Cognitive ImpairmentNCT04363645
Case Studies: Promoting Strategy Use in Functional Activities
A study testing Multicontext (MC) approach in people with Cognitive Impairment and Executive Dysfunction, run by Weill Medical College of Cornell University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cognitive Impairment, Executive Dysfunction, Acquired Brain Injury
- What is being tested?
- Multicontext (MC) approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2014to 29 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Cognitively independent in basic self-care activities
- Able to read standard size newsprint
- Ability to demonstrate functional use of at least one hand.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Multicontext (MC) approach
- Medical subject headings
- Cognitive Dysfunction, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicontext (MC) approachOther
The Multicontext approach is a metacognitive intervention designed to improve awareness, strategy use, and executive functioning.
| Study group | Role | What they receive |
|---|---|---|
| Multicontext approach (Intervention) Arm | Experimental | 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. Receives: Other: Multicontext (MC) approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of study (approximately 2 weeks)
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.
Measured: Baseline, end of study (approximately 2 weeks)
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.
Measured: Baseline, end of study (approximately 2 weeks)
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.
Measured: Baseline, end of study (approximately 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start14 Dec 2014
- Primary completion29 Dec 2016
- Study completion29 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Presbyterian Hospital, Mercy University
- Responsible party
- Sponsor
- Investigators
- Michael W O'Dell, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363645
- Sponsor's protocol ID
- 1308014257
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32873157
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Studies: Promoting Strategy Use in Functional Activities
- ClinicalTrials.gov ID
- NCT04363645
- Acronym / sponsor ID
- 1308014257
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- New York Presbyterian Hospital, Mercy University
- Study start
- 14 Dec 2014 (actual)
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicontext approach (Intervention) Arm | Experimental | Other: Multicontext (MC) approachParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicontext (MC) approachThe Multicontext approach is a metacognitive intervention designed to improve awareness, strategy use, and executive functioning. | Other | Multicontext approach (Intervention) Arm |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Derived from this study: PubMed 32873157Jaywant 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W O'Dell, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicontext (MC) approach in people with Cognitive Impairment and Executive Dysfunction, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction, as measured by the Patient Satisfaction Questionnaire (time frame: End of study (approximately 2 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.