Ignite Creation Date:
2024-05-06 @ 1:30 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04048122
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2019-08-01
Brief Title:
Feasibility and Effect of a Strategy-Based Cognitive Intervention for Parkinson Disease
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Strategy-based Cognitive Intervention for Parkinson Disease A Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Parkinson disease PD affects over 1 million Americans and causes considerable personal and socioeconomic costs 34 billionyear in the US that are expected to rise as the population ages Cognitive impairment produces disability and reduced quality of life among non-demented people with PD Surgical and pharmacologic treatments for PD do not prevent or treat cognitive impairment and may even exacerbate the problem As such cognitive rehabilitation treatments that mitigate its negative functional consequences are a top research priority
Unfortunately existing cognitive rehabilitative programs for PD which focus on restoring deficient cognitive processes through process training repetitive practice of tasks that challenge specific cognitive processes have had limited effect on daily function To overcome this limitation the investigators take a strategy training approach Trained occupational therapists teach people targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish meaningful daily activities Contemporary cognitive rehabilitation evidence supports this approach for people with chronic neurocognitive dysfunction from stroke and brain injury however it has not been studied in PD By teaching strategies for everyday cognition and using training techniques to support transfer of learning beyond the training context the investigators hypothesize that our strategy training interventions will produce better functional outcomes for people with PD compared to process training
The investigators developed MultiContext for PD MC4PD to enable people with PD to apply strategies in their everyday lives to cope with cognitive decline and improve or maintain daily function MC4PD is an individualized community-based intervention that focuses on the attainment of personally meaningful functional goals using training techniques known to enhance strategy learning and transfer In an iterative case series the investigators fine-tuned the treatment protocol established good participant acceptance and engagement and provided preliminary data on its benefits for daily cognitive function The next step is to confirm MC4PDs feasibility in a randomized controlled trial RCT In this project the investigators will assess feasibility and treatment fidelity and generate data in preparation for a definitive RCT by conducting a single-blind pilot RCT comparing MC4PD to a standard-of-care treatment Control Individuals with PD will complete pre-treatment testing randomization to treatment group 10 treatment sessions and immediate and 3 months post-treatment testing
Unfortunately existing cognitive rehabilitative programs for PD which focus on restoring deficient cognitive processes through process training repetitive practice of tasks that challenge specific cognitive processes have had limited effect on daily function To overcome this limitation the investigators take a strategy training approach Trained occupational therapists teach people targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish meaningful daily activities Contemporary cognitive rehabilitation evidence supports this approach for people with chronic neurocognitive dysfunction from stroke and brain injury however it has not been studied in PD By teaching strategies for everyday cognition and using training techniques to support transfer of learning beyond the training context the investigators hypothesize that our strategy training interventions will produce better functional outcomes for people with PD compared to process training
The investigators developed MultiContext for PD MC4PD to enable people with PD to apply strategies in their everyday lives to cope with cognitive decline and improve or maintain daily function MC4PD is an individualized community-based intervention that focuses on the attainment of personally meaningful functional goals using training techniques known to enhance strategy learning and transfer In an iterative case series the investigators fine-tuned the treatment protocol established good participant acceptance and engagement and provided preliminary data on its benefits for daily cognitive function The next step is to confirm MC4PDs feasibility in a randomized controlled trial RCT In this project the investigators will assess feasibility and treatment fidelity and generate data in preparation for a definitive RCT by conducting a single-blind pilot RCT comparing MC4PD to a standard-of-care treatment Control Individuals with PD will complete pre-treatment testing randomization to treatment group 10 treatment sessions and immediate and 3 months post-treatment testing
Detailed Description:
Parkinson disease PD affects over 1 million Americans and causes considerable personal and socioeconomic costs 34 billionyear in the US that are expected to rise as the population ages Cognitive impairment produces disability and reduced quality of life among non-demented people with PD Surgical and pharmacologic treatments for PD do not prevent or treat cognitive impairment and may even exacerbate the problem As such cognitive rehabilitation treatments that mitigate its negative functional consequences are a top research priority
Unfortunately existing cognitive rehabilitative programs for PD which focus on restoring deficient cognitive processes through process training repetitive practice of tasks that challenge specific cognitive processes have had limited effect on daily function To overcome this limitation the investigators take a strategy training approach Trained Occupational Therapists teach people targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish meaningful daily activities Contemporary cognitive rehabilitation evidence supports this approach for people with chronic neurocognitive dysfunction from stroke and brain injury however it has not been studied in PD By teaching strategies for everyday cognition and using training techniques to support transfer of learning beyond the training context the investigators hypothesize that our strategy training interventions will produce better functional outcomes for people with PD compared to process training
The investigators developed MultiContext for PD MC4PD to enable people with PD to apply strategies in their everyday lives to cope with cognitive decline and improve or maintain daily function MC4PDis an individualized community-based intervention that focuses on the attainment of personally meaningful functional goals using training techniques known to enhance strategy learning and transfer In an iterative case series the investigators fine-tuned the treatment protocol established good participant acceptance and engagement and provided preliminary data on its benefits for daily cognitive function The next step is to confirm MC4PDs feasibility in a randomized controlled trial RCT In this project the investigators will assess feasibility and treatment fidelity and generate data in preparation for a definitive RCT by conducting a single-blind pilot RCT comparing MC4PD to a standard-of-care treatment Control Individuals with PD N 60 will complete pre-treatment testing randomization to treatment group 10 treatment sessions and immediate and 3 months post-treatment testing
Aim 1 Examine the feasibility of MC4PD within an RCT H1 Study recruitment will be 4 participantsmonth retention in both treatment groups will be 4 participantsmonth retention in both treatment groups will be or equal to 85 and greater than or equal to 85 of participants in both groups will complete the intervention in 12 weeks The investigators will track recruitment retention intervention duration and reasons for non-enrollment or attrition throughout the study period
Aim 2 H2a Therapists will deliver MC4PD with high adherence and competence Blinded raters will rate therapist adherence and competence for a random sample 30 n180 of MC4PD and Control treatment sessions The investigators will calculate adherence and competence to MC4PD for each therapist adherence or equal to 80 and competence greater than or equal to 3 of 4 possible indicating at least Well done will be benchmarks for good treatment integrity H2b MC4PD participants will have good acceptance receipt and enactment of treatment MC4PD participants will complete the Client Satisfaction Questionnaire CSQ-8 at post-treatment and blinded raters will rate participants session participation Pittsburgh Rehabilitation Participation Scale PRPS and homework completion CSQ-8 scores greater than or equal to 24 of 32 possible indicating all positive responses PRPS scores greater than or equal to 4 of 6 indicating at least Good and homework completion rates greater than or equal to 80 will be benchmarks for good acceptance receipt and enactment respectively
Aim 3 Obtain preliminary estimates of MC4PDs effect on patient-reported functional cognition H3 exploratory MC4PD participants will report greater improvement in functional cognition than Control participants immediately and 3 months after treatment The Investigators will use the Bangor Goal Setting Interview BGSI a reliable and responsive rehabilitation outcome measure to identify 3-5 functional cognitive problems and set related goals for each participant Participants will rate their attainment of each goal at pre post and follow-up 10-point scales higher is better scores are averaged across problems
The investigators hypothesize that MC4PD can enable people with PD to manage everyday cognitive challenges so they can perform and participate in desired activities and roles Such an intervention could improve function and quality of life reduce caregiver burden and enhance clinical care for this population This specific study is part of a rigorous developmental process designed to optimize MC4PD for clinical trials and eventual translation into clinical practice It is significant because it will provide us with feasibility data fidelity enhancements clinical trials infrastructure experience training and monitoring therapists and an estimate of treatment effect-all essential elements for efficiency rigor reproducibility and payoff in future clinical trials as well as for implementation and sustainability in real-world clinical practice
Participants will complete pre-treatment assessment and then will be randomized to treatment arm MC4PD or Control Standard of Care Both arms will consist of 10 individualized treatment sessions within a 12-week period
Both treatments consist of 10 1-hour sessions over 12 weeks delivered in an individual face-to-face format in participants homes andor communities by trained licensed occupational therapists OTs All treatment sessions will be audiotaped to assess the therapists adherence and competence to the cognitive treatments
Arm 1 - MC4PD This treatment focuses on improving functional performance by enhancing the generation and use of strategies-which can be internal eg self-talk planning or external eg checklist alarm-to circumvent cognitive processing limitations caused by PD It uses a standardized approach across and within sessions for all clients while being tailored to each clients cognitive problems and goals The first session begins with a discussion of pre-treatment cognitive test results from the recruitment source study The purpose of this is to 1 begin building the clients awareness of cognitive strengths and limitations and how they may relate to daily function and 2 inform individualized goal setting and treatment planning Then the OT explains MC4PD purpose and process conducts the Bangor Goal Setting Interview to collaboratively identify functional cognitive problems and set related treatment goals and assigns the first homework record and reflect on daily cognitive lapses All subsequent treatment sessions consist of a review of prior sessions and learning homework review treatment activities homework provision and session recap Each sessions treatment activities are selected collaboratively based on the clients goals and preferences and the OTs assessment of the clients cognitive and functional status They involve the performance of simulated functional activities with OT mediation to help the client anticipate performance problems generate and use strategies to support performance evaluate and modify performance and strategy use and transfer these principles to other activities The OTs expertise in functional cognition task and performance analysis and task grading guides this process Treatment activities also involve in-depth discussion of these issues including making explicit connections between the simulated functional activities strategies and the clients real-life experiences to promote generalization of learning Homework consists of action plans for using the strategies generated and practiced during the treatment session in specific everyday life situations Clients record instances of strategy use or missed opportunities along with their evaluation of strategy effectiveness and potential modifications on a structured worksheet which is reviewed collaboratively in the next session In this way homework not only supports real-life strategy application and practice but it also reinforces self-monitoring self-evaluation problem solving strategy self-generation and strategy optimization Treatment progresses through three general phases 1 Understand and define problems and goals 2 Generate execute and evaluate strategies 3 Generalize and reinforce strategy use and increases in difficulty but progression is flexible depending on the clients goals and abilities
Arm 2 - Control This treatment is task-oriented training a widely-used approach in neurorehabilitation that parallels the cognitive process training used in PD to-date but with simulated functional tasks vs computer or paper pencil tasks It has the same basic protocol as MC4PD but it is therapist-directed and the OT does not address strategies metacognition generalization or use mediation or action plans Therefore this is a standard-of-care approach that includes all but the proposed critical elements of MC4PD The OT reviews pre-treatment cognitive test scores with the client but without discussion to build awareness The OT selects treatment activities based on the clients cognitive profile and goals from a published set of activities designed for use in cognitive interventions Graded task practice with OT feedback on performance accuracy is used to produce neurocognitive improvement or possibly independent strategy development The OT assigns practice of specific cognitively challenging everyday life activities for homework but without action plans
Participants will complete assessments related to cognition goal-attainment participation one-week and three-months post-treatment sessions
Unfortunately existing cognitive rehabilitative programs for PD which focus on restoring deficient cognitive processes through process training repetitive practice of tasks that challenge specific cognitive processes have had limited effect on daily function To overcome this limitation the investigators take a strategy training approach Trained Occupational Therapists teach people targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish meaningful daily activities Contemporary cognitive rehabilitation evidence supports this approach for people with chronic neurocognitive dysfunction from stroke and brain injury however it has not been studied in PD By teaching strategies for everyday cognition and using training techniques to support transfer of learning beyond the training context the investigators hypothesize that our strategy training interventions will produce better functional outcomes for people with PD compared to process training
The investigators developed MultiContext for PD MC4PD to enable people with PD to apply strategies in their everyday lives to cope with cognitive decline and improve or maintain daily function MC4PDis an individualized community-based intervention that focuses on the attainment of personally meaningful functional goals using training techniques known to enhance strategy learning and transfer In an iterative case series the investigators fine-tuned the treatment protocol established good participant acceptance and engagement and provided preliminary data on its benefits for daily cognitive function The next step is to confirm MC4PDs feasibility in a randomized controlled trial RCT In this project the investigators will assess feasibility and treatment fidelity and generate data in preparation for a definitive RCT by conducting a single-blind pilot RCT comparing MC4PD to a standard-of-care treatment Control Individuals with PD N 60 will complete pre-treatment testing randomization to treatment group 10 treatment sessions and immediate and 3 months post-treatment testing
Aim 1 Examine the feasibility of MC4PD within an RCT H1 Study recruitment will be 4 participantsmonth retention in both treatment groups will be 4 participantsmonth retention in both treatment groups will be or equal to 85 and greater than or equal to 85 of participants in both groups will complete the intervention in 12 weeks The investigators will track recruitment retention intervention duration and reasons for non-enrollment or attrition throughout the study period
Aim 2 H2a Therapists will deliver MC4PD with high adherence and competence Blinded raters will rate therapist adherence and competence for a random sample 30 n180 of MC4PD and Control treatment sessions The investigators will calculate adherence and competence to MC4PD for each therapist adherence or equal to 80 and competence greater than or equal to 3 of 4 possible indicating at least Well done will be benchmarks for good treatment integrity H2b MC4PD participants will have good acceptance receipt and enactment of treatment MC4PD participants will complete the Client Satisfaction Questionnaire CSQ-8 at post-treatment and blinded raters will rate participants session participation Pittsburgh Rehabilitation Participation Scale PRPS and homework completion CSQ-8 scores greater than or equal to 24 of 32 possible indicating all positive responses PRPS scores greater than or equal to 4 of 6 indicating at least Good and homework completion rates greater than or equal to 80 will be benchmarks for good acceptance receipt and enactment respectively
Aim 3 Obtain preliminary estimates of MC4PDs effect on patient-reported functional cognition H3 exploratory MC4PD participants will report greater improvement in functional cognition than Control participants immediately and 3 months after treatment The Investigators will use the Bangor Goal Setting Interview BGSI a reliable and responsive rehabilitation outcome measure to identify 3-5 functional cognitive problems and set related goals for each participant Participants will rate their attainment of each goal at pre post and follow-up 10-point scales higher is better scores are averaged across problems
The investigators hypothesize that MC4PD can enable people with PD to manage everyday cognitive challenges so they can perform and participate in desired activities and roles Such an intervention could improve function and quality of life reduce caregiver burden and enhance clinical care for this population This specific study is part of a rigorous developmental process designed to optimize MC4PD for clinical trials and eventual translation into clinical practice It is significant because it will provide us with feasibility data fidelity enhancements clinical trials infrastructure experience training and monitoring therapists and an estimate of treatment effect-all essential elements for efficiency rigor reproducibility and payoff in future clinical trials as well as for implementation and sustainability in real-world clinical practice
Participants will complete pre-treatment assessment and then will be randomized to treatment arm MC4PD or Control Standard of Care Both arms will consist of 10 individualized treatment sessions within a 12-week period
Both treatments consist of 10 1-hour sessions over 12 weeks delivered in an individual face-to-face format in participants homes andor communities by trained licensed occupational therapists OTs All treatment sessions will be audiotaped to assess the therapists adherence and competence to the cognitive treatments
Arm 1 - MC4PD This treatment focuses on improving functional performance by enhancing the generation and use of strategies-which can be internal eg self-talk planning or external eg checklist alarm-to circumvent cognitive processing limitations caused by PD It uses a standardized approach across and within sessions for all clients while being tailored to each clients cognitive problems and goals The first session begins with a discussion of pre-treatment cognitive test results from the recruitment source study The purpose of this is to 1 begin building the clients awareness of cognitive strengths and limitations and how they may relate to daily function and 2 inform individualized goal setting and treatment planning Then the OT explains MC4PD purpose and process conducts the Bangor Goal Setting Interview to collaboratively identify functional cognitive problems and set related treatment goals and assigns the first homework record and reflect on daily cognitive lapses All subsequent treatment sessions consist of a review of prior sessions and learning homework review treatment activities homework provision and session recap Each sessions treatment activities are selected collaboratively based on the clients goals and preferences and the OTs assessment of the clients cognitive and functional status They involve the performance of simulated functional activities with OT mediation to help the client anticipate performance problems generate and use strategies to support performance evaluate and modify performance and strategy use and transfer these principles to other activities The OTs expertise in functional cognition task and performance analysis and task grading guides this process Treatment activities also involve in-depth discussion of these issues including making explicit connections between the simulated functional activities strategies and the clients real-life experiences to promote generalization of learning Homework consists of action plans for using the strategies generated and practiced during the treatment session in specific everyday life situations Clients record instances of strategy use or missed opportunities along with their evaluation of strategy effectiveness and potential modifications on a structured worksheet which is reviewed collaboratively in the next session In this way homework not only supports real-life strategy application and practice but it also reinforces self-monitoring self-evaluation problem solving strategy self-generation and strategy optimization Treatment progresses through three general phases 1 Understand and define problems and goals 2 Generate execute and evaluate strategies 3 Generalize and reinforce strategy use and increases in difficulty but progression is flexible depending on the clients goals and abilities
Arm 2 - Control This treatment is task-oriented training a widely-used approach in neurorehabilitation that parallels the cognitive process training used in PD to-date but with simulated functional tasks vs computer or paper pencil tasks It has the same basic protocol as MC4PD but it is therapist-directed and the OT does not address strategies metacognition generalization or use mediation or action plans Therefore this is a standard-of-care approach that includes all but the proposed critical elements of MC4PD The OT reviews pre-treatment cognitive test scores with the client but without discussion to build awareness The OT selects treatment activities based on the clients cognitive profile and goals from a published set of activities designed for use in cognitive interventions Graded task practice with OT feedback on performance accuracy is used to produce neurocognitive improvement or possibly independent strategy development The OT assigns practice of specific cognitively challenging everyday life activities for homework but without action plans
Participants will complete assessments related to cognition goal-attainment participation one-week and three-months post-treatment sessions
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