Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments

Study Overview
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Brief Summary
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The purpose of this study is to investigate feasibility aspects of an intervention targeting problems in managing daily tasks due to mild-to-moderate poststroke cognitive impairments. We will specifically address uncertainties related to intervention content and delivery, and trial design and conduct.

Official Title
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Feasibility of a Neuropsychologically Informed Occupational Therapy Intervention Targeting Decreased Ability to Perform Activities of Daily Living in People With Poststroke Cognitive Impairment

Conditions
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Cognitive Impairment, Stroke

Intervention / Treatment
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* Other: Impairment-specific occupational therapy (OT) intervention


Participation Criteria
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Eligibility Criteria
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PATIENTS: Inclusion criteria: first-ever symptomatic stroke, age ≥ 18 years, residence in Frederiksberg Municipality, Denmark, independent in pre-stroke everyday life (≤ 2 points on the modified Rankin Scale, mRS), experiencing problems in performing ADLs due to cognitive impairment; these problems are expected to still be present at hospital discharge, medical condition allows commencement of rehabilitation focused on ADL and cognition fully aware or mild-to-moderate unawareness of deficits (≤ 2 points on the Bisiach Anosognosia Scale, BAS), a global cognitive function corresponding to ≥ 17 points on the Montreal Cognitive Assessment, MoCA, ≤ 10 points on the depression subscale of the Hospital Anxiety and Depression Scale, HADS, able to provide informed consent, as evaluated by the recruiting healthcare professional(s), logistically possible to perform baseline assessments and create an individualised intervention plan during hospital stay provides informed consent Exclusion criteria: psychiatric conditions causing difficulties or preventing participation, as evaluated by the recruiting health care professional(s) communication problems causing difficulties or preventing participation, as evaluated by the recruiting healthcare professional(s) CAREGIVERS: Inclusion criteria: appointed as close carer (by a patient who consented to participate), age ≥18y, provides informed consent. Exclusion criteria: -communication problems or other issues causing difficulties in participation as evaluated by the recruiting healthcare professional(s). Patients without a close carer will not be excluded. CLINICAL STAFF: Inclusion criteria: appointed as local project managers, or OTs or NPs who conduct assessments or deliver the intervention in the participating centres, provides informed consent. Exclusion criteria: - unable to to follow a preliminary English version of the intervention manual.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study, non-randomised. An adaptive approach will be used to optimise the intervention content and study conduct as feasibility data are cumulated
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impairment-specific occupational therapy (OT) intervention<br>Patients receive an impairment-specific OT intervention targetting problems in managing activities of daily living (ADL) due to mild-to-moderate poststroke cognitive impairments. The intervention is initiated in the stroke unit as soon as patients' medical condition allows it, and it is delivered 3 times per week until 3 months poststroke. After hospital discharge, the intervention continues in community settings. | Other: Impairment-specific occupational therapy (OT) intervention<br>* In parallel with standard practice, patients receive an OT intervention adapted to the specific underlying cognitive impairments that are likely to disturb their performance of ADLs. The intervention is individualised through a 3-step process: a) a list of dysfunctional ADL process skills is forwarded by the OT to the neuropsychologist (NP), b) the NP identifies the cognitive impairments which are most likely to cause the dysfunctional ADL process skills through a cognitive assessment, c) based on the identified cognitive impairments, the NP and the OT select in collaboration the cognitive strategies that are most likely to benefit the individual patient from a pre-prepared intervention manual. Because of the large heterogeneity in how cognitive impairments impact on ADL performance, the exact way of implementing the selected cognitive strategies into the practice of the individual patient is left to the OT´s clinical judgement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke | The AMPS is a standardised observation-based instrument measuring two aspects of ADL performance: ADL motor skills (reflecting physical effort) and ADL process skills (reflecting efficiency, safety, and independence). The quality of each skill is evaluated on a 4-level scale. Based on Rasch statistics, the AMPS software converts these raw scores into two overall linear ADL scores (expressed in logits): an ADL motor score, and an ADL process score. Several studies support the AMPS' validity and reliability in both stroke populations. The AMPS is an OT-specific instrument and requires user certification. | At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ADL motor skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke | The AMPS is a standardised observation-based instrument measuring two aspects of ADL performance: ADL motor skills (reflecting physical effort) and ADL process skills (reflecting efficiency, safety, and independence). The quality of each skill is evaluated on a 4-level scale. Based on Rasch statistics, the AMPS software converts these raw scores into two overall linear ADL scores (expressed in logits): an ADL motor score, and an ADL process score. Several studies support the AMPS' validity and reliability in both stroke populations. The AMPS is an OT-specific instrument and requires user certification. | At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke | 
| Change from pre-stroke in global disability (assessed by the modified Rankin Scale, mRS) at 3 months. Min-max values: 0 (no symptoms at all) - 6 (dead) | Stroke-specific measure of global disability. Min-max values: 0 (no symptoms at all9 - 6 (dead). | At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke | 
| Patient perceived health-related quality of life (assessed by the EuroQol-5D-5L, EQ-5D-5L) at 3 months poststroke | Generic measure of health-related quality of life. It contains six subscales: mobility, self-care, usual activities, pain/discomfort, anxiety depression and perceived health. Perceived health is measured on a 0-100 scale (0: worst outcome, 100: best outcome). Each of remaining subscales are scored on a 5-level ordinal scale (1: best outcome, 5: worse outcome). The result for each subscale will be presented separately. | At 3 months poststroke | 
| Caregiver perceived burden of stroke (assessed by the Caregiver Burden Scale, CBS) at 3 months posttsroke. | The CBS is a 22-item scale that assess subjectively experienced burden by caregiver's to chronically disabled persons. The caregiver is asked to tick one of the four boxes (not at all, seldom, sometimes, often) score 1 to 4 for each question. The instrument comprises five factors: general strain, isolation, disappointment, emotional involvement and environment. A mean value is calculated for each factor including the following items: General strain: 1, 3, 4, 5, 7, 10, 14, and 19 Isolation: 8, 12, and 22 Disappointment: 2, 13, 18, 20, and 21 Emotional involvement: 6, 11, and 16 Environment: 9, 15, and 17 | At 3 months poststroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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occupational therapy, neuropsychology, stroke rehabilitation, cognitive rehabilitation, activities of daily living (ADL)