Cognitive Rehabilitation for PD

Study Overview
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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.

Official Title
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Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: CogSMART-PD
* Behavioral: Supportive Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supportive Care<br>Support Group for PD-MCI | Behavioral: Supportive Care<br>* Support Group for persons with PD-MCI<br>|
| Experimental: CogSMART-PD<br>Cognitive Rehabilitation for PD-MCI | Behavioral: CogSMART-PD<br>* Cognitive Rehabilitation for persons with PD-MCI<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Rehabilitation, Cognition