search
Back to results

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

Primary Purpose

Cognitive Impairment, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Impairment-specific occupational therapy (OT) intervention
Sponsored by
Emma Ghaziani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring occupational therapy, neuropsychology, stroke rehabilitation, cognitive rehabilitation, activities of daily living (ADL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bispebjerg and Frederiksberg HospitalRecruiting
  • Neurorehabilitation Centre Østervang
  • the Day Rehabilitation Centre
  • the Inpatient Rehabilitation Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Impairment-specific occupational therapy (OT) intervention

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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

Full Information

First Posted
March 6, 2023
Last Updated
July 24, 2023
Sponsor
Emma Ghaziani
Collaborators
Rigshospitalet, Denmark, The Day Rehabilitation Centre, Frederiksberg Municipality, Denmark, The Inpatient Rehabilitation Centre, Frederiksberg Municipality, Denmark, Neurorehabilitation Centre Østervang, Frederiksberg Municipality, Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT05829421
Brief Title
Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
May 2, 2025 (Anticipated)
Study Completion Date
December 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emma Ghaziani
Collaborators
Rigshospitalet, Denmark, The Day Rehabilitation Centre, Frederiksberg Municipality, Denmark, The Inpatient Rehabilitation Centre, Frederiksberg Municipality, Denmark, Neurorehabilitation Centre Østervang, Frederiksberg Municipality, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Stroke
Keywords
occupational therapy, neuropsychology, stroke rehabilitation, cognitive rehabilitation, activities of daily living (ADL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Impairment-specific occupational therapy (OT) intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Impairment-specific occupational therapy (OT) intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in ADL process skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke
Description
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.
Time Frame
At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
Secondary Outcome Measure Information:
Title
Change from baseline in ADL motor skills level (assessed by the Assessment of Motor and Process Skills, AMPS) at 3 months poststroke
Description
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.
Time Frame
At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
Title
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)
Description
Stroke-specific measure of global disability. Min-max values: 0 (no symptoms at all9 - 6 (dead).
Time Frame
At baseline (as soon as possible after stroke onset - expected:1 week poststroke) and 3 months poststroke
Title
Patient perceived health-related quality of life (assessed by the EuroQol-5D-5L, EQ-5D-5L) at 3 months poststroke
Description
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.
Time Frame
At 3 months poststroke
Title
Caregiver perceived burden of stroke (assessed by the Caregiver Burden Scale, CBS) at 3 months posttsroke.
Description
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
Time Frame
At 3 months poststroke
Other Pre-specified Outcome Measures:
Title
Forms collecting feedback from project staff
Description
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. .
Time Frame
Through study completion, an average of 1 year
Title
Work meetings collecting feedback from project staff
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Semi-structured interviews collecting feedback from patient and caregivers
Description
Based on feedback from patients and caregivers, the investigators will explore the patients' acceptability of the intervention.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Ghaziani, PhD
Phone
0045-22787469
Email
emma.ghaziani@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne Christensen, Professor
Phone
0045-38635070
Email
hanne.krarup.christensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Christensen, Professor
Organizational Affiliation
Bispebjerg and Frederiksberg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg and Frederiksberg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Arens, MSc
Phone
0045-71724304
Email
christian.hedelund.arens@regionh.dk
First Name & Middle Initial & Last Name & Degree
Sun-Hee Christensen, MSc
Phone
00045-38635108
Email
sun-hee.skovgaard.christensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Hanne Christensen, Professor
First Name & Middle Initial & Last Name & Degree
Christian Arens, MSc
First Name & Middle Initial & Last Name & Degree
Sun-Hee Christensen, MSc
First Name & Middle Initial & Last Name & Degree
Hana Rytter, PhD
Facility Name
Neurorehabilitation Centre Østervang
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
the Day Rehabilitation Centre
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
the Inpatient Rehabilitation Centre
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Addressing Problems in Managing Daily Tasks Due to Poststroke Cognitive Impairments

We'll reach out to this number within 24 hrs