Back to resultsCase Studies: Promoting Strategy Use in Functional Activities
Primary Purpose
Cognitive Impairment, Executive Dysfunction, Acquired Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multicontext (MC) approach
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairment
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
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multicontext approach (Intervention) Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Patient satisfaction, as measured by the Patient Satisfaction Questionnaire
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)
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)
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04363645
First Posted
April 23, 2020
Last Updated
April 23, 2020
Sponsor
Weill Medical College of Cornell University
Collaborators
New York Presbyterian Hospital, Mercy College, New York
1. Study Identification
Unique Protocol Identification Number
NCT04363645
Brief Title
Case Studies: Promoting Strategy Use in Functional Activities
Official Title
Case Studies: Promoting Strategy Use in Functional Activities
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 14, 2014 (Actual)
Primary Completion Date
December 29, 2016 (Actual)
Study Completion Date
December 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
New York Presbyterian Hospital, Mercy College, New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Executive Dysfunction, Acquired Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multicontext approach (Intervention) Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multicontext (MC) approach
Intervention Description
The Multicontext approach is a metacognitive intervention designed to improve awareness, strategy use, and executive functioning.
Primary Outcome Measure Information:
Title
Patient satisfaction, as measured by the Patient Satisfaction Questionnaire
Description
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.
Time Frame
End of study (approximately 2 weeks)
Title
Change from baseline in metacognitive skills, as measured by the Self-Regulation Skills Interview (SRSI)
Description
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.
Time Frame
Baseline, end of study (approximately 2 weeks)
Title
Change from baseline in executive functioning, as measured by the Weekly Calendar Planning Activity (WCPA)
Description
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.
Time Frame
Baseline, end of study (approximately 2 weeks)
Title
Change from baseline in disability, as measured by the Functional Independence Measure (FIM)
Description
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.
Time Frame
Baseline, end of study (approximately 2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W O'Dell, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32873157
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.
Results Reference
derived
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Case Studies: Promoting Strategy Use in Functional Activities
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