Cognitive Rehabilitation for PD

NCT ID: NCT03335150

Last Updated: 2021-02-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-02

Study Completion Date

2021-01-31

Brief Summary

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To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI).

Detailed Description

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Eligible study participants will be randomly assigned to one of two interventions: 1) Cognitive Rehabilitation (Cognitive Symptom Management and Rehabilitation Therapy for Parkinson's disease; CogSMART-PD) or 2) Supportive Care. Interventions are held within a group format consisting of approximately 5 individuals with PD. Groups will meet once per week for 1.5 hours over a 10-week period. Neuropsychological testing will be administered pre- and post-intervention as well as 6- and 12-months after the intervention.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator and Assessor are blinded to group assignment.

Study Groups

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Supportive Care

Support Group for PD-MCI

Group Type ACTIVE_COMPARATOR

Supportive Care

Intervention Type BEHAVIORAL

Support Group for persons with PD-MCI

CogSMART-PD

Cognitive Rehabilitation for PD-MCI

Group Type EXPERIMENTAL

CogSMART-PD

Intervention Type BEHAVIORAL

Cognitive Rehabilitation for persons with PD-MCI

Interventions

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CogSMART-PD

Cognitive Rehabilitation for persons with PD-MCI

Intervention Type BEHAVIORAL

Supportive Care

Support Group for persons with PD-MCI

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Parkinson's disease
2. Mild Cognitive Impairment
3. Over 40 years of age
4. Fluent English speaker

Exclusion Criteria

Other neurological conditions (e.g., stroke) besides Parkinson's disease
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dawn M. Schiehser, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

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VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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E1691-I

Identifier Type: -

Identifier Source: org_study_id

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