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Cognitive Rehabilitation for PD (CogSMART-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335150
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: CogSMART-PD Behavioral: Supportive Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator and Assessor are blinded to group assignment.
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI
Actual Study Start Date : November 2, 2015
Actual Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Supportive Care
Support Group for PD-MCI
Behavioral: Supportive Care
Support Group for persons with PD-MCI

Experimental: CogSMART-PD
Cognitive Rehabilitation for PD-MCI
Behavioral: CogSMART-PD
Cognitive Rehabilitation for persons with PD-MCI




Primary Outcome Measures :
  1. Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score [ Time Frame: Baseline and Week 10 ]
    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 :
  1. Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score [ Time Frame: Baseline and Week 10 ]
    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.

  2. Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score [ Time Frame: Baseline and Week 10 ]
    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.

  3. Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score [ Time Frame: Baseline and Week 10 ]
    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.

  4. Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score [ Time Frame: Baseline and Week 10 ]
    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.

  5. Memory for Intention Test (MIST) Total Score [ Time Frame: Baseline and Week 10 ]
    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.

  6. World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score [ Time Frame: Baseline and Week 10 ]
    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.

  7. Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score [ Time Frame: Baseline and Week 10 ]
    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.

  8. Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score [ Time Frame: Baseline and Week 10 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335150


Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Dawn M. Schiehser, PhD VA San Diego Healthcare System, San Diego, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03335150    
Other Study ID Numbers: E1691-I
First Posted: November 7, 2017    Key Record Dates
Results First Posted: June 4, 2020
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Parkinson's disease
Rehabilitation
Cognition
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases