inventory
timeFrame: 18 months
measure: Total cholesterol
timeFrame: 6 months
measure: Total cholesterol
timeFrame: 12 months
measure: Total cholesterol
timeFrame: 18 months
measure: Low Density Lipoprotein (LDL)
timeFrame: 6 months
measure: Low Density Lipoprotein (LDL)
timeFrame: 12 months
measure: Low Density Lipoprotein (LDL)
timeFrame: 18 months
measure: High Density Lipoprotein (HDL)
timeFrame: 6 months
measure: High Density Lipoprotein (HDL)
timeFrame: 12 months
measure: High Density Lipoprotein (HDL)
timeFrame: 18 months
measure: Longterm blood sugar (HbA1c)
timeFrame: 6 months
measure: Longterm blood sugar (HbA1c)
timeFrame: 12 months
measure: Longterm blood sugar (HbA1c)
timeFrame: 18 months
measure: Hemoglobin
timeFrame: 6 months
measure: Hemoglobin
timeFrame: 12 months
measure: Hemoglobin
timeFrame: 18 months
measure: Creatinine
timeFrame: 6 months
measure: Creatinine
timeFrame: 12 months
measure: Creatinine
timeFrame: 18 months
measure: C-reactive protein (CRP)
timeFrame: 6 months
measure: C-reactive protein (CRP)
timeFrame: 12 months
measure: C-reactive protein (CRP)
timeFrame: 18 months
measure: Blood pressure
timeFrame: 6 months
measure: Blood pressure
timeFrame: 12 months
measure: Blood pressure
timeFrame: 18 months
measure: Body mass index (BMI)
timeFrame: 6 months
measure: Body mass index (BMI)
timeFrame: 12 months
measure: Body mass index (BMI)
timeFrame: 18 months
measure: Health care costs
timeFrame: 18 months
measure: Adherence to the intervention
timeFrame: 18 months
measure: Exercise Adherence Rating Scale
timeFrame: 18 months
measure: Patient diaries
timeFrame: 18 months
measure: Adverse events
timeFrame: 18 months
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Sandvika
country: Norway
facility: Vestre Viken Bærum Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital Stroke Unit
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
affiliation: Norwegian University for Science and Technology
name: Jorunn Helbostad, phd prof
role: STUDY_DIRECTOR
References:
citation: 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.