Trial Outcomes & Findings for Feasibility and Effect of a Strategy-Based Cognitive Intervention for Parkinson Disease (NCT NCT04048122)

Last Updated: 2024-11-08

Results Overview

BGSI is a structured interview schedule was used to record participant ratings of performance and satisfaction in reaching specific goals, and to record additional ratings of goal attainment. This instrument rates goal attainment on a ten point scale (1-10) with a higher score indicating higher goal attainment.

Recruitment status

COMPLETED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

Pre-cognitive treatment intervention; one week post- cognitive treatment intervention (11 to 13 weeks after the pre-cognitive intervention treatment session); and at 3-months follow-up after the post- cognitive treatment treatment session.

Results posted on

2024-11-08

Participant Flow

Participants were recruited between November 2019 and January 2022 from the university movement disorders clinic, other research studies, and the community.

Participant milestones

Participant milestones
Measure	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 MC, but it is therapist-directed, and the OT does not address strategies, metacognition, generalization, or use mediation or action plans. The OT selects treatment activities based on the client's 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).	Multicontext (MC) This treatment focuses on improving functional performance by enhancing the generation and use of strategies-which can be internal (e.g., self-talk, planning) or external (e.g., 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 client's cognitive problems and goals. Treatment sessions consist of a review of prior sessions and learning, homework review, treatment activities, homework provision, and session recap. Each session's treatment activities are selected collaboratively based on the client's goals and preferences and the OT's assessment of the client's 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.
Overall Study STARTED	28	29
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility and Effect of a Strategy-Based Cognitive Intervention for Parkinson Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=28 Participants 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 MC, but it is therapist-directed, and the OT does not address strategies, metacognition, generalization, or use mediation or action plans. The OT selects treatment activities based on the client's 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).	Multicontext (MC) n=29 Participants This treatment focuses on improving functional performance by enhancing the generation and use of strategies-which can be internal (e.g., self-talk, planning) or external (e.g., 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 client's cognitive problems and goals. Treatment sessions consist of a review of prior sessions and learning, homework review, treatment activities, homework provision, and session recap. Each session's treatment activities are selected collaboratively based on the client's goals and preferences and the OT's assessment of the client's 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.	Total n=57 Participants Total of all reporting groups
Age, Continuous	69.3 years STANDARD_DEVIATION 7.7 • n=5 Participants	71 years STANDARD_DEVIATION 6.8 • n=7 Participants	70.2 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Montreal Cognitive Assessment	25 units on a scale STANDARD_DEVIATION 2.7 • n=5 Participants	26 units on a scale STANDARD_DEVIATION 2.2 • n=7 Participants	25.5 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: Pre-cognitive treatment intervention; one week post- cognitive treatment intervention (11 to 13 weeks after the pre-cognitive intervention treatment session); and at 3-months follow-up after the post- cognitive treatment treatment session.

Outcome measures

Outcome measures
Measure	Control n=25 Participants 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 MC, but it is therapist-directed, and the OT does not address strategies, metacognition, generalization, or use mediation or action plans. The OT selects treatment activities based on the client's 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).	Multicontext (MC) n=26 Participants This treatment focuses on improving functional performance by enhancing the generation and use of strategies-which can be internal (e.g., self-talk, planning) or external (e.g., 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 client's cognitive problems and goals. Treatment sessions consist of a review of prior sessions and learning, homework review, treatment activities, homework provision, and session recap. Each session's treatment activities are selected collaboratively based on the client's goals and preferences and the OT's assessment of the client's 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.
Change in Bangor Goal Setting Interview (BGSI) Goal Attainment Pre-treatment	4.5 score on a scale Standard Error .3	4.6 score on a scale Standard Error .3
Change in Bangor Goal Setting Interview (BGSI) Goal Attainment Post-treatment	5.9 score on a scale Standard Error .2	7.4 score on a scale Standard Error .2
Change in Bangor Goal Setting Interview (BGSI) Goal Attainment Follow-up	5.6 score on a scale Standard Error .3	6.9 score on a scale Standard Error .3

SECONDARY outcome

Timeframe: Administered one time, one week post- cognitive treatment intervention.

Assesses client satisfaction with intervention provided one week after the cognitive intervention, approximately 11 to 13 weeks). Scores can range from 0 to 32, with a higher score indicating higher satisfaction with the intervention.

Outcome measures

Outcome measures
Measure	Control n=25 Participants 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 MC, but it is therapist-directed, and the OT does not address strategies, metacognition, generalization, or use mediation or action plans. The OT selects treatment activities based on the client's 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).	Multicontext (MC) n=26 Participants This treatment focuses on improving functional performance by enhancing the generation and use of strategies-which can be internal (e.g., self-talk, planning) or external (e.g., 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 client's cognitive problems and goals. Treatment sessions consist of a review of prior sessions and learning, homework review, treatment activities, homework provision, and session recap. Each session's treatment activities are selected collaboratively based on the client's goals and preferences and the OT's assessment of the client's 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.
Client Satisfaction Questionnaire	28.8 score on a scale Standard Deviation 3	29.3 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Each of the 10 cognitive treatment intervention sessions. These treatment sessions will be 1 to 1.5 hours in length, and be delivered once a week, to be completed within a 12-week time frame.

Population: A random sample of \~3 treatment sessions per participant.

Measures adherence (1=absent, 2=present) and competence (0=absent, 1=little evidence, 2=adequate/proficient) of the therapist to the MC treatment components (Anticipation, Strategy Generation, Task Challenges, Strategy Post Discussion, Strategy Application). Higher scores are better. This will be completed by a blind rater.

Outcome measures

Outcome measures
Measure	Control n=67 Treatment sessions 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 MC, but it is therapist-directed, and the OT does not address strategies, metacognition, generalization, or use mediation or action plans. The OT selects treatment activities based on the client's 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).	Multicontext (MC) n=71 Treatment sessions This treatment focuses on improving functional performance by enhancing the generation and use of strategies-which can be internal (e.g., self-talk, planning) or external (e.g., 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 client's cognitive problems and goals. Treatment sessions consist of a review of prior sessions and learning, homework review, treatment activities, homework provision, and session recap. Each session's treatment activities are selected collaboratively based on the client's goals and preferences and the OT's assessment of the client's 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.
Treatment Fidelity Scale Anticipation Adherence	1.0 Score on fidelity scale Standard Deviation 0	1.8 Score on fidelity scale Standard Deviation .38
Treatment Fidelity Scale Strategy Generation Adherence	1.0 Score on fidelity scale Standard Deviation .03	1.8 Score on fidelity scale Standard Deviation .38
Treatment Fidelity Scale Task Challenges Adherence	1.1 Score on fidelity scale Standard Deviation .15	1.9 Score on fidelity scale Standard Deviation .29
Treatment Fidelity Scale Strategy Post Adherence	1.1 Score on fidelity scale Standard Deviation .23	1.9 Score on fidelity scale Standard Deviation .21
Treatment Fidelity Scale Strategy Application Adherence	1.0 Score on fidelity scale Standard Deviation .10	1.9 Score on fidelity scale Standard Deviation .24
Treatment Fidelity Scale Anticipation Proficiency	0 Score on fidelity scale Standard Deviation .03	1.5 Score on fidelity scale Standard Deviation .77
Treatment Fidelity Scale Strategy Generation Proficiency	0 Score on fidelity scale Standard Deviation .03	1.5 Score on fidelity scale Standard Deviation .75
Treatment Fidelity Scale Task Challenges Proficiency	.05 Score on fidelity scale Standard Deviation .15	1.7 Score on fidelity scale Standard Deviation .60
Treatment Fidelity Scale Strategy Post Proficiency	.09 Score on fidelity scale Standard Deviation .25	1.7 Score on fidelity scale Standard Deviation .49
Treatment Fidelity Scale Strategy Application Proficiency	.02 Score on fidelity scale Standard Deviation .10	1.7 Score on fidelity scale Standard Deviation .47

Adverse Events

Control

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Multicontext (MC)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control n=28 participants at risk 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 MC, but it is therapist-directed, and the OT does not address strategies, metacognition, generalization, or use mediation or action plans. The OT selects treatment activities based on the client's 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).	Multicontext (MC) n=29 participants at risk This treatment focuses on improving functional performance by enhancing the generation and use of strategies-which can be internal (e.g., self-talk, planning) or external (e.g., 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 client's cognitive problems and goals. Treatment sessions consist of a review of prior sessions and learning, homework review, treatment activities, homework provision, and session recap. Each session's treatment activities are selected collaboratively based on the client's goals and preferences and the OT's assessment of the client's 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.
Renal and urinary disorders Acute kidney infection	0.00% 0/28 • For each participant, from their first treatment session to their post-treatment assessment, so up to 13 weeks. Adverse events were only monitored/ assessed up to their post-treatment assessment. At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. In addition, an AE/SAE may occur during a study visit or come to the attention of study personnel in communications with study participants between visits (e.g., calling to cancel an appointment). All events will be captured on the AE/SAE Report Forms.	3.4% 1/29 • Number of events 1 • For each participant, from their first treatment session to their post-treatment assessment, so up to 13 weeks. Adverse events were only monitored/ assessed up to their post-treatment assessment. At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. In addition, an AE/SAE may occur during a study visit or come to the attention of study personnel in communications with study participants between visits (e.g., calling to cancel an appointment). All events will be captured on the AE/SAE Report Forms.

Other adverse events

Other adverse events
Measure	Control n=28 participants at risk 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 MC, but it is therapist-directed, and the OT does not address strategies, metacognition, generalization, or use mediation or action plans. The OT selects treatment activities based on the client's 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).	Multicontext (MC) n=29 participants at risk This treatment focuses on improving functional performance by enhancing the generation and use of strategies-which can be internal (e.g., self-talk, planning) or external (e.g., 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 client's cognitive problems and goals. Treatment sessions consist of a review of prior sessions and learning, homework review, treatment activities, homework provision, and session recap. Each session's treatment activities are selected collaboratively based on the client's goals and preferences and the OT's assessment of the client's 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.
Musculoskeletal and connective tissue disorders Falls	28.6% 8/28 • Number of events 15 • For each participant, from their first treatment session to their post-treatment assessment, so up to 13 weeks. Adverse events were only monitored/ assessed up to their post-treatment assessment. At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. In addition, an AE/SAE may occur during a study visit or come to the attention of study personnel in communications with study participants between visits (e.g., calling to cancel an appointment). All events will be captured on the AE/SAE Report Forms.	51.7% 15/29 • Number of events 42 • For each participant, from their first treatment session to their post-treatment assessment, so up to 13 weeks. Adverse events were only monitored/ assessed up to their post-treatment assessment. At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. In addition, an AE/SAE may occur during a study visit or come to the attention of study personnel in communications with study participants between visits (e.g., calling to cancel an appointment). All events will be captured on the AE/SAE Report Forms.

Additional Information

Dr. Erin Foster

Washington University School of Medicine

Phone: 314-286-1638

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place