Rehabilitation of Everyday Memory Impairment in Parkinson Disease: A Pilot Study (REMI-PD)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prospective Memory Strategy
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Participants will be males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn & Yahr39 stage I-III (mild-moderate disease) and are treated with levodopa/carbidopa.
Exclusion Criteria:
- Possible dementia,
- treatment with certain medications that interfere with cognition (e.g., anticholinergics),
- change in medications over the study period, other neurological disorders, brain surgery (e.g., STN DBS),
- history of psychotic disorder or significant current psychiatric disorder, or any condition that would interfere with testing (e.g., vision problems).
Sites / Locations
- Washington University School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01469741
First Posted
November 8, 2011
Last Updated
June 1, 2015
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01469741
Brief Title
Rehabilitation of Everyday Memory Impairment in Parkinson Disease: A Pilot Study
Acronym
REMI-PD
Official Title
Rehabilitation of Everyday Memory Impairment in Parkinson Disease: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (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
Cognitive impairment is common among non-demented individuals with Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Unfortunately, there are no successful interventions to address these impairments. Prospective memory impairment is a particularly functionally- and clinically-relevant problem in PD. The investigator's project will determine if a targeted intervention strategy improves PD participants' prospective memory. The investigator's goal is to improve PD patients' everyday prospective memory so they can successfully perform desired activities and roles.
Detailed Description
Cognitive impairment is common among non-demented individuals with Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Unfortunately, there are no successful interventions to address these impairments. Prospective memory impairment is a particularly functionally- and clinically-relevant problem in PD. The investigator's project will determine if a targeted intervention strategy improves PD participants' prospective memory. The investigator will use a randomized controlled design and a laboratory-based assessment of prospective memory to test the effect of the strategy in a controlled environment. The investigator will also see if PD participants, with support from an occupational therapist (OT), can generalize the strategy to their complex, real-world environments and tasks. Our goal is to improve PD patients' everyday prospective memory so they can successfully perform desired activities and roles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Prospective Memory Strategy
Intervention Description
Prospective memory is central to performance in everyday life as it serves to bind together goal-directed actions and enables people to carry out their plans and wishes meaningfully and appropriately. Everyday prospective memory tasks include remembering to run errands, keep appointments, and turn off the stove after using it.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants will be males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn & Yahr39 stage I-III (mild-moderate disease) and are treated with levodopa/carbidopa.
Exclusion Criteria:
Possible dementia,
treatment with certain medications that interfere with cognition (e.g., anticholinergics),
change in medications over the study period, other neurological disorders, brain surgery (e.g., STN DBS),
history of psychotic disorder or significant current psychiatric disorder, or any condition that would interfere with testing (e.g., vision problems).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Foster, OTD, OTR/L
Organizational Affiliation
Washington University School of Medicine, Department of Occupational Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation of Everyday Memory Impairment in Parkinson Disease: A Pilot Study
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