Post-COVID-19 Syndrome
Conditions
Keywords
covid-19, metacognition, cognition, telehealth, activities of daily living
Brief summary
The first aim of this study is to determine the feasibility of delivering CO-OP remotely to individuals experiencing cognitive impairments that limit everyday activities in post-COVID-19 syndrome (PCS). The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of individuals with PCS. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to an inactive control group, on activity performance, subjective and objective cognition, and quality of life in a sample of individuals who self-report PCS and cognitive impairment.
Detailed description
Post-COVID-19 symptoms (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 similar of cognitive symptoms seen in other conditions. 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. 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. These effects have been demonstrated in 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.
Interventions
BEHAVIORALCO-OP Procedures
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, we introduce the approach to the subject 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 subject identifies a GOAL, and then is guided by the therapist to discover a PLAN to potentially achieve the goal. The subject is then asked to DO the plan (if feasible during the therapy session otherwise asked to complete at home prior to the next treatment session), and subsequently to CHECK to see if the plan worked, i.e. the goal was achieved. This process is repeated until satisfactory performance is met for each established goal.
BEHAVIORALInactive 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. Each contact will be recorded for fidelity monitoring to ensure all active ingredients of the CO-OP intervention are avoided.
Sponsors
University of Missouri-Columbia
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All outcomes assessors will be blinded to participant study group assignment.
Intervention model description
After baseline assessment, subjects will be randomized to one of two groups: (1) a 10-session Cognitive Orientation to daily Occupational Performance (CO-OP) intervention; or (2) a 10-session inactive control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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 STOPBANG) * prior cancer treatment * severe depressive symptoms (\>21 on the Patient Health Questionnaire-9)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | After study completion, an average of 12 weeks | Number of participants enrolled divided by number of individuals screened |
| Retention Rate | After study completion, an average of 12 weeks | Number of participants completing all study procedures divided by number of participants enrolled |
| Telehealth Usability Questionnaire (TUQ) | After study completion, an average of 12 weeks | Measure of telehealth usability from participant's perspective. Self-report Likert scale of 1 (disagree) to 7 (agree). Higher values represent a better outcome. |
| Acceptability of Intervention Measure (AIM) | After study completion, an average of 12 weeks | Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) |
| Intervention Appropriateness Measure (IAM) | After study completion, an average of 12 weeks | Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) |
| Feasibility of Intervention Measure (FIM) | After study completion, an average of 12 weeks | Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) |
| Canadian Occupational Performance Measure (COPM) Performance, Trained Goals | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. |
| Canadian Occupational Performance Measure (COPM) Satisfaction, Trained Goals | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Time | Pre-intervention (week 0) and post-intervention (week 12) | Objective measure of inhibition and cognitive flexibility. Data are presented for condition 4 of color/word switching. Age-adjusted scale scores are presented with a mean of 10 and a standard deviation of 3. Maximum=19, minimum=1. Higher scores indicate better performance. |
| Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Errors | Pre-intervention (week 0) and post-intervention (week 12) | Objective measure of inhibition and cognitive flexibility. Data are presented for condition 4 of color/word switching. Age-adjusted scale scores are presented with a mean of 10 and a standard deviation of 3. Maximum=19, minimum=1. Higher scores indicate better performance. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of cognition. Maximum=5, minimum=1. T-scores are reported with a mean of 50 and a standard deviation of 10. Higher scores indicate fewer perceived cognitive deficits. |
| Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing Subtest | Pre-intervention (week 0) and post-intervention (week 12) | Objective measure of sustained attention. A Z-score of 0 represents the population mean. Higher scores indicate better performance. |
| CANTAB Spatial Working Memory Subtest | Pre-intervention (week 0) and post-intervention (week 12) | Objective measure of working memory and strategy. A Z-score of 0 represents the population mean. Higher scores indicate better performance. |
| CANTAB Stockings of Cambridge Subtest | Pre-intervention (week 0) and post-intervention (week 12) | Objective measure of planning and executive function. A Z-score of 0 represents the population mean. Higher scores indicate better performance. |
| CANTAB Delayed Matching to Sample Subtest | Pre-intervention (week 0) and post-intervention (week 12) | Objective measure of short-term visual recognition memory and attention. A Z-score of 0 represents the population mean. Higher scores indicate better performance. |
| CANTAB Paired Associates Learning Subtest | Pre-intervention (week 0) and post-intervention (week 12) | Objective measure of visual episodic memory. A Z-score of 0 represents the population mean. Higher scores indicate better performance. |
| Canadian Occupational Performance Measure (COPM) Performance, Untrained Goals | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. |
| Canadian Occupational Performance Measure (COPM) Satisfaction, Untrained Goals | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction. |
| World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Physical Domain | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of physical health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived physical health. |
| World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Social Domain | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of social health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived social health. |
| World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Environmental Domain | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of environmental health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived environmental health. |
| World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Spiritual Domain | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of spiritual health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived spiritual health. |
| World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Independence Domain | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of independence. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived independence. |
| World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Psychological Domain | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of psychological health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived psychological health. |
| Cognitive Failures Questionnaires Total Score | Pre-intervention (week 0) and post-intervention (week 12) | Self-report measure of frequency of cognitive errors in daily life. Participants rate each item on a scale of 0 (never) to 4 (very often). Maximum total score=100, minimum total score=0. Higher scores indicate increased perceived cognitive errors. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnna E Boone, PhD, OTR/L
University of Missouri Occupational Therapy
Participant flow
Recruitment details
Dates of the recruitment period: February 2024-April 2025 Types of recruitment: email newsletters, social media posts (Facebook, Instagram, Twitter), flyers in the community, websites (Research Match, University of Missouri Research, Innovation, & Impact).
Pre-assignment details
One participant was enrolled and signed written consent but withdrew during baseline assessment. Therefore, this participant was never randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.667 years STANDARD_DEVIATION 11.3 |
| Education | 17.704 years STANDARD_DEVIATION 2.478 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 21 Participants |
| Sex/Gender, Customized Female | 16 Participants |
| Sex/Gender, Customized Male | 7 Participants |
| Sex/Gender, Customized Other | 1 Participants |
| Time Post-COVID Diagnosis | 27.52 months STANDARD_DEVIATION 14.13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 27 |
| other Total, other adverse events | 1 / 21 | 0 / 27 |
| serious Total, serious adverse events | 0 / 21 | 0 / 27 |
Outcome results
None listed