Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments (NIOTI-stroke)

Emma Ghaziani

Status: Completed

Conditions: Stroke; Cognitive Impairment

Treatments: Other: Impairment-specific occupational therapy (OT) intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05829421

H-22066840

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Impairment-specific occupational therapy (OT) intervention

Experimental group

Description:

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.

Treatment:

Other: Impairment-specific occupational therapy (OT) intervention