Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments

Stroke Clinical Trial

— NIOTI-stroke  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829421
• Other study ID #: H-22066840
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: December 2, 2025

Study information

• Verified date: May 2023
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: Emma Ghaziani, PhD
• Phone: 0045-22787469
• Email: emma.ghaziani[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: December 2, 2025
• Est. primary completion date: May 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Stroke

Intervention

Other:
• Impairment-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.

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg Hospital	Copenhagen
Denmark	Neurorehabilitation Centre Østervang	Frederiksberg
Denmark	the Day Rehabilitation Centre	Frederiksberg
Denmark	the Inpatient Rehabilitation Centre	Frederiksberg

Sponsors (5)

Lead Sponsor	Collaborator
Emma Ghaziani	Neurorehabilitation Centre Østervang, Frederiksberg Municipality, Denmark, Rigshospitalet, Denmark, The Day Rehabilitation Centre, Frederiksberg Municipality, Denmark, The Inpatient Rehabilitation Centre, Frederiksberg Municipality, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Forms collecting feedback from project staff	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. .	Through study completion, an average of 1 year
Other	Work meetings collecting feedback from project staff	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.	Through study completion, an average of 1 year
Other	Semi-structured interviews collecting feedback from patient and caregivers	Based on feedback from patients and caregivers, the investigators will explore the patients' acceptability of the intervention.	Through study completion, an average of 1 year
Primary	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	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
Secondary	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
Secondary	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
Secondary	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