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Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease (FOCI-PD)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive strategy training
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn & Yahr stage I-III (mild to moderate disease; Hoehn & Yahr, 1967) and are treated with levodopa/carbidopa. For this early phase of development we will limit enrollment to people who can identify at least one daily cognitive performance problem and are willing to learn strategies to address it.

Exclusion Criteria:

  • Possible dementia, medication change over the study period, other neurological disorders, brain surgery (e.g., STN DBS), history of psychotic disorder or significant current psychiatric disorder (i.e., moderate to severe anxiety, apathy or depression), or any condition that would interfere with participation (e.g., non-English speaking). Participants taking benzos will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cognitive strategy training

    Arm Description

    The cognitive strategy training intervention consists of 6 weekly ~1 hour sessions. It is delivered in an individual, face-to-face format in the client's home. It is a behavioral intervention that teaches people metacognitive, problem-solving and other compensatory strategies to address self-identified cognitive performance problems, and it uses practice and homework to promote strategy learning, retention and transfer.

    Outcomes

    Primary Outcome Measures

    Client Satisfaction Questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2016
    Last Updated
    May 23, 2018
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02826785
    Brief Title
    Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease
    Acronym
    FOCI-PD
    Official Title
    Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study investigates the feasibility of a cognitive strategy training intervention for people with Parkinson disease (PD). We plan to recruit 8 non-demented PD participants to complete 6 weekly treatment sessions and Pre- and Post-testing (8 sessions total, entire study duration per participant = 8 weeks). We will measure participant responsiveness and the overall efficiency of the intervention process.
    Detailed Description
    Cognitive impairment is common in Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Existing rehabilitative interventions, which focus on cognitive process training, have not been successful in mitigating its negative functional consequences. We have developed a client-centered cognitive strategy training intervention to enable people with PD to work around their cognitive deficits and maintain their functional performance. This study is an exploratory case series to assess aspects of its feasibility. Specifically, we will assess participant responsiveness to the intervention (acceptance, engagement, adherence), and we will track logistical information (e.g., scheduling). We will also administer an exploratory outcome measure of treatment effect to gain preliminary evidence on the effect of the intervention on self-identified cognitive performance problems. This information will guide modifications and enhancements in preparation for future clinical trials.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive strategy training
    Arm Type
    Experimental
    Arm Description
    The cognitive strategy training intervention consists of 6 weekly ~1 hour sessions. It is delivered in an individual, face-to-face format in the client's home. It is a behavioral intervention that teaches people metacognitive, problem-solving and other compensatory strategies to address self-identified cognitive performance problems, and it uses practice and homework to promote strategy learning, retention and transfer.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive strategy training
    Intervention Description
    The intervention teaches strategies in a way that promotes generalization and enhances daily function . It includes four core elements known to enhance learning transfer: (1) self-generation of broadly applicable strategies, (2) practice across multiple contexts and activities, (3) emphasis on metacognition, and (4) use of meaningful everyday activities.
    Primary Outcome Measure Information:
    Title
    Client Satisfaction Questionnaire
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn & Yahr stage I-III (mild to moderate disease; Hoehn & Yahr, 1967) and are treated with levodopa/carbidopa. For this early phase of development we will limit enrollment to people who can identify at least one daily cognitive performance problem and are willing to learn strategies to address it. Exclusion Criteria: Possible dementia, medication change over the study period, other neurological disorders, brain surgery (e.g., STN DBS), history of psychotic disorder or significant current psychiatric disorder (i.e., moderate to severe anxiety, apathy or depression), or any condition that would interfere with participation (e.g., non-English speaking). Participants taking benzos will be excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erin R Foster, PhD
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease

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