Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments

NCT ID: NCT05829421

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2025-10-01

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.

Conditions

Cognitive Impairment; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Impairment-specific occupational therapy (OT) intervention

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.

Group Type: EXPERIMENTAL

Impairment-specific occupational therapy (OT) intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• appointed as close carer (by a patient who consented to participate),
• age ≥18y,
• provides informed consent.

• 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

• 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:

-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:

• unable to to follow a preliminary English version of the intervention manual.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

The Day Rehabilitation Centre, Frederiksberg Municipality, Denmark

UNKNOWN

Sponsor Role: collaborator

The Inpatient Rehabilitation Centre, Frederiksberg Municipality, Denmark

UNKNOWN

Sponsor Role: collaborator

Neurorehabilitation Centre Østervang, Frederiksberg Municipality, Denmark

UNKNOWN

Sponsor Role: collaborator

Emma Ghaziani

OTHER

Sponsor Role: lead

Responsible Party

Emma Ghaziani

Postdoc, OT

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hanne Christensen, Professor

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg and Frederiksberg Hospital

Locations

Bispebjerg and Frederiksberg Hospital

Copenhagen, , Denmark

Neurorehabilitation Centre Østervang

Frederiksberg, , Denmark

the Day Rehabilitation Centre

Frederiksberg, , Denmark

the Inpatient Rehabilitation Centre

Frederiksberg, , Denmark

Countries

Denmark

Other Identifiers

H-22066840

Identifier Type: -

Identifier Source: org_study_id