Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04048122 |
| Other study ID # |
201906062 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 4, 2019 |
| Est. completion date |
July 1, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Parkinson disease (PD) affects over 1 million Americans and causes considerable personal and
socioeconomic costs (>$34 billion/year 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 MC4PD's 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.
Description:
Parkinson disease (PD) affects over 1 million Americans and causes considerable personal and
socioeconomic costs (>$34 billion/year 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 MC4PD's 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
participants/month, retention in both treatment groups will be 4 participants/month,
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%, n=180) 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 MC4PD's 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 and/or 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 (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. 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 client's 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 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. The OT's 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 client's 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 client's 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 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).
Participants will complete assessments related to cognition, goal-attainment, participation
one-week and three-months post-treatment sessions.
