Cognitive Strategy Training in Post-COVID-19 Syndrome: A Feasibility Trial
Phase: NA
Conditions: Post-COVID-19 Syndrome
Sponsor: University of Missouri-Columbia

Coversheet 
Study Title: Cognitive Rehabilitation in Post-COVID-19 Syndrome: A feasibility trial 
Institution: University of Missouri 
NCT Number: NCT06136871 
IRB Number: 2096158 
Consent Approval Date: May 1, 2023 
Protocol and Statistical Analysis Plan approval date: February 11, 2025 
 
 

 
 

1 
 
Written Consent to Participate in a Research Study 
 
Project Title: Cognitive strategy training in Post-COVID-19 Syndrome: A feasibility trial 
Principal Investigator Name: Anna E. Boone, PhD, MSOT, OTR/L 
IRB Assigned Project Number: 2096158 
Funding Information: National Institutes of Health, National Center for Medical Research and 
Rehabilitation 
 
Key Information About the Study 
 
You are being asked to participate in a research study. The purpose of the research study is to 
evaluate how well a telehealth cognitive intervention works to improve activity performance, 
cognition (i.e., thinking abilities), and quality of life in individuals with post-COVID syndrome 
who are experiencing cognitive impairment that affects everyday life activities. You are being 
asked to take part in in 10 virtual sessions. You are also being asked to complete a series of tests 
before and after the intervention.  \ 
 
Possible benefits include performing everyday life activities better and/or experiencing fewer 
cognitive symptoms. Some possible risks may include: (1) a breach (i.e., break) of 
confidentiality where identifiable health information related to the participants is accidentally 
made available to individuals outside of the research team; (2) emotional distress while talking 
about changes in your abilities due to post-COVID syndrome; or (3) physical injury. Participants 
will be encouraged to perform their activity-related goals at home. Some of these goals involve 
physical activity, (e.g., cooking), in which the participant could sustain a physical injury such as 
a cut on the hand. These activities will all be common everyday life activities that the participant 
is already doing at home. 
 
Please read this form carefully and take your time. Let us know if you have any questions before 
participating. The research team can explain words or information that you do not understand. 
Research is voluntary and you can choose not to participate. If you do not want to participate or 
choose to start then stop later, there will be no penalty or loss of benefits to which you are 
otherwise entitled.  
 
Purpose of the Research 
 
You are being asked to participate in this study because you are (1) between the ages of 18-60 
years, (2) are experiencing persistent symptoms associated with COVID-19, (3) are experiencing 
cognitive symptoms that impact your ability to perform everyday activities, (4) have no 
neurological/psychiatric diagnoses, and (5) are able to read, write, and speak English. The 
purpose of the research study is to evaluate how well a telehealth cognitive intervention works to 
improve activity performance, cognition (i.e., thinking abilities), and quality of life in individuals 
with post-COVID syndrome who are experiencing cognitive impairment that affects everyday 
life activities.  
 
 
 
IRB Approval Date: May 01, 2023; Written Consent Form ID #644100; IRB Application ID #390826

2 
 
What will happen during the study? 
 
You are being be asked to complete the following activities: 
 
• Pre-intervention tests for approximately 2.5 hours that will consist of 
questionnaires, interviews, and thinking tests. 
• 10, 45-minute telehealth intervention sessions. These will either consist of the 
cognitive intervention or weekly contact with the study team. You will be 
randomized to one of two study groups: a treatment group or a control group. 
Within the cognitive intervention, we will work together to identify problems and 
possible solutions to the everyday life activity problems you are having over 10, 
45-minute intervention sessions.  The weekly contact with the study team will 
involve discussion about things you may have done in the past week that could 
have impacted your post-COVID syndrome symptoms and will last 
approximately 20 minutes. Each intervention session will be videorecorded.  
• Post-intervention tests: for approximately 2 hours that will consist of 
questionnaires, interviews, and thinking tests. 
Your participation is expected to last a total of 12 weeks.  
 
There will be about 65 subjects participating in this study. 
 
What are the expected benefits of the study? 
 
You may or may not benefit as a result of your participation in the study. Information learned 
from the study may help other people in the future. You may potentially experience 
improvement in your ability to perform everyday life activities better and/or experience fewer 
cognitive symptoms.  
 
What are the possible risks of participating in this study? 
 
There are minimal risks expected when taking part in this study. There are some that we know 
about and some may not know about yet. Some possible risks include (1) a breach (i.e., break) of 
confidentiality where identifiable health information related to the participants is accidentally 
made available to individuals outside of the research team; (2) emotional distress while 
discussing potentially sensitive topics such as changes in one’s abilities due to post-COVID 
syndrome or suicidal thoughts; or (3) physical injury. 
 
To help lower these possible risks, we will keep your information in a password protected file on 
a secure network that has restricted access. All data obtained by the study team will be for 
research purposes only and will be de-identified prior to data entry into our secure electronic 
database. Additionally, only select members of the research team will have access to 
videorecordings; these recordings will also be stored on a password protected, secure electronic 
platform on Mizzou Servers. Any hard copy data will be locked in filing cabinets in the private 
offices of the PI. All electronic data will be maintained on one web-based, secure, centralized 
database. The database will use the REDCap® platform and can only be accessed through two 
IRB Approval Date: May 01, 2023; Written Consent Form ID #644100; IRB Application ID #390826

3 
 
password protected portals.  All data entered into the REDCap® database will be stored on 
University of Missouri secure servers and will have access restricted to only members of the 
research team. In the rare event participants experience emotional distress when answering 
questions during assessments, they will be reminded that they can choose not to answer any 
questions that may make them uncomfortable and that participation is completely voluntary. 
Additionally, researchers have a list of available mental health resources that can be provided.  
 
We will tell you about any new important information we learn that may affect your decision to 
continue to participate in this study. 
 
What other choices do I have if I don’t want to be in this study? 
 
You are not required to be in this study. You can simply choose not to participate. You can look for 
other research projects you may be interested in instead of this study.  
 
Will I receive compensation for taking part in this study? 
 
You will be compensated (i.e., paid) for taking part in this study. For your time and effort, you will 
receive $60 via check payment within one month of your pre-tests and post-tests for a total of $120. 
Compensation is provided for completion of the pre-intervention tests and post-intervention tests; 
therefore, payment will be prorated if a participant withdraws from the study prior to the post-tests. 
 
Are there any costs for participating in this study? 
 
You should not expect any additional costs by participating in this study.  
 
Other costs to you from being in this study may include childcare and/or time off work.  
 
You should discuss any questions about costs with the researchers before agreeing to participate. 
 
Will information about me be kept private? 
 
The research team is committed to respecting your privacy and keeping your personal information 
confidential. We will make every effort to protect your information to the extent allowed by law. 
Your records will be given a code number and will not contain your name or other information that 
could identify you. The code number that connects your name to your information will be kept in a 
separate, secure location.  
 
When the results of this research are shared, we will remove all identifying information so it will not 
be known who provided the information. Your information will be kept as secure as possible to 
prevent your identity from being disclosed.  
 
What we collected from you as part of this research will not be used or shared for future research 
studies. It will only be used for purposes of this study. 
 
IRB Approval Date: May 01, 2023; Written Consent Form ID #644100; IRB Application ID #390826

4 
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects.  
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by National Institutes of Health which is funding this project or for 
information that must be disclosed in order to meet the requirements of the federal Food and 
Drug Administration (FDA).  You should understand that a Certificate of Confidentiality does 
not prevent you from voluntarily releasing information about yourself or your involvement in 
this research. If you want your research information released to an insurer, medical care 
provider, or any other person not connected with the research, you must provide consent to allow 
the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by 
federal, state, or local law of child abuse and neglect or harm to self or others.  
 
Where can I get more information about this clinical trial? 
 
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. 
law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time. 
 
Who do I contact if I have questions or concerns? 
 
If you have questions about this study or experience a research-related injury, you can contact 
the University of Missouri researcher at (573) 882-7023 or booneae@umsystem.edu. 
If you have questions about your rights as a research participant, please contact the University of 
Missouri Institutional Review Board (IRB) at 573-882-3181 or muresearchirb@missouri.edu. 
The IRB is a group of people who review research studies to make sure the rights and welfare of 
participants are protected.  
 
If you want to talk privately about any concerns or issues related to your participation, you may 
contact the Research Participant Advocacy at 888-280-5002 (a free call) or email 
muresearchrpa@missouri.edu.  
 
 
 
IRB Approval Date: May 01, 2023; Written Consent Form ID #644100; IRB Application ID #390826

5 
 
 
 
 
Do I get a copy of this consent? 
 
You will receive a copy of this consent for your records. 
We appreciate your consideration to participate in this study. 
 
Consent Signatures 
 
 
 
 
Subject’s Signature 
Date  
 
 
 
 
 
 
 
IRB Approval Date: May 01, 2023; Written Consent Form ID #644100; IRB Application ID #390826

Page 1 of 9 
SOCIAL/BEHAVIORAL/EDUCATIONAL RESEARCH PROTOCOL  
UNIVERSITY OF MISSOURI 
 
Project Title: Cognitive strategy training in Post-COVID-19 Syndrome: A feasibility trial 
IRB Number: 2096158 
Version Number: 5  
Version Date: February 11, 2025  
Principal Investigator: Anna E. Boone, PhD 
Funding Source: National Institute of Child Health and Human Development  
 
 
 
 
1. The goal of this proposed project is to evaluate the feasibility and preliminary effect of 
metacognitive strategy training delivered via telehealth methods to improve activity 
performance, cognition, and quality of life in individuals experiencing cognitive 
impairments that limit everyday activities in post-COVID-19 syndrome (PCS). 
2. The precise prevalence and etiology of PCS will become better understood with time, but 
the reality of ongoing symptoms requires immediate intervention to diminish the effect of 
COVID-19 on daily lives. One of the most common PCS symptoms is cognitive 
impairment, or “brain fog.” Cognitive impairment in PCS typically manifests in 
executive functioning difficulties that impact complex or novel task performance. PCS 
cognitive symptoms require the rehabilitation community to investigate ways to: (1) 
reduce the functional impact of the symptoms on daily life and (2) support individuals 
with PCS to establish new habits to improve and maintain health. While the cognitive 
impairment associated with PCS has not been well evaluated, it is reminiscent of 
cognitive symptoms seen in other conditions (e.g., mild stroke, cancer-related cognitive 
impairment, mild traumatic brain injury). The most efficient course of action to address 
this unmet need is to explore established interventions used with neurologically impaired 
populations with persons with PCS. Metacognitive strategy training (MCST) approaches 
are an evidence-based practice standard for improving capacity to self-manage chronic 
cognitive symptoms and reduce their functional impact on everyday life activities.  
Cognitive Orientation to daily Occupational Performance (CO-OP), a specific 
MCST protocol, uses a structured approach to goal-setting and problem-solving to 
compensate for executive functioning deficits and improve client autonomy.1,2 CO-OP is 
a recognized practice standard and has demonstrated positive effects for improving 
function in a number of populations including mild stroke, cancer-related cognitive 
impairment, and traumatic brain injury.1,3-6 The goal of CO-OP is to help participants 
develop and enhance control over cognitive functions and remove cognitive, emotional, 
and behavioral obstacles inhibiting performance. The CO-OP approach is an MCST 
intervention in which participants are taught a general cognitive strategy that can be 
applied in known and novel contexts to devise task specific strategies for engaging in an 
activity. Existing evidence with other populations suggests that CO-OP has more of a 
positive effect on improving activity performance and cognition than 
remediation/retraining-based approaches.1 These effects have been demonstrated in 
I. 
Research Objectives/Background 

Page 2 of 9 
individuals with mild cognitive impairment that mirrors that found in PCS.  The overall 
research hypothesis is that CO-OP can feasibly be administered remotely and will 
improve activity performance, subjective and objective cognitive function, and quality of 
life in individuals with PCS. 
 
 
1. All participants will have had a COVID-19 diagnosis and will have experienced ongoing 
symptoms for a minimum of 6 weeks. These ongoing symptoms will include self-
reported cognitive impairment that is impacting ability to participate in daily life 
activities. All patients seen at MU Healthcare for a COVID-19 diagnosis will be available 
for recruitment for this study through the MU School of Medicine Show Me Portal. A 
recruitment flyer will be used to recruit individuals from the community. We will also 
share the recruitment flyer virtually on Facebook support group pages and via email blast 
with the help of the Washington University Research Participant Registry (RPR) and 
MUInfo. We will also advertise the study on researchmatch.org and the MU RII website 
using IRB-approved language and our recruitment flyer. 
 
2. The MU School of Medicine Show Me Portal and MU’s data request system will identify 
potential participants based on the following inclusion/exclusion criteria of this study (see 
complete list below): (1) age, (2) COVID-19 diagnosis.  Contact information for potential 
participants will be forwarded to the research team for this study.  Potential participants 
will be contacted over the phone by a research coordinator to determine interest in this 
study. A maximum of three calls will be made in attempt to reach participants. If a 
participant does not answer, a voicemail will be left. Interested potential participants will 
complete a 10-minute prescreening survey via phone to further establish eligibility. After 
completion of the prescreening survey, the research coordinator will arrange a time to 
obtain electronic written informed consent and to complete the screening/baseline 
assessment remotely via Zoom teleconferencing platform. 
 
 
 
1. Potential participants who are scheduled for a baseline assessment will be e-mailed a 
copy of the consent form prior to the baseline testing session to allow sufficient time for 
review. On the first session via videoconferencing the research coordinator or research 
assistant will explain the informed consent process to the potential participant. The 
specific details on the informed consent form will be reviewed. In particular, the person 
will be told the procedures they will participate in, the potential risks and benefits of 
participation, and their right to refuse participation at any time without any effect on 
subsequent health care. The person then will be given another opportunity to read the 
consent form. After reading it, the study team member will answer any specific questions, 
highlight the important details of the study again, and remind the person of their rights as 
a participant. The person will then be asked to electronically sign the consent form if they 
would like to participate. A copy of the form will be electronically given to the person via 
email for their records.  The electronic consent form will be filed on a secure server and 
will only be accessible by a few members of the research team.  
II. 
Recruitment Process 
III. 
Consent Process 

Page 3 of 9 
 
 
 
Inclusion Criteria:  
• 
18-60 years of age   
• 
self-reported cognitive symptoms persisting for at least 6 weeks following 
COVID-19 infection (Cognitive Failures Questionnaire (CFQ) score >43)   
• 
self-identified activity performance goals per the Canadian Occupational 
Performance Measure (COPM) 
• 
documented prior diagnosis of COVID-19   
• 
read, write, and speak English fluently; and   
• 
ability to provide valid informed electronic consent.   
 
Exclusion Criteria:  
• 
diagnosis of severe neurological or psychiatric condition(s)  
• 
dementia symptoms as indicated by a score of <23 on the Montreal Cognitive 
Assessment (MoCA)  
• 
untreated sleep apnea (≥5 on the STOP-Bang)  
• 
prior cancer treatment  
• 
severe depressive symptoms (>21 on Patient Health Questionnaire-9) 
The screening methods identified in parentheses next to appropriate inclusion/exclusion criteria 
will be used to verify appropriate selection of study participants.  
 
 
 
 
1. We will enroll approximately 65 (final sample of 52 human participants) for this single-
blind, parallel, randomized clinical trial.  
2. The purpose of this R21 is to obtain estimates of effect and precision of response so that a 
more formal sample size calculation can accompany our future NIH R01 application. A 
total sample size of 65 will allow for 52 participants required for this study after 25% 
attrition. While we will not complete hypothesis testing, we used the following 
assumptions of hypothesis testing to estimate our sample: (1) power of 0.80; (2) a 2-tailed 
alpha of .05; and (3) an estimated attrition rate of 25%. The primary outcome of the 
intervention is activity performance, therefore, the Canadian Occupational Performance 
Measure (COPM) was used to drive the power analysis. A sample size of 65 will allow 
for detection of a large between groups effect (Cohen’s d = 0.8 or greater) which is a 
conservative estimate based upon our prior work that has demonstrated large effects on 
the COPM in stroke (d=1.6) and cancer-related cognitive impairment (r=0.88). 
Additionally, this sample size is sufficient to permit detection of the minimally clinically 
important difference (MCID) of the COPM (i.e., 2 points) with standard deviations 
obtained from our team’s prior work. Based on these assumptions, a minimum sample of 
65 participants would need to be enrolled.  
 
 
IV. 
Inclusion/Exclusion Criteria 
V. 
Number of Participants 
VI. 
Study Procedures/Study Design 

Page 4 of 9 
1. This is a single-blind, parallel, exploratory, randomized controlled trial to further evaluate 
the feasibility and the effect of remote delivery of CO-OP on cognitive impairment 
limiting activity performance in PCS. Individuals from the community and MU 
HealthCare will be recruited. Those meeting initial screening criteria will undergo further 
screening and eligible participants will complete baseline assessment remotely. After 
baseline assessment, participants will be randomized to one of two groups: (1) a 10-
session CO-OP intervention; or (2) an inactive control group. Block randomization will 
be used to ensure equal distribution between groups. The study statistician will create and 
oversee the randomization sequence. Each CO-OP session will last 45 minutes and 
participants will complete one session per week over the course of 10 weeks. Participants 
will complete the same assessment battery that was completed at baseline at post-
intervention remotely.  
a. Cognitive Orientation to daily Occupational Performance (CO-OP). CO-OP is a 
metacognitive strategy training intervention that will be used in this study. First, 
five functional, everyday life goals are identified collaboratively by the 
participant and interventionist. In the second meeting, when CO-OP actually 
begins, we introduce the approach to the participant and teach the global cognitive 
strategy (i.e., GOAL-PLAN-DO-CHECK). In all subsequent sessions, this 
strategy is used as the main problem-solving framework to facilitate skill 
acquisition. The participant identifies a GOAL, and then is guided by the therapist 
to discover a PLAN to potentially achieve the goal. The participant is then asked 
to DO the plan (if feasible during the therapy session otherwise asked to complete 
at home prior to the next intervention session), and subsequently to CHECKto see 
if the plan worked, i.e. the goal was achieved. This process is repeated until 
satisfactory performance is met for each established goal. 
b. Inactive Control Group: An inactive control group will be used to control for 
maturation and testing effects. Weekly contact will be made via teleconferencing 
to (1) maintain study engagement, (2) introduce weekly social contact with 
researchers, mimicking some of the potential incidental effects of the 
experimental group, and (3) ascertain what, if any, additional steps participants 
have taken to reduce PCS symptoms. The content of each of these meetings will 
be tracked in intervention notes. These weekly contacts have no established time 
threshold that must be met but are expected to last no longer than 20 minutes. 
Each contact will be recorded for fidelity monitoring to ensure all active 
ingredients of the CO-OP intervention are avoided. 
 
2. The study duration is approximately 12 weeks. This includes about 2.5 hours of pre-
intervention assessments (Table 1), 10, 45- minute intervention sessions, and about 2 
hours of post-intervention assessments.  
3. All study procedures are for research purposes only.  
4.  
Table 1. Study Measures  
Assessment  
Construct  
Score Evaluated  
Administration 
Time  
Specific 
Aim  
Screening Measures 

Page 5 of 9 
STOP-bang 
Sleep apnea 
symptoms 
Total score  
T1 
1,2 
Patient Health 
Questionnaire-9  
Depressive 
symptoms 
Total score 
T1 
1,2 
Montreal Cognitive 
Assessment (MoCA) 
Cognition 
Total score 
T1 
1,2 
Cognitive Failures 
Questionnaire (CFQ) 
Cognitive abilities in 
everyday life 
Total score 
T1,T2 
1,2 
Primary Outcome Measures  
Feasibility measures  
Recruitment rate, 
retention rate  
N/A  
T2  
1  
Acceptability of Intervention 
Measure (AIM) 
Intervention 
acceptability  
Total score  
T2  
1  
Intervention 
Appropriateness Measure 
(IAM) 
Intervention 
appropriateness  
Total score  
T2  
1  
Feasibility of Intervention 
Measure (FIM) 
Intervention 
feasibility  
Total score  
T2  
1  
Telehealth 
Usability  Questionnaire 
(TUQ) 
Usability of telehealth 
platform  
Total score  
T2  
1  
Canadian Occupational 
Performance Measure 
(COPM)  
Subjective activity 
performance  
Average score 
across goals  
Week 2,4,6 and 
8 and   
T1, T2  
2  
Secondary Outcomes*  
PROMIS Cognitive Function Subjective cognition   T-score  
T1, T2  
2  
Delis-Kaplan Executive 
Function System (DKEFS) 
Color-Word Interference  
Goal maintenance, 
inhibition, cognitive 
flexibility  
Total score  
T1, T2  
2  
WHO-QoL 100 
Quality of life   
Domain scores  
T1, T2  
2  
Cambridge 
Neuropsychological Test 
Automated Battery 
(CANTAB) Rapid Visual 
Information Processing 
Subtest 
Sustained attention Total score 
T1, T2 
2 
CANTAB Spatial Working 
Memory Subtest 
Working memory and 
strategy 
Total score 
T1, T2 
2 
CANTAB Stockings of 
Cambridge Subtest 
Planning and 
executive function 
Total score 
T1, T2 
2 
CANTAB Delayed Matching 
to Sample Subtest 
Short-term visual 
recognition memory 
and attention 
Total score 
T1, T2 
2 
CANTAB Paired Associates 
Learning Subtest 
Visual episodic 
memory 
Total score 
T1, T2 
2 
Additional Data Collected  

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Medical record data  
Medical history 
information  
N/A  
T1  
N/A  
Demographic data  
Description of 
population  
Age, race, gender, 
education level  
T1  
1,2  
Therapy logs  
Description of 
intervention 
provided  
N/A  
Continuously 
monitored  
1, 2  
 
21-Item Word List 
Performance Validity Test 
(PVT) 
Exaggeration or 
feigning of memory 
impairment 
Total score 
T1 
1, 2 
 
 
 
 
 
1. There are minimal risks expected when taking part in this study. There are some that we 
know about and some may not know about yet. Some possible risks include (1) a breach 
of confidentiality where identifiable health information related to the participants is 
inadvertently made available to individuals beyond the research team; (2) psychological 
distress while discussing changes in your abilities due to PCS; or (3) physical injury. 
Should a participant indicate mental health concerns by (1) an affirmative answer on the 
Patient Health Questionnaire item "Thoughts that you would be better off dead, or of 
hurting yourself in some way," or a score of >21 on the PHQ-9, a document with mental 
health resources will be provided and the participant will be asked to contact either a 
trusted personal contact or a mental health emergency hotline while still in the Zoom 
meeting with the assessor. 
 
2. To help lower these possible risks, we will keep participant information in a password 
protected file on a secure network that has restricted access. All data will be obtained by 
the study team will be for research purposes only and will be de-identified prior to data 
entry into our secure electronic database. Any hard copy data will be locked in filing 
cabinets in the private offices of the PI. All electronic data will be maintained on one 
web-based, secure, centralized database. The database will use the REDCap® platform 
and can only be accessed through two password protected portals.  All data entered into 
the REDCap® database will be stored on University of Missouri secure servers and will 
have access restricted to only members of the research team. In the rare event participants 
experience psychological distress when answering questions during assessments, they 
will be reminded that they can decline to answer any questions that may make them 
uncomfortable and that participation is completely voluntary.  
3. The table below provides information on how AEs will be reported in this study (see 
Table 1).  The plan for reporting has been determined based on the severity of the AE and 
the study attribution of the AE per the definitions and categories previously discussed.  
VII. 
Potential Risks 

Page 7 of 9 
The reporting timeframe meets or exceeds the reporting requirements of the University of 
Missouri IRB.  All AEs will be reported to by the University of Missouri IRB.  IRB will 
review these 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.  The University of Missouri IRB maintains a log of all 
reported AEs, including all details related to the AE, actions taken, and outcomes, over 
the course of the study that will be used by the study team for tracking purposes.   
 
Table 1:  AE Reporting Plan 
Study Attribution 
Time for Reporting by type of AE 
 
Mild 
Moderate 
Severe 
Unrelated 
Not required 
Not required 
5 days 
Definitely Related 
5 days 
5 days 
24 hours 
Probably Related 
5 days 
5 days 
24 hours 
Possibly Related 
5 days 
5 days 
24 hours 
 
 
 
1. Participants may or may not directly benefit as a result of participation in the study. 
Information learned from the study may likely help other people in the future. 
Participants may potentially experience improvement in their ability to perform everyday 
life activities better and/or experience less cognitive impairment.  
 
 
 
1. Participants will be compensated for taking part in this study. For time and effort, 
participants will receive $60 via check payment within one month of pre-assessments and 
post-assessments for a total of $120. Compensation is provided for completion of the pre-
intervention assessment battery and post-intervention assessment battery; therefore, payment 
will be prorated if a participant withdraws from the study prior to the post-intervention 
assessment battery (e.g., they would only be compensated for the assessment time points 
that were actually completed). 
 
 
 
Data Quality and Management 
 
The research coordinator will oversee the review of all data collection forms on an 
ongoing basis for data completeness and accuracy, as well as protocol compliance. The table 
below is an overview of the schedule for data review (see Table 2). All data files completed 
during the specified time period will be reviewed. The study coordinator will assign a rater to 
review each file who was not the person who collected the data. The reviewer will complete an 
audit sheet to review the completeness and accuracy of each data file.  Data verification will be 
completed on all outcome data by double data entry.  All data will be entered into a separate 
electronic database. The research coordinator will cross-check the two data files and resolve any 
discrepancies. The results of the data verification will be reported on the audit form. All audit 
VIII. Anticipated Benefits 
IX. 
Compensation 
X. 
Data Safety Monitoring Plan 

Page 8 of 9 
forms will be reviewed by the PI and further training of blind raters will occur if consistent errors 
are noted. Any protocol violations will be reported to the University of Missouri IRB. 
 
Intervention fidelity and protocol adherence will be reviewed by Drs. Boone, Kiselica, 
and Wolf. The CO-OP Academy has developed a CO-OP Fidelity Checklist that is used to 
monitor fidelity of the CO-OP intervention. This checklist will be completed by reviewing video 
recordings of intervention sessions and therapists must maintain an overall score of 80% to be 
compliant with the intervention. Any items missed on the checklist will be reviewed with the 
therapist during the next weekly meeting following the audit. Failure to maintain an 80% on any 
fidelity check will require individual instruction. For every participant, a minimum of two 
sessions are recorded: (1) one from sessions 2-5; and (2) one from sessions 6-9. Additional 
sessions may be recorded and reviewed, if therapists are consistently scoring at or below the 80% 
threshold. 
 
Table 2: Schedule for Data Review 
Data type 
Frequency of review 
Reviewer 
Subject accrual (including 
compliance with protocol 
enrollment criteria) 
Quarterly 
Blind rater (confirmation by 
researcher coordinator and 
Dr.Boone, PI)  
Status of all enrolled 
participants, as of date of 
reporting  
Quarterly 
Blind rater (confirmation by 
researcher coordinator and Dr. 
Boone, PI) 
Outcome data accuracy 
(double-data entry) 
Quarterly 
Blind rater (confirmation by 
researcher coordinator and Dr. 
Boone, PI) 
Adherence data regarding study 
visits and intervention 
Quarterly 
PI 
Intervention fidelity 
Quarterly 
Dr. Wolf, Co-I (with CO-OP 
Academy) 
AEs and rates  
Quarterly 
PI 
 
Participant Accrual and Compliance 
     Per Table 2 above, review of the rate of participant accrual and compliance with 
inclusion/exclusion criteria will occur quarterly during the recruitment phase to ensure that: (1) a 
sufficient number of participants are being enrolled; (2) participants are meeting eligibility 
criteria; and (3) the targeted ethnic diversity goals outlined in the grant proposal are being met.  
 
Stopping Rules 
     This study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse effects that call into question the safety of the intervention; (2) difficulty in study 

Page 9 of 9 
recruitment or retention will significantly impact the ability to evaluate the study endpoints; 
(3) any new information becomes available during the trial that necessitates stopping the trial; or 
(4) other situations occur that might warrant stopping the trial. 
 
Safety Review Plan 
     Study progress and safety will be reviewed quarterly per above. Annual progress reports, 
including patient recruitment, retention/attrition, and AEs, will be provided to the University of 
Missouri IRB. The annual report will include a list and summary of AEs. In addition, the annual 
report will address (1) whether AE rates are consistent with pre-study assumptions; (2) reason for 
dropouts from the study; (3) whether all participants met entry criteria; (4) whether continuation 
of the study is justified on the basis that additional data are needed to accomplish the stated aims 
of the study; and (5) conditions whereby the study might be terminated prematurely. The annual 
report will be provided to the sponsoring IC. The IRB and other applicable recipients will review 
progress of this study on an annual basis. 
 
 
 
 
1. N/A 
2.  
 
 
 
 
 
1. 
McEwen S, Polatajko H, Baum C, et al. Combined cognitive-strategy and task-specific training 
improve transfer to untrained activities in subacute stroke: an exploratory randomized controlled trial. 
Neurorehabilitation and neural repair. 2015;29(6):526-536.  
2. 
Geusgens C, Van Heugten C, Cooijmans J, Jolles J, van den Heuvel W. Transfer effects of a 
cognitive strategy training for stroke patients with apraxia. Journal of clinical and experimental 
neuropsychology. 2007;29(8):831-841.  
3. 
Haskins EC, Cicerone KD, Trexler LE. Cognitive rehabilitation manual: Translating evidence-based 
recommendations into practice. ACRM Publishing; 2012. 
4. 
Cicerone KD, Dahlberg C, Malec JF, et al. Evidence-based cognitive rehabilitation: updated 
review of the literature from 1998 through 2002. Archives of physical medicine and rehabilitation. 
2005;86(8):1681-1692.  
5. 
Dawson DR, Anderson ND, Burgess P, Cooper E, Krpan KM, Stuss DT. Further development of the 
Multiple Errands Test: Standardized scoring, reliability, and ecological validity for the Baycrest version. 
Archives of physical medicine and rehabilitation. 2009;90(11):S41-S51.  
6. 
Wolf TJ, Polatajko H, Baum C, et al. Combined cognitive-strategy and task-specific training 
affects cognition and upper-extremity function in subacute stroke: an exploratory randomized 
controlled trial. American Journal of Occupational Therapy. 2016;70(2):7002290010p1-7002290010p10.  
 
XI. 
Multiple Sites 
XII. 
References