Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease
FOCI-PD
1 other identifier
interventional
8
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started May 2014
Typical duration for not_applicable parkinson-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedMay 24, 2018
May 1, 2018
2 years
June 29, 2016
May 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Client Satisfaction Questionnaire
8 weeks
Study Arms (1)
Cognitive strategy training
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin R Foster, PhD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 11, 2016
Study Start
May 1, 2014
Primary Completion
May 1, 2016
Study Completion
July 1, 2016
Last Updated
May 24, 2018
Record last verified: 2018-05