Self-Reports of Executive Functions in Persons With Parkinson's Disease and Their Significant Others

June 15, 2021 updated by: Jane Roitsch, Old Dominion University

The investigators are conducting a study to compare the self-reports of executive functions (that is to say, what role cognitive processes such as working memory and attention) in persons with Parkinson's Disease to the reports of executive functions completed by their significant others.

To conduct this study, the investigators need the participation of persons who are diagnosed with Parkinson's Disease and their significant others.

Study Overview

Status

Recruiting

Detailed Description

The purpose of this study is to explore the relationship between the self-reported executive functions (EFs) in persons with Parkinsons disease (PD) and their significant others. Executive functions include basic cognitive processes such as attention, inhibition, working memory, and cognitive flexibility. As this proposed study will test not only cognitive functioning, but specific aspects of it (i.e., EFs) without excluding persons with PD who have identified cognitive impairments, outcomes gathered could provide valuable information to better assist all types of persons with PD. Comparing their self-reported EFs to the EF ratings completedy by their signifiant others can help determine if a disparity exists between self-perceptions and actual observed EF abilties. This study would assess EFs through inhibition responses of participants via computerized versions the Comprehensive Executive Function Inventory-Adult Self-Report and Observer forms.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Virginia
      • Norfolk, Virginia, United States, 23508
        • Recruiting
        • Old Dominion University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parkinson's group: Adults with a Parkinson's disease diagnosis and their significant others.

Healthy elderly: no history of neurologic disease (e.g., stroke, traumatic brain injury)

Both groups:

Age 30-79 years with no history of other neurologic diseases, orthopedic, or arthritic conditions that preclude ability to walk

Some of the earliest cognitive symptoms of Parkinsonism involve executive function deficits (e.g., working memory, cognitive flexibility, planning; Williams-Gray, Foltynie, Lewis, and Barker, 2006). What is less understood, however, is whether a relationship exists between the self-reported EFs in persons with Parkinsonism and their significant others. The need for research to investigate the relationship between EFs in persons with Parkinsonism is evident in the limited body of literature currently available.

Description

Inclusion Criteria:

  • For persons with PD,confirmed diagnosis of PD) For significant others - relationship with person with PD

Exclusion Criteria:All participants will be screened to ensure they do not have:

  • any known cognitive disorders other than those associated with PD
  • impairments in vision that would affect their ability to safely participate in the study
  • recent history of neuromuscular injury/ damage that could affect their ability to complete the CEFI
  • the participant will be excluded if he or she is unable to follow commands well enough to complete the CEFI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Persons with PD
Adults with PD will be provided with email link to complete the Comprehensive Executive Function Inventory-Self-Assessment
Significant Others of those with PD
Adults whose significant other has a diagnosis of PD will be provided with email link to complete the Comprehensive Executive Function Inventory-Observer report

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of EF outcomes
Time Frame: 1 year
Results of the self-reports of persons with PD and their Significant Others will be compared.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Anticipated)

June 8, 2022

Study Completion (Anticipated)

June 8, 2022

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No other researchers will received participant data information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinsonism or Parkinson's Disease Nos

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