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Completed

NCT Number: NCT04363645

Case Studies: Promoting Strategy Use in Functional Activities

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.

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Key information

Conditions

Cognitive Impairment Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Craniocerebral Trauma Executive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multicontext (MC) approach

Other

The Multicontext approach is a metacognitive intervention designed to improve awareness, strategy use, and executive functioning.

Primary outcomes

  1. Patient satisfaction, as measured by the Patient Satisfaction Questionnaire

    Time frame: 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.

  2. Change from baseline in metacognitive skills, as measured by the Self-Regulation Skills Interview (SRSI)

    Time frame: 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.

  3. Change from baseline in executive functioning, as measured by the Weekly Calendar Planning Activity (WCPA)

    Time frame: 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.

  4. Change from baseline in disability, as measured by the Functional Independence Measure (FIM)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Mercy University
  • New York Presbyterian Hospital

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 27, 2020
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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