Cognitive Rehabilitation for PD

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Behavioral: Supportive Care; Behavioral: CogSMART-PD

• Registration Number: NCT03335150
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2015-11-02
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-07
• Primary Completion: 2019-04-30
• Results First Submitted: 2020-05-01
• Results First Submitted QC: 2020-05-22
• Results First Posted: 2020-06-04
• Study Completion: 2021-01-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Care	Supportive Care	Support Group for PD-MCI
CogSMART-PD	CogSMART-PD	Cognitive Rehabilitation for PD-MCI

Primary Outcome Measures

Name	Time	Method
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score	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

Name	Time	Method
Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score	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.
Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score	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.
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score	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.
Memory for Intention Test (MIST) Total Score	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.
World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score	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.
Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score	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.
Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score	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.
Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score	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.

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States