Improving daily task management for stroke survivors with cognitive impairments
Feasibility of a Neuropsychologically Informed Occupational Therapy Intervention Targeting Decreased Ability to Perform Activities of Daily Living in People With Poststroke Cognitive Impairment
This study is trying out a new occupational therapy program to help stroke survivors with mild-to-moderate cognitive challenges manage their daily activities better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 4 sites (Copenhagen and 3 other locations) |
| Trial ID | NCT05829421 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of an occupational therapy intervention aimed at helping individuals with mild-to-moderate cognitive impairments following their first-ever stroke. The focus is on addressing challenges in managing daily activities due to cognitive deficits. The study will explore various aspects of intervention content, delivery, and overall trial design to ensure effective rehabilitation. Participants will receive tailored support to enhance their ability to perform activities of daily living (ADLs).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced their first-ever symptomatic stroke and are facing cognitive challenges that affect their daily living activities.
Not a fit: Patients with severe cognitive impairments or those who are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for stroke survivors by enhancing their ability to manage daily tasks.
How similar studies have performed: Previous studies have shown promise in using occupational therapy for cognitive rehabilitation post-stroke, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Copenhagen and 3 other locations
- Bispebjerg and Frederiksberg Hospital — Copenhagen, Denmark (Recruiting)
- Neurorehabilitation Centre Østervang — Frederiksberg, Denmark (Active_not_recruiting)
- the Day Rehabilitation Centre — Frederiksberg, Denmark (Active_not_recruiting)
- the Inpatient Rehabilitation Centre — Frederiksberg, Denmark (Active_not_recruiting)
Study contacts
- Principal investigator: Hanne Christensen, Professor — Bispebjerg and Frederiksberg Hospital
- Study coordinator: Emma Ghaziani, PhD
- Email: emma.ghaziani@regionh.dk
- Phone: 0045-22787469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.