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

Norwegian University of Science and Technology

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Control; Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03859063

2018/1809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 301 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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301 participants in 2 patient groups

Intervention

Experimental group

Description:

Regular follow up by a community based stroke coordinator

Treatment:

Behavioral: Intervention

Control

Active Comparator group

Description:

Usual care

Treatment:

Behavioral: Control