Cognitive Strategy Training in Post-COVID-19 Syndrome: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Telehealth Usability Questionnaire (TUQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All outcomes assessors will be blinded to participant study group assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Cognitive Orientation to daily Occupational Performance (CO-OP)
Each CO-OP session will last 45 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
干预措施: CO-OP Procedures (Behavioral)
Inactive Control Group
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
干预措施: Inactive Control Group (Behavioral)
结局指标
主要结局
Telehealth Usability Questionnaire (TUQ)
时间窗: 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)
Acceptability of Intervention Measure (AIM)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: Pre-intervention (week 0), week 2, week 4, week 6, week 8, and post-intervention (week 12)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Retention Rate
时间窗: After study completion, an average of 12 weeks
Number of participants completing all study procedures divided by number of participants enrolled
Recruitment Rate
时间窗: After study completion, an average of 12 weeks
Number of participants enrolled divided by number of individuals screened
Canadian Occupational Performance Measure (COPM) Performance, Trained Goals
时间窗: 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
时间窗: 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.
次要结局
- CANTAB Spatial Working Memory Subtest(Pre-intervention (week 0) and post-intervention (week 12))
- CANTAB Paired Associates Learning Subtest(Pre-intervention (week 0) and post-intervention (week 12))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function(Pre-intervention (week 0) and post-intervention (week 12))
- Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing Subtest(Pre-intervention (week 0) and post-intervention (week 12))
- CANTAB Stockings of Cambridge Subtest(Pre-intervention (week 0) and post-intervention (week 12))
- CANTAB Delayed Matching to Sample Subtest(Pre-intervention (week 0) and post-intervention (week 12))
- Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Time(Pre-intervention (week 0) and post-intervention (week 12))
- Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Errors(Pre-intervention (week 0) and post-intervention (week 12))
- Canadian Occupational Performance Measure (COPM) Performance, Untrained Goals(Pre-intervention (week 0) and post-intervention (week 12))
- Canadian Occupational Performance Measure (COPM) Satisfaction, Untrained Goals(Pre-intervention (week 0) and post-intervention (week 12))
- World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Physical Domain(Pre-intervention (week 0) and post-intervention (week 12))
- World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Social Domain(Pre-intervention (week 0) and post-intervention (week 12))
- World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Environmental Domain(Pre-intervention (week 0) and post-intervention (week 12))
- World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Spiritual Domain(Pre-intervention (week 0) and post-intervention (week 12))
- World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Independence Domain(Pre-intervention (week 0) and post-intervention (week 12))
- World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Psychological Domain(Pre-intervention (week 0) and post-intervention (week 12))
- Cognitive Failures Questionnaires Total Score(Pre-intervention (week 0) and post-intervention (week 12))
研究者
Anna Boone
Assistant Professor, Occupational Therapy
University of Missouri-Columbia