Peer Review, ResearchExecutiveNCT02411734
Effect of Executive Dysfunction on Rehabilitation Potential
An observational study of Peer Review, Research, run by University of South Florida.
Trial summary
Executive function will be tested in patients admitted for rehabilitation and correlated with rehabilitation success Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Peer Review, Research
- What is being tested?
- Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Mar 2016
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted for rehabilitation after a hospitalization
Who may be able to join
- Speaking English
Who cannot join
- None
About this study
Executive function will be tested in patients admitted for rehabilitation and correlated with rehabilitation success
Read the detailed description
- Rationale: Many patients who were hospitalized benefit from rehabilitation after they are discharged. Rehabilitation may be provided in one of several settings, including home, nursing home or facility specializing in rehabilitation. Success of rehabilitation depends on patient's ability and willingness to cooperate with rehabilitation staff. Unfortunately, some patients cannot or do not follow the rehabilitation protocol. If they do not participate in rehabilitation for at least 90 minutes/day, they have to be discharged from a rehabilitation facility. It would be useful to be able to predict which patients will have problem with rehabilitation after they are admitted from an acute care setting. In this study, the investigators will test the hypothesis that executive function is important for achieving rehabilitation goals.
- Background: Executive function is a set of mental processes that helps connect past experience with present action. People use it to perform activities such as planning, organizing, strategizing, paying attention to and remembering details, and managing time and space. Executive function was the most important factor for level of care elderly individuals required (Royall, Chiodo, \& Polk, 2005). This study also found that many elderly individuals have impaired executive function even though they have normal cognitive function. Executive function is also related to functional abilities in individuals with mild dementia (Martyr \& Clare, 2012).
- The research question: The hypothesis tested in this study is that rehabilitation potential is decreased in persons with impaired executive function. The purpose of this study is to attempt development of a screening tool that could be used before the patients are admitted for rehabilitation. Results of this screening would alert the rehabilitation facility about possible problems occurring after the patient is admitted for rehabilitation. If such a testing will show that patient's executive function is impaired, rehabilitation results may be improved by treatment of this impairment (Royall et al., 2009).
- Study design: During admission of a patient, Dennise Fernandez will ask patients to state why they need rehabilitation. If they are able to state the reason, Dennise Fernandez will explained the study to them and if the patient is interested she will give him/her the Informed Consent Form. If the patient will be unable to state the reason for rehabilitation, the study will be explained to his/her proxy and informed consent given to the proxy. The patient/proxy will have time to read the Informed Consent on his/her own and ask any questions he/she may have. It the patient/proxy signs the Informed Consent, Dennise Fernandez will ask how old the patient is and the patient will be asked to complete the Trail Making Tests. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Errors affect the patient's score only in that the correction of errors is included in the completion time for the task. It is unnecessary to continue the test if the patient has not completed both parts after five minutes have elapsed. Step 1: Give the patient a copy of the Trail Making Test Part A worksheet and a pen or pencil. Step 2: Demonstrate the test to the patient using the sample sheet (Trail Making Part A - SAMPLE). Step 3: Time the patient as he or she follows the "trail" made by the numbers on the test. Step 4: Record the time. Step 5: Repeat the procedure for Trail Making Test Part B. Scoring: Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The patient will participate in therapy during their stay, with their participation evaluated by a) amount of time participating in therapy each day, b) need for encouragement by staff to participate. Encouragement will be rated on four point scale: i) no encouragement, ii) minimal encouragement, iii) moderate encouragement, iv) maximum encouragement. 72 hours prior to discharge, they will be asked by Dennise Fernandez to complete again Trail Making Tests.
- Sample size: 100 patients
- Study population: All admitted patients who will meet inclusion criteria will be approached until 100 of them signs the Informed Consent Form. Inclusion criteria:
- Admitted for rehabilitation
- 65 years old or older
- Speaks English Exclusion criteria:
- Unable to read (even with glasses)
- Unable to write
- The expected results of the research: Results of this study will be published in a scientific journal. If the results are positive, a scale will be developed that will inform rehabilitation facility about rehabilitation potential of a patient before he/she is admitted for rehabilitation.
- Principal Investigator: Ladislav Volicer, MD, PhD
- Potential risk to the subjects: The research will not influence rehabilitation of the patients. The only risk is that they may become frustrated if they difficulty accomplishing the Trail Making Tests.
- Experimental Procedures: Administration of the Trail Making Tests and recording duration of rehabilitation and possible need for encouragement. Results of Trail Making Test with be correlated with level of participation in therapy.
- Potential benefit to subjects: None
- Human subjects considerations: Informed consent will be given to patients only after they express interest in research and they will have one day to decide if they want to sign it. If a patient cannot explain the reason for his/rehabilitation, the study will be explained to his/her proxy and the proxy will receive the informed consent form. Each patient will receive a PIN and all research protocols will be identified only with this PIN. The master list connecting PINs and names will be kept by the rehabilitation facility employee, Dennise Fernandez.
- The study does not have greater than minimal risk.
- Conditions
- Peer Review, Research
- Being tested
- Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationBehavioural
Rehabilitation after hospitalization
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehabilitation time
Actual time spend in rehabilitation
Measured: 30 days
Cooperation with rehabilitation
Willingness to undergo rehabilitation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
Apr 2015Mar 2016
- First posted8 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionMar 2016
Why it stopped: Administrative problems with study director
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer Review, ResearchStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411734
- Sponsor's protocol ID
- Pro 00018268
- Acronym
- Executive
- Status last verified
- May 2016
- First submitted
- 11 Dec 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Executive Dysfunction on Rehabilitation Potential
- ClinicalTrials.gov ID
- NCT02411734
- Acronym / sponsor ID
- Executive / Pro 00018268
- Conditions
- Peer Review, Research
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administrative problems with study director
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Apr 2015 (estimated)
- 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.
Executive function will be tested in patients admitted for rehabilitation and correlated with rehabilitation success
Detailed description
- Rationale: Many patients who were hospitalized benefit from rehabilitation after they are discharged. Rehabilitation may be provided in one of several settings, including home, nursing home or facility specializing in rehabilitation. Success of rehabilitation depends on patient's ability and willingness to cooperate with rehabilitation staff. Unfortunately, some patients cannot or do not follow the rehabilitation protocol. If they do not participate in rehabilitation for at least 90 minutes/day, they have to be discharged from a rehabilitation facility. It would be useful to be able to predict which patients will have problem with rehabilitation after they are admitted from an acute care setting. In this study, the investigators will test the hypothesis that executive function is important for achieving rehabilitation goals.
- Background: Executive function is a set of mental processes that helps connect past experience with present action. People use it to perform activities such as planning, organizing, strategizing, paying attention to and remembering details, and managing time and space. Executive function was the most important factor for level of care elderly individuals required (Royall, Chiodo, \& Polk, 2005). This study also found that many elderly individuals have impaired executive function even though they have normal cognitive function. Executive function is also related to functional abilities in individuals with mild dementia (Martyr \& Clare, 2012).
- The research question: The hypothesis tested in this study is that rehabilitation potential is decreased in persons with impaired executive function. The purpose of this study is to attempt development of a screening tool that could be used before the patients are admitted for rehabilitation. Results of this screening would alert the rehabilitation facility about possible problems occurring after the patient is admitted for rehabilitation. If such a testing will show that patient's executive function is impaired, rehabilitation results may be improved by treatment of this impairment (Royall et al., 2009).
- Study design: During admission of a patient, Dennise Fernandez will ask patients to state why they need rehabilitation. If they are able to state the reason, Dennise Fernandez will explained the study to them and if the patient is interested she will give him/her the Informed Consent Form. If the patient will be unable to state the reason for rehabilitation, the study will be explained to his/her proxy and informed consent given to the proxy. The patient/proxy will have time to read the Informed Consent on his/her own and ask any questions he/she may have. It the patient/proxy signs the Informed Consent, Dennise Fernandez will ask how old the patient is and the patient will be asked to complete the Trail Making Tests. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Errors affect the patient's score only in that the correction of errors is included in the completion time for the task. It is unnecessary to continue the test if the patient has not completed both parts after five minutes have elapsed. Step 1: Give the patient a copy of the Trail Making Test Part A worksheet and a pen or pencil. Step 2: Demonstrate the test to the patient using the sample sheet (Trail Making Part A - SAMPLE). Step 3: Time the patient as he or she follows the "trail" made by the numbers on the test. Step 4: Record the time. Step 5: Repeat the procedure for Trail Making Test Part B. Scoring: Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The patient will participate in therapy during their stay, with their participation evaluated by a) amount of time participating in therapy each day, b) need for encouragement by staff to participate. Encouragement will be rated on four point scale: i) no encouragement, ii) minimal encouragement, iii) moderate encouragement, iv) maximum encouragement. 72 hours prior to discharge, they will be asked by Dennise Fernandez to complete again Trail Making Tests.
- Sample size: 100 patients
- Study population: All admitted patients who will meet inclusion criteria will be approached until 100 of them signs the Informed Consent Form. Inclusion criteria:
- Admitted for rehabilitation
- 65 years old or older
- Speaks English Exclusion criteria:
- Unable to read (even with glasses)
- Unable to write
- The expected results of the research: Results of this study will be published in a scientific journal. If the results are positive, a scale will be developed that will inform rehabilitation facility about rehabilitation potential of a patient before he/she is admitted for rehabilitation.
- Principal Investigator: Ladislav Volicer, MD, PhD
- Potential risk to the subjects: The research will not influence rehabilitation of the patients. The only risk is that they may become frustrated if they difficulty accomplishing the Trail Making Tests.
- Experimental Procedures: Administration of the Trail Making Tests and recording duration of rehabilitation and possible need for encouragement. Results of Trail Making Test with be correlated with level of participation in therapy.
- Potential benefit to subjects: None
- Human subjects considerations: Informed consent will be given to patients only after they express interest in research and they will have one day to decide if they want to sign it. If a patient cannot explain the reason for his/rehabilitation, the study will be explained to his/her proxy and the proxy will receive the informed consent form. Each patient will receive a PIN and all research protocols will be identified only with this PIN. The master list connecting PINs and names will be kept by the rehabilitation facility employee, Dennise Fernandez.
- The study does not have greater than minimal risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for rehabilitation after a hospitalization
Key inclusion criteria (1 listed)
- Speaking English
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| RehabilitationRehabilitation after hospitalization | Behavioural | – |
Primary outcome
Rehabilitation time
Time frame: 30 days
Actual time spend in rehabilitation
Cooperation with rehabilitation
Time frame: 30 days
Willingness to undergo rehabilitation
Results and safety
The study was stopped early (reason given: Administrative problems with study director). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peer Review, Research, run by University of South Florida.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Administrative problems with study director). Results are not available in the source record.
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?
Rehabilitation time (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2016.