Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03972579
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2019-05-22
Brief Title:
Behavioral Profile Matching A Precision Medicine Approach to Concussion Rehabilitation
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Behavioral Profile Matching A Precision Medicine Approach to Concussion Rehabilitation
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At least 1 in 5 people who sustain a concussion will have persistent symptoms and difficulties with daily activities The researchers have identified two unhelpful coping styles following a concussion - avoidance and endurance Individuals who engage in avoidance behavior may benefit from a different type of treatment than those who engage in endurance behavior The researchers will evaluate whether assigning individuals to a specific psychologically-informed treatment tailored to their coping style is practical acceptable and beneficial for their recovery
Detailed Description:
Psychosocial factors are known to affect recovery from concussion but are not sufficiently taken into account by current treatment approaches Distinct behavioral profiles after concussion have emerged in our research 1 avoidance where individuals perceive activity as overly dangerous and take care to avoid overexertion and 2 endurance where individuals persist with high levels of activity despite worse symptoms until they crash requiring recuperative rest The researchers hypothesize that patients with these behavioral profiles likely benefit from different treatment approaches The next step in our research program is to evaluate the feasibility and potential impact of tailoring therapies based on an Avoidance-Endurance Model adapted from the chronic pain literature
The proposed project aims to evaluate whether matching patients with concussion to tailored therapies based on their behavioral profile avoidance vs endurance is feasible A secondary aim is to test our hypothesis that participants receiving the intervention matched to their behavioral profile will have less post-treatment disability than mismatched participants
In a pilot double-blind patient assessor RCT with 11 allocation stratified by behavioral profile avoidance vs endurance 64 adults with persistent symptoms after concussion will complete an initial evaluation an activity diary over the following week and then be randomized to receive an interdisciplinary treatment package tailored to avoidance or endurance profiles
In brief the program designed for avoidance will involve graded exposure to cognitively demanding activity eg mental math exercises physical exertion eg treadmill jogging and sensory stimulation eg scenes with visual motion The focus of the endurance program will be pacing ie shifting from symptom-contingent to time-contingent behavior A blinded assessor will administer outcome measures 12 weeks after enrollment Feasibility criteria include acceptability of randomization and treatment tolerability fidelity and adherence
Proposed changes to profile matching study due to COVID-19 pandemic March 30 2020
Due to the COVID-19 pandemic there will be no new enrollments as of March 30 2020 The study will continue to be advertised at concussion clinic group education sessions which are now being held virtually but inform prospective participants that enrollment will be postponed by at least one month Interested patients will be added to a waitlist for screening when the study resumes enrollment once COVID-19 social distancing restrictions are lifted and non-essential businessservices are resumed
For participants who have expressed interest in the study andor have already been screened but have not completed their baseline assessment Defer baseline assessment Inform the participant that the study will resume enrolling when COVID-19 restrictions have been lifted They will keep their place on a study waitlist Patients who have been screened will need to be re-screened when enrollment resumes
For participants who have completed their baseline assessment or are already active in treatment Continue treatment per protocol However participants who have completed no more than 25 of treatment 4 of 16 sessions should be offered the option of a temporary stoppage for at least one month ie the target of completing all 16 sessions within 10 weeks can be dropped If the therapists believe that treatment progress is being significantly impeded by COVID-19 restrictions they may suggest a stoppage The final decision about stoppage should be made by the participant If they prefer a stoppage the therapists should contact the participant in one month to decide whether to resume treatment or delay by another month Any stoppages should be communicated to the study coordinator
For participants who completed treatment or at least 75 of their treatment 12 of 16 sessions by March 13 2020 but did not complete their outcome assessment until after that date Complete the outcome assessment per protocol but add one question immediately following the WHODAS Introduce the question as follows
These questions were about how much difficulty you had with various activities due to your health conditions over the past month In other words I asked you focus on difficulties caused by your concussion andor other health conditions However the investigators recognize that it might be hard to ignore circumstances other than your health conditions when answering these questions Ask To what extent were your answers to these questions affected by the COVID-19 pandemic If they ask what affected by the COVID-19 pandemic means the research assistant may provide examples Such as all of sudden being laid off or asked to work overtime or not being able to go out because of social distancing policies Provide responses 0minimally or not at all 1somewhat 2quite a bit 3very much or entirely
Confirm their response by asking So were it not for the COVID-19 pandemic would you have answered these questions ___________ differently Please also record free text notes if participants provide explanations or reasons Note that this additional question is being asked only for the primary study outcome WHODAS This question will be removed from the protocol one month after COVID-19 social distancing restrictions are lifted and non-essential businessservices are resumed
Changes to the statistical analysis plan
Participants whose treatment progress andor outcome assessment was likely substantially impacted by COVID-19 will be excluded from the primary analysis Participants who treatment progress andor outcome assessment was possibly mildly impacted but not likely substantially impacted by COVID-19 will be included in the primary analysis This will be operationalized according to the Table 1 below
Participants who are eligible completed no more than 4 therapy sessions by March 30 2020 and choose to temporarily stop treatment during the COVID-19 disruption period will not be counted in the numerator or denominator for calculating the retention rate as a feasibility outcome
Coding the COVID_status variable 0
Operational definition
0a Participants who completed their outcome assessment by March 13 2020 0b Participants who completed at least 75 of their treatment 12 of 16 sessions by March 13 2020 and the outcome assessment between March 14 and on April 30 and answered 0 or 1 to the WHODAS COVID question
0c Participants who completed no more than 25 of their treatment 0-4 therapy sessions by March 30 2020 and agreed to temporarily stop treatment before their 5th therapy session until after April 30 2020
0d Participants who enrolled after April 30 2020 0e Participants who meet criteria 1b or 1c below but both of their therapists agreed with the statement therapy goals and progress were not affected by COVID-19 and the participant answered 0 or 1 to the WHODAS COVID question
-Represents participants whose therapy progress and outcome assessment were minimally or not affected by COVID-19 disruptions It captures participants who did most or all of their therapy outside of the COVID-19 disruption period as well as the few who continued therapy unimpeded by COVID-19 disruptions These participants will be included the primary analysis
Coding the COVID_status variable 1
Operational definition
1a Participants who completed at least 75 of their treatment 12 of 16 sessions by March 13 2020 and their outcome assessment between March 14-April 30 2020 and answered 2 or 3 to the WHODAS COVID-19 question
1b Participants who completed more than 25 but less than 75 of their treatment ie 5-11 sessions by March 30 2020 and do not meet criterion 0e
1c Participants who completed no more than 25 of their treatment 0-4 by March 30 2020 and chose to continue treatment during the period in which COVID-19 social distancing restrictions and do not meet criterion 0e
-Represents participants whose therapy progress andor outcome assessment were likely affected by COVID-19 disruptions These participants will be excluded from primary analysis
Note March 14 2020 is the start of the COVID-19 disruption period in British Columbia when the first social distancing policies were introduced April 30 2020 is a placeholder date for when COVID-19 social distancing restrictions are lifted and non-essential businessservices are resumed The actual date will be updated
The proposed project aims to evaluate whether matching patients with concussion to tailored therapies based on their behavioral profile avoidance vs endurance is feasible A secondary aim is to test our hypothesis that participants receiving the intervention matched to their behavioral profile will have less post-treatment disability than mismatched participants
In a pilot double-blind patient assessor RCT with 11 allocation stratified by behavioral profile avoidance vs endurance 64 adults with persistent symptoms after concussion will complete an initial evaluation an activity diary over the following week and then be randomized to receive an interdisciplinary treatment package tailored to avoidance or endurance profiles
In brief the program designed for avoidance will involve graded exposure to cognitively demanding activity eg mental math exercises physical exertion eg treadmill jogging and sensory stimulation eg scenes with visual motion The focus of the endurance program will be pacing ie shifting from symptom-contingent to time-contingent behavior A blinded assessor will administer outcome measures 12 weeks after enrollment Feasibility criteria include acceptability of randomization and treatment tolerability fidelity and adherence
Proposed changes to profile matching study due to COVID-19 pandemic March 30 2020
Due to the COVID-19 pandemic there will be no new enrollments as of March 30 2020 The study will continue to be advertised at concussion clinic group education sessions which are now being held virtually but inform prospective participants that enrollment will be postponed by at least one month Interested patients will be added to a waitlist for screening when the study resumes enrollment once COVID-19 social distancing restrictions are lifted and non-essential businessservices are resumed
For participants who have expressed interest in the study andor have already been screened but have not completed their baseline assessment Defer baseline assessment Inform the participant that the study will resume enrolling when COVID-19 restrictions have been lifted They will keep their place on a study waitlist Patients who have been screened will need to be re-screened when enrollment resumes
For participants who have completed their baseline assessment or are already active in treatment Continue treatment per protocol However participants who have completed no more than 25 of treatment 4 of 16 sessions should be offered the option of a temporary stoppage for at least one month ie the target of completing all 16 sessions within 10 weeks can be dropped If the therapists believe that treatment progress is being significantly impeded by COVID-19 restrictions they may suggest a stoppage The final decision about stoppage should be made by the participant If they prefer a stoppage the therapists should contact the participant in one month to decide whether to resume treatment or delay by another month Any stoppages should be communicated to the study coordinator
For participants who completed treatment or at least 75 of their treatment 12 of 16 sessions by March 13 2020 but did not complete their outcome assessment until after that date Complete the outcome assessment per protocol but add one question immediately following the WHODAS Introduce the question as follows
These questions were about how much difficulty you had with various activities due to your health conditions over the past month In other words I asked you focus on difficulties caused by your concussion andor other health conditions However the investigators recognize that it might be hard to ignore circumstances other than your health conditions when answering these questions Ask To what extent were your answers to these questions affected by the COVID-19 pandemic If they ask what affected by the COVID-19 pandemic means the research assistant may provide examples Such as all of sudden being laid off or asked to work overtime or not being able to go out because of social distancing policies Provide responses 0minimally or not at all 1somewhat 2quite a bit 3very much or entirely
Confirm their response by asking So were it not for the COVID-19 pandemic would you have answered these questions ___________ differently Please also record free text notes if participants provide explanations or reasons Note that this additional question is being asked only for the primary study outcome WHODAS This question will be removed from the protocol one month after COVID-19 social distancing restrictions are lifted and non-essential businessservices are resumed
Changes to the statistical analysis plan
Participants whose treatment progress andor outcome assessment was likely substantially impacted by COVID-19 will be excluded from the primary analysis Participants who treatment progress andor outcome assessment was possibly mildly impacted but not likely substantially impacted by COVID-19 will be included in the primary analysis This will be operationalized according to the Table 1 below
Participants who are eligible completed no more than 4 therapy sessions by March 30 2020 and choose to temporarily stop treatment during the COVID-19 disruption period will not be counted in the numerator or denominator for calculating the retention rate as a feasibility outcome
Coding the COVID_status variable 0
Operational definition
0a Participants who completed their outcome assessment by March 13 2020 0b Participants who completed at least 75 of their treatment 12 of 16 sessions by March 13 2020 and the outcome assessment between March 14 and on April 30 and answered 0 or 1 to the WHODAS COVID question
0c Participants who completed no more than 25 of their treatment 0-4 therapy sessions by March 30 2020 and agreed to temporarily stop treatment before their 5th therapy session until after April 30 2020
0d Participants who enrolled after April 30 2020 0e Participants who meet criteria 1b or 1c below but both of their therapists agreed with the statement therapy goals and progress were not affected by COVID-19 and the participant answered 0 or 1 to the WHODAS COVID question
-Represents participants whose therapy progress and outcome assessment were minimally or not affected by COVID-19 disruptions It captures participants who did most or all of their therapy outside of the COVID-19 disruption period as well as the few who continued therapy unimpeded by COVID-19 disruptions These participants will be included the primary analysis
Coding the COVID_status variable 1
Operational definition
1a Participants who completed at least 75 of their treatment 12 of 16 sessions by March 13 2020 and their outcome assessment between March 14-April 30 2020 and answered 2 or 3 to the WHODAS COVID-19 question
1b Participants who completed more than 25 but less than 75 of their treatment ie 5-11 sessions by March 30 2020 and do not meet criterion 0e
1c Participants who completed no more than 25 of their treatment 0-4 by March 30 2020 and chose to continue treatment during the period in which COVID-19 social distancing restrictions and do not meet criterion 0e
-Represents participants whose therapy progress andor outcome assessment were likely affected by COVID-19 disruptions These participants will be excluded from primary analysis
Note March 14 2020 is the start of the COVID-19 disruption period in British Columbia when the first social distancing policies were introduced April 30 2020 is a placeholder date for when COVID-19 social distancing restrictions are lifted and non-essential businessservices are resumed The actual date will be updated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None