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Cognitive Rehabilitation for PD (CogSMART-PD)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CogSMART-PD
Supportive Care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Rehabilitation, Cognition

Eligibility Criteria

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

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Supportive Care

CogSMART-PD

Arm Description

Support Group for PD-MCI

Cognitive Rehabilitation for PD-MCI

Outcomes

Primary Outcome Measures

Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score
The WAIS-IV Matrix Reasoning test is a validated, objective measure of executive function. Scaled scores range from 0 to 26. Higher scores indicate better executive function. Scores reported below are change scores.

Secondary Outcome Measures

Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score
D-KEFS: 20 Questions Test measures executive function. The range of scores is 1 - 19 with a higher score representing better executive function. Scores reported below are change scores.
Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score
The measure examines self-reported change in cognition over time. Scores range from 16 - 80, with higher scores indicating worse functioning (or more cognitive decline). Scores reported below are change scores.
Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score
CPSA measures cognitive problems and memory strategy use. The range for scores is 0 - 90, with higher scores indicating higher frequency of using memory and thinking strategies. Scores reported below are change scores.
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score
IQCODE is a self-report questionnaire for caregivers that measures possible dementia and cognitive decline of the patient. The range for scores is 26 - 130, with higher score representing worse functioning/higher cognitive decline in the patient. Scores reported below are change scores.
Memory for Intention Test (MIST) Total Score
MIST measures prospective memory. The range for scores is 0 - 48 with a higher score representing better prospective memory. Scores reported below are change score.
World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score
WHOQOL-BREF is a self-reported measure of quality of life. Transformed score for the psychological domain ranges from 0 to 100. Higher scores indicate better quality of life. Scores reported below are change scores.
Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score
The PDQ-39 is a patient-reported measure of health and quality life over a 1-month period in individuals with Parkinson's disease. Total scores range from 0 to 156. Higher scores indicate poorer quality of life. Scores reported below are change scores.
Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score
The NPI-Q is a self-reported measure of neuropsychiatric symptoms over a 1 month period and 1 year period. Total month scores range from 0 to 156. Higher scores indicate greater severity of neuropsychiatric symptoms. Scores reported below are change scores.

Full Information

First Posted
October 18, 2017
Last Updated
February 5, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03335150
Brief Title
Cognitive Rehabilitation for PD
Acronym
CogSMART-PD
Official Title
Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2015 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Rehabilitation, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and Assessor are blinded to group assignment.
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care
Arm Type
Active Comparator
Arm Description
Support Group for PD-MCI
Arm Title
CogSMART-PD
Arm Type
Experimental
Arm Description
Cognitive Rehabilitation for PD-MCI
Intervention Type
Behavioral
Intervention Name(s)
CogSMART-PD
Intervention Description
Cognitive Rehabilitation for persons with PD-MCI
Intervention Type
Behavioral
Intervention Name(s)
Supportive Care
Intervention Description
Support Group for persons with PD-MCI
Primary Outcome Measure Information:
Title
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score
Description
The WAIS-IV Matrix Reasoning test is a validated, objective measure of executive function. Scaled scores range from 0 to 26. Higher scores indicate better executive function. Scores reported below are change scores.
Time Frame
Baseline and Week 10
Secondary Outcome Measure Information:
Title
Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score
Description
D-KEFS: 20 Questions Test measures executive function. The range of scores is 1 - 19 with a higher score representing better executive function. Scores reported below are change scores.
Time Frame
Baseline and Week 10
Title
Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score
Description
The measure examines self-reported change in cognition over time. Scores range from 16 - 80, with higher scores indicating worse functioning (or more cognitive decline). Scores reported below are change scores.
Time Frame
Baseline and Week 10
Title
Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score
Description
CPSA measures cognitive problems and memory strategy use. The range for scores is 0 - 90, with higher scores indicating higher frequency of using memory and thinking strategies. Scores reported below are change scores.
Time Frame
Baseline and Week 10
Title
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score
Description
IQCODE is a self-report questionnaire for caregivers that measures possible dementia and cognitive decline of the patient. The range for scores is 26 - 130, with higher score representing worse functioning/higher cognitive decline in the patient. Scores reported below are change scores.
Time Frame
Baseline and Week 10
Title
Memory for Intention Test (MIST) Total Score
Description
MIST measures prospective memory. The range for scores is 0 - 48 with a higher score representing better prospective memory. Scores reported below are change score.
Time Frame
Baseline and Week 10
Title
World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score
Description
WHOQOL-BREF is a self-reported measure of quality of life. Transformed score for the psychological domain ranges from 0 to 100. Higher scores indicate better quality of life. Scores reported below are change scores.
Time Frame
Baseline and Week 10
Title
Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score
Description
The PDQ-39 is a patient-reported measure of health and quality life over a 1-month period in individuals with Parkinson's disease. Total scores range from 0 to 156. Higher scores indicate poorer quality of life. Scores reported below are change scores.
Time Frame
Baseline and Week 10
Title
Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score
Description
The NPI-Q is a self-reported measure of neuropsychiatric symptoms over a 1 month period and 1 year period. Total month scores range from 0 to 156. Higher scores indicate greater severity of neuropsychiatric symptoms. Scores reported below are change scores.
Time Frame
Baseline and Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Parkinson's disease Mild Cognitive Impairment Over 40 years of age Fluent English speaker Exclusion Criteria: Other neurological conditions (e.g., stroke) besides Parkinson's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M. Schiehser, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Rehabilitation for PD

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