Clinical trial NCT05829421: Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Stroke
Keywords: occupational therapy
neuropsychology
stroke rehabilitation
cognitive rehabilitation
activities of daily living (ADL)
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: The Day Rehabilitation Centre, Frederiksberg Municipality, Denmark
name: The Inpatient Rehabilitation Centre, Frederiksberg Municipality, Denmark
name: Neurorehabilitation Centre Østervang, Frederiksberg Municipality, Denmark
First posted: 2023-04-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.


Eligibility 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.

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.

Primary outcomes:
measure: Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke
timeFrame: At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
Secondary outcomes:
measure: Change from baseline in ADL motor skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke
timeFrame: At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
measure: 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)
timeFrame: At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
measure: Patient perceived health-related quality of life (assessed by the EuroQol-5D-5L, EQ-5D-5L) at 3 months poststroke
timeFrame: At 3 months poststroke
measure: Caregiver perceived burden of stroke (assessed by the Caregiver Burden Scale, CBS) at 3 months posttsroke.
timeFrame: At 3 months poststroke
Other outcomes:
measure: Forms collecting feedback from project staff
timeFrame: Through study completion, an average of 1 year
measure: Work meetings collecting feedback from project staff
timeFrame: Through study completion, an average of 1 year
measure: Semi-structured interviews collecting feedback from patient and caregivers
timeFrame: Through study completion, an average of 1 year
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital
city: Frederiksberg
country: Denmark
facility: Neurorehabilitation Centre Østervang
city: Frederiksberg
country: Denmark
facility: the Day Rehabilitation Centre
city: Frederiksberg
country: Denmark
facility: the Inpatient Rehabilitation Centre
Study officials:
affiliation: Bispebjerg and Frederiksberg Hospital
name: Hanne Christensen, Professor
role: PRINCIPAL_INVESTIGATOR
References: