Clinical trial NCT04363645: Case Studies: Promoting Strategy Use in Functional Activities
Official title: Case Studies: Promoting Strategy Use in Functional Activities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Executive Dysfunction
Acquired Brain Injury
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
name: Mercy University
First posted: 2020-04-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to provide evidence of feasibility, acceptability, patient satisfaction, and patient perceived benefit of the Multicontext (MC) approach. The project consists of eight case studies of persons with acquired brain injury undergoing acute inpatient rehabilitation who have difficulties in completing multiple step activities due to deficits in executive function and/or visual perception. The MC approach provides a structured occupational therapy framework that provides guidelines for enhancing strategy use and self monitoring skills for person's with acquired brain injury.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* English-speaking
* Confirmed diagnosis of acquired brain injury (ABI) based on radiological assessment
* Able to comprehend multistep directions and participate in conversation as assessed by the Functional Independence Measure (FIM; required score of 4 or above on Comprehension and Expression items)
* Impaired performance (\<2 SD below demographically-corrected normative data) on at least one screening measure of executive functioning
* Able to attend to a cognitive task for at least 10 minutes
* Cognitively independent in basic self-care activities
* Able to read standard size newsprint
* Ability to demonstrate functional use of at least one hand.

Exclusion Criteria:

* Global aphasia or moderate - severe comprehension deficits (as indicated by a FIM comprehension score of less than 4)
* Global cognitive impairment or dementia as indicated by a score of 20 or less on the Montreal cognitive assessment
* History of treatment for substance abuse or hospitalizations for psychiatric disorder, within the past year
* non-English speaking

Primary outcomes:
measure: Patient satisfaction, as measured by the Patient Satisfaction Questionnaire
timeFrame: End of study (approximately 2 weeks)
measure: Change from baseline in metacognitive skills, as measured by the Self-Regulation Skills Interview (SRSI)
timeFrame: Baseline, end of study (approximately 2 weeks)
measure: Change from baseline in executive functioning, as measured by the Weekly Calendar Planning Activity (WCPA)
timeFrame: Baseline, end of study (approximately 2 weeks)
measure: Change from baseline in disability, as measured by the Functional Independence Measure (FIM)
timeFrame: Baseline, end of study (approximately 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michael W O'Dell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaywant A, Steinberg C, Lee A, Toglia J. Feasibility and acceptability of the multicontext approach for individuals with acquired brain injury in acute inpatient rehabilitation: A single case series. Neuropsychol Rehabil. 2022 Mar;32(2):211-230. doi: 10.1080/09602011.2020.1810710. Epub 2020 Sep 2.