Cognitive Rehabilitation for PD

Parkinson's Disease Clinical Trial

— CogSMART-PD  

Official title:

Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335150
• Other study ID #: E1691-I
• Status: Completed
• Phase: N/A
• Start date: November 2, 2015
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 31, 2021
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• CogSMART-PD
Cognitive Rehabilitation for persons with PD-MCI
• Supportive Care
Support Group for persons with PD-MCI

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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