Case Studies: Promoting Strategy Use in Functional Activities

Cognitive Impairment Clinical Trial

Official title:

Case Studies: Promoting Strategy Use in Functional Activities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363645
• Other study ID #: 1308014257
• Status: Completed
• Phase: N/A
• Start date: December 14, 2014
• Est. completion date: December 29, 2016

Study information

• Verified date: April 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 29, 2016
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cognitive Dysfunction
• Cognitive Impairment
• Executive Dysfunction

Intervention

Other:
• Multicontext (MC) approach
The Multicontext approach is a metacognitive intervention designed to improve awareness, strategy use, and executive functioning.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Mercy College, New York, New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	End of study (approximately 2 weeks)
Primary	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.	Baseline, end of study (approximately 2 weeks)
Primary	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.	Baseline, end of study (approximately 2 weeks)
Primary	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.	Baseline, end of study (approximately 2 weeks)