Cognitive Impairment, Stroke
Conditions
Keywords
occupational therapy, neuropsychology, stroke rehabilitation, cognitive rehabilitation, activities of daily living (ADL)
Brief summary
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.
Interventions
OTHERImpairment-specific occupational therapy (OT) intervention
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.
Sponsors
Rigshospitalet, Denmark
The Day Rehabilitation Centre, Frederiksberg Municipality, Denmark
The Inpatient Rehabilitation Centre, Frederiksberg Municipality, Denmark
Neurorehabilitation Centre Østervang, Frederiksberg Municipality, Denmark
Emma Ghaziani
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke | At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver perceived burden of stroke (assessed by the Caregiver Burden Scale, CBS) at 3 months posttsroke. | At 3 months poststroke | 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 |
| Change from baseline in ADL motor skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke | At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 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. |
| 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) | At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke | Stroke-specific measure of global disability. Min-max values: 0 (no symptoms at all9 - 6 (dead). |
| Patient perceived health-related quality of life (assessed by the EuroQol-5D-5L, EQ-5D-5L) at 3 months poststroke | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Semi-structured interviews collecting feedback from patient and caregivers | Through study completion, an average of 1 year | Based on feedback from patients and caregivers, the investigators will explore the patients' acceptability of the intervention. |
| Work meetings collecting feedback from project staff | Through study completion, an average of 1 year | Based on feedback from the project staff collected through work meetings, the investigators will explore feasibility aspects such as: OTs' acceptability of the intervention, piloting the individualisation of the intervention, piloting the intervention delivery, and refining the intervention manual. |
| Forms collecting feedback from project staff | Through study completion, an average of 1 year | Based on feedback from the project staff collected through forms, the investigators will explore feasibility aspects such as: OTs' acceptability of the intervention, piloting the individualisation of the intervention, piloting the intervention delivery, refining the intervention manual, estimating participant recruitment and retention for a future RCT, and piloting outcome measures. . |
Countries
Denmark
Outcome results
None listed