Cognitive Rehabilitation for PD (CogSMART-PD)

Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI

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

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: Supportive Care; Behavioral: CogSMART-PD

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 10
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.	Baseline and Week 10
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.	Baseline and Week 10
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.	Baseline and Week 10
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.	Baseline and Week 10
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.	Baseline and Week 10
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.	Baseline and Week 10
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.	Baseline and Week 10

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2015
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): January 31, 2021

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (ACTUAL): November 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Cognition; Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: E1691-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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