Case Studies: Promoting Strategy Use in Functional Activities

Not Applicable

Completed

• Conditions: Executive Dysfunction; Acquired Brain Injury; Cognitive Impairment
• Interventions: Other: Multicontext (MC) approach

• Registration Number: NCT04363645
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-14
• Primary Completion: 2016-12-29
• Study Completion: 2016-12-29
• Status Verified: 2020-04
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Last Update Submitted: 2020-04-23
• Study First Posted: 2020-04-27
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multicontext approach (Intervention) Arm	Multicontext (MC) approach	Participants received 30-minute sessions of strategy and self-monitoring practice within the context of everyday activities. These sessions were delivered either daily or twice a day. The total number of sessions varied depending on the participant's length of stay in acute rehabilitation.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction, as measured by the Patient Satisfaction Questionnaire	End of study (approximately 2 weeks)	The Patient Satisfaction Questionnaire consists of open-ended questions of what participants liked most and least about the program, what they would have changed about the program, and any additional suggestions or recommendations. This questionnaire also included Likert-type ratings of their satisfaction, enjoyment, perceived benefit from the intervention, and perceived likelihood of continuing to use the strategies learned in treatment. Patient satisfaction is qualitatively evaluated.
Change from baseline in metacognitive skills, as measured by the Self-Regulation Skills Interview (SRSI)	Baseline, end of study (approximately 2 weeks)	The SRSI is a clinician-administered semi-structured interview that assesses an individual's metacognitive skills and ability to use cognitive strategies. It comprises six questions and each question is scored on a 10-point Likert-type scale. It consists of a total score and three factors, Awareness, Readiness to Change, and Strategy Behavior. The total score ranges from 0 to 60, with lower scores indicating greater metacognitive skills.
Change from baseline in executive functioning, as measured by the Weekly Calendar Planning Activity (WCPA)	Baseline, end of study (approximately 2 weeks)	The WCPA is a standardized, performance-based, ecologically-valid measure of executive functioning in which the participant has to organize a list of appointments into a weekly schedule. The outcome variable is the percentage of appointments entered correctly relative to the total number of appointments entered.
Change from baseline in disability, as measured by the Functional Independence Measure (FIM)	Baseline, end of study (approximately 2 weeks)	The FIM is a standard-of-care measure of disability that assesses the level of assistance required for an individual to perform activities of daily living. The FIM is comprised of 18 items. Each item is rated on a 1-7 scale. The FIM Total scores range from 18 to 126, with higher scores indicating greater functional independence.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States