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

NCT04048122 | Completed Results

• 1 other identifier: 201906062
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

occupational therapy; cognition

Outcome Measures

Primary Outcomes (1)

• Change in Bangor Goal Setting Interview (BGSI) Goal Attainment

  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.

  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.

Secondary Outcomes (2)

• Client Satisfaction Questionnaire

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

• Treatment Fidelity Scale

  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.

Study Arms (2)

Standard of Care (Control Group)

ACTIVE COMPARATOR

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. 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).

Behavioral: Standard of Care

MC4PD Strategy Training

EXPERIMENTAL

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.

Behavioral: MultiContext for PD Strategy Training

Interventions

MultiContext for PD Strategy Training BEHAVIORAL

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. 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).

MC4PD Strategy Training

Standard of Care BEHAVIORAL

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.

Standard of Care (Control Group)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females over age 40 who meet criteria for typical idiopathic PD (stage I-III)
• Have subjective cognitive decline (SCD) as defined by a positive answer to either question: "Do you feel like your thinking skills or memory are becoming worse?" "Do you have problems with your thinking skills or memory?", and can list one or more daily cognitive challenge they wish to address.
• Medications should be stable for 4 weeks prior with no changes planned during the study (we will document unplanned changes).

You may not qualify if:

• Dementia according to MDS criteria or a Montreal Cognitive Assessment (MoCA) score \< 21
• other neurological disorders
• brain surgery
• history of psychotic disorder
• any condition that would interfere with participation (e.g. non-English speaking, significant current depression)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Washington University School of Medicine, Movement Disorders Center

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Foster ER, Carson L, Jonas J, Kang E, Doty T, Toglia J. The Weekly Calendar Planning Activity to Assess Functional Cognition in Parkinson Disease. OTJR (Thorofare N J). 2022 Oct;42(4):315-323. doi: 10.1177/15394492221104075. Epub 2022 Jun 17.

  PMID: 35713209 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Erin Foster
• Organization: Washington University School of Medicine

erfoster@wustl.edu

314-286-1638

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized to treatment arm: the intervention or the standard of care control. Participants will not be informed if their treatment group is the experimental intervention or standard of care. 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). Members of the research team who are involved in the post-treatment testing will be blinded to which intervention (experimental or control) the study participant received from the trained OT.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to treatment arm (1:1 ratio, stratified by sex): the intervention or the standard of care control. Both arms will consist of 10 individualized treatment sessions within a 12-week period.

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 7, 2019
• Study Start: November 4, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 8, 2024
• Results First Posted: October 6, 2023

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)