Trial Outcomes & Findings for Metacognitive-Strategy Training in Sub-Acute Stroke (NCT NCT04099511)
NCT ID: NCT04099511
Last Updated: 2026-01-07
Results Overview
The COPM is a semi-structured interview guide for establishing a subject's activity performance levels within self-care, leisure, and productivity. The subject will set a minimum of 5 activity goals, providing a self-rating of 1-10 for level of performance. A higher score indicates a better outcome. An average self-rating score across all 5 activity goals for performance will be used in analysis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Change in baseline to follow-up average performance score (12 weeks after post-intervention assessment)
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
Usual Care Occupational Therapy-Outpatient
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
33
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
Usual Care Occupational Therapy-Outpatient
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
Baseline Characteristics
Metacognitive-Strategy Training in Sub-Acute Stroke
Baseline characteristics by cohort
| Measure |
Usual Care Occupational Therapy-Outpatient
n=29 Participants
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=27 Participants
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 9.8 • n=37 Participants
|
62.3 years
STANDARD_DEVIATION 9.0 • n=56 Participants
|
63.8 years
STANDARD_DEVIATION 9.5 • n=95 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=37 Participants
|
14 Participants
n=56 Participants
|
34 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=37 Participants
|
13 Participants
n=56 Participants
|
22 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
2 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=37 Participants
|
25 Participants
n=56 Participants
|
53 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=37 Participants
|
27 participants
n=56 Participants
|
56 participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Change in baseline to follow-up average performance score (12 weeks after post-intervention assessment)Population: All participants who completed both baseline and follow-up assessments. All participants were included in the baseline analysis
The COPM is a semi-structured interview guide for establishing a subject's activity performance levels within self-care, leisure, and productivity. The subject will set a minimum of 5 activity goals, providing a self-rating of 1-10 for level of performance. A higher score indicates a better outcome. An average self-rating score across all 5 activity goals for performance will be used in analysis
Outcome measures
| Measure |
Usual Care Occupational Therapy-Outpatient
n=22 Participants
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=18 Participants
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
Canadian Occupational Performance Measure (COPM)
|
3.77 score on a scale
Standard Deviation 1.79
|
3.87 score on a scale
Standard Deviation 2.52
|
PRIMARY outcome
Timeframe: Change in baseline to follow-up (12 weeks after post-intervention assessment)Population: Only those who completed both time points included
The PQRS is an observational, objective method of scoring subject activity performance of goals set via the COPM. A blind, trained rater external to the research study team will view video recordings of each subject performing goals. Each goal is rated on a scale of 1 (no activity criteria were met) to 10 (all activity criteria were met). The final score used in the analysis will be an average of all 5 goals.
Outcome measures
| Measure |
Usual Care Occupational Therapy-Outpatient
n=20 Participants
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=19 Participants
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
Performance Quality Rating Scale (PQRS)
|
.069 score on a scale
Standard Deviation .086
|
.92 score on a scale
Standard Deviation .93
|
PRIMARY outcome
Timeframe: Change in baseline to follow-up (12 weeks after post-intervention assessment)Population: only those who completed both time points included
The Life Space Questionnaire is a self-reported measure of community mobility and social participation. It is comprised of 9 yes/no questions related to places visited in the previous three days. Total number of "yes" responses (range 0-9) will be used in the analysis. A higher score indicates better performance.
Outcome measures
| Measure |
Usual Care Occupational Therapy-Outpatient
n=22 Participants
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=19 Participants
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
The Life Space Questionnaire
|
-.50 score on a scale
Standard Deviation 1.37
|
-.05 score on a scale
Standard Deviation .91
|
PRIMARY outcome
Timeframe: Change in baseline to follow-up (12 weeks after post-intervention assessment)Population: only participants who completed both time points included
The Fugl-Meyer is a well-established measure of upper extremity motor performance in individuals with post-stroke hemiparesis. Each item is scored either a 0 (cannot perform), 1 (performs partially), or 2 (performs fully) with a maximum score of 66. Total range for each item is 0-66. A higher score indicates better performance. In the present study, the upper extremity item will be used in analysis. Only the change score is reported/analyzed. A higher change score represents more improvement on the measure.
Outcome measures
| Measure |
Usual Care Occupational Therapy-Outpatient
n=22 Participants
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=19 Participants
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
Fugl-Meyer-Upper Extremity
|
1.09 score on a scale
Standard Deviation 5.97
|
3.68 score on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Change in baseline to follow-up (12 weeks after post-intervention assessment)Population: only participants who completed both time points included
The PHQ-9 is a self-report measure of depressive symptoms. The subject identifies how often over the previous 2 weeks they have experienced 9 depressive symptoms. The total score reflects the severity of depressive symptoms. A score of 21 or greater indicates severe depressive symptoms and the total range for the measure is 0-27. A higher score indicating more depressive symptoms. The change in total score will be used in analysis. A negative change score means and improvement in depressive symptoms
Outcome measures
| Measure |
Usual Care Occupational Therapy-Outpatient
n=20 Participants
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=18 Participants
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
|
-2 score on a scale
Standard Deviation 6.94
|
-2.5 score on a scale
Standard Deviation 4.41
|
SECONDARY outcome
Timeframe: Change in baseline to follow-up (12 weeks after post-intervention assessment)Population: only participants who completed both time points included
The NIH-TB will be used to evaluate subjects' crystallized intelligence. In contrast to the primary outcome of fluid intelligence, crystalized intelligence is more dependent upon previous learning experience. A crystalized intelligence composite T-score will be used in analysis. A T score of 50 indicates the population mean with a standard deviation of 10. A higher T score indicates better performance (less impairment). Only the change in T score reported. A higher positive T score indicates more improvement in crystallized intelligence.
Outcome measures
| Measure |
Usual Care Occupational Therapy-Outpatient
n=19 Participants
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=14 Participants
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
NIH Toolbox (NIH-TB)-Cognition Battery
|
3.63 score on a scale
Standard Deviation 5.04
|
3.93 score on a scale
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: Change in baseline to follow-up (12 weeks after post-intervention assessment) on the participation overall recovery scoreThe SIS is a self-report measure of stroke recovery. Specifically, the measure assesses physical, cognitive, psychosocial, community mobility, and general activity performance on a 5 point Likert scale. There is an additional item for overall recovery rated on a scale of 0 (no recovery) to 100 (full recovery). Only the overall recovery score was used in analysis. The change in overall recovery was analyzed and reported. A higher positive change in overall recovery score indicates greater improved change in perceived recovery.
Outcome measures
| Measure |
Usual Care Occupational Therapy-Outpatient
n=22 Participants
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=19 Participants
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
Stroke Impact Scale (SIS)
|
4.18 score on a scale
Standard Deviation 10.55
|
1.68 score on a scale
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: Change in baseline to follow-up (12 weeks after post-intervention assessment)Population: only participants who completed both time points included
The PROMIS Satisfaction with Social Roles and Activities item bank assesses satisfaction with performing one's usual social roles and activities. The T-score for this assessment will be used in the analysis. A T score of 50 indicates the population mean with a standard deviation of 10. A higher T score indicates higher satisfaction. Only the change in T score reported. A higher positive T score indicates more improvement in satisfaction with social roles and activities.
Outcome measures
| Measure |
Usual Care Occupational Therapy-Outpatient
n=22 Participants
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=19 Participants
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS): Satisfaction With Social Roles and Activities (Item Bank v2.0).
|
0.96 score on a scale
Standard Deviation 0.85
|
0.56 score on a scale
Standard Deviation 0.88
|
Adverse Events
Usual Care Occupational Therapy-Outpatient
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cognitive Orientation to Daily Occupational Performance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Usual Care Occupational Therapy-Outpatient
n=29 participants at risk
Usual Care Occupational Therapy-Outpatient: The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
Cognitive Orientation to Daily Occupational Performance
n=27 participants at risk
Cognitive Orientation to daily Occupational Performance: The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Burn
|
3.4%
1/29 • Number of events 1 • Baseline assessment through post-intervention assessment (time could vary based on treatment dose but between approximately 6-20 weeks)
All AEs reported to by the University of Missouri Health Sciences IRB and the study medical monitor Dr. Joseph Burris. IRB will review also review all AEs as they are reported and also annually when the protocol is renewed. All severe adverse events below will also be reported to the sponsoring IC Program Officer within the timeframe listed.
|
0.00%
0/27 • Baseline assessment through post-intervention assessment (time could vary based on treatment dose but between approximately 6-20 weeks)
All AEs reported to by the University of Missouri Health Sciences IRB and the study medical monitor Dr. Joseph Burris. IRB will review also review all AEs as they are reported and also annually when the protocol is renewed. All severe adverse events below will also be reported to the sponsoring IC Program Officer within the timeframe listed.
|
|
Blood and lymphatic system disorders
Medical complication
|
3.4%
1/29 • Number of events 2 • Baseline assessment through post-intervention assessment (time could vary based on treatment dose but between approximately 6-20 weeks)
All AEs reported to by the University of Missouri Health Sciences IRB and the study medical monitor Dr. Joseph Burris. IRB will review also review all AEs as they are reported and also annually when the protocol is renewed. All severe adverse events below will also be reported to the sponsoring IC Program Officer within the timeframe listed.
|
0.00%
0/27 • Baseline assessment through post-intervention assessment (time could vary based on treatment dose but between approximately 6-20 weeks)
All AEs reported to by the University of Missouri Health Sciences IRB and the study medical monitor Dr. Joseph Burris. IRB will review also review all AEs as they are reported and also annually when the protocol is renewed. All severe adverse events below will also be reported to the sponsoring IC Program Officer within the timeframe listed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place