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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care | Active Comparator | Support Group for PD-MCI |
|
| CogSMART-PD | Experimental | Cognitive Rehabilitation for PD-MCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CogSMART-PD | Behavioral | Cognitive Rehabilitation for persons with PD-MCI |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other neurological conditions (e.g., stroke) besides Parkinson's disease
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| Name | Affiliation | Role |
|---|---|---|
| Dawn M. Schiehser, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supportive Care | Support Group for PD Supportive Care: Support Group for persons with PD |
| FG001 | CogSMART-PD | Cognitive Rehabilitation for PD CogSMART-PD: Cognitive Rehabilitation for persons with PD |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Supportive Care | Support Group for PD Supportive Care: Support Group for persons with PD |
| BG001 | CogSMART-PD | Cognitive Rehabilitation for PD CogSMART-PD: Cognitive Rehabilitation for persons with PD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started and 2 dropped during group. Therefore, 50 completed measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 10 |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supportive Care | Support Group for PD Supportive Care: Support Group for persons with PD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinical Motor Exam | Surgical and medical procedures | Non-systematic Assessment | Subject was surprised when neurologist administered a standard clinical motor examination to assess balance (UPDRS). As required by the exam, neurologist firmly pulled back on shoulders. Subject reported X-rays with no results. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dawn Schiehser | VASDHS | 858-552-8585 | 2664 | Dawn.Schiehser@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2020 | Apr 30, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Investigator and Assessor are blinded to group assignment.
| Supportive Care |
| Behavioral |
Support Group for persons with PD-MCI |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | The number of years participant received formal education | Mean | Standard Deviation | years |
|
| Duration of Disease | Time from Parkinson's disease diagnosis to enrollment | 54 subjects were enrolled for the Supportive Care group. 1 subject was missing the information. | Mean | Standard Deviation | months |
|
| Cognitive Status | Cognitive status was determined using the Diagnostic Criteria for Mild Cognitive Impairment (Litvan et al., 2012). | 55 subjects were enrolled into the CogSMART-PD group; however, 1 participant did not meet inclusion criteria. | Count of Participants | Participants |
|
| Motor Symptoms | Timed Up and Go (TUG) Test, a motor assessment | 54 subjects were enrolled into the Supportive Care Group; however, 1 subject dropped before their baseline assessment, and 2 were unable to complete the measure in session. 55 subjects were enrolled into the CogSMART-PD group; however, 1 subject was unable to complete the measure in session. | Mean | Standard Deviation | seconds |
|
| Baseline Medication | Amount of Levodopa Equivalent Dose (LED) | 54 subjects enrolled in the Supportive Care group; however, 1 subject's medication info was missing. 55 subjects enrolled in the CogSMART-PD group; however, 1 subject dropped before their baseline assessment. | Mean | Standard Deviation | milligrams |
|
| CogSMART-PD |
Cognitive Rehabilitation for PD CogSMART-PD: Cognitive Rehabilitation for persons with PD |
|
|
|
| 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. | 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started and 2 dropped during group. Therefore, 50 completed measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 1 was missing info. Therefore, 49 completed measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 2 were missing info. Therefore, 48 completed measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group, 5 declined a caregiver, and 1 was missing info. 39 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, 2 were missing info, and 4 declined a caregiver. 44 completed measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started and 2 dropped during group. Therefore, 50 completed measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 1 was missing info. Therefore, 49 completed measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 1 was missing info. Therefore, 49 completed measure. | Posted | Mean | Standard Deviation | score on a scale | 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. | 54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group, 5 declined a caregiver, and 2 were missing info. 38 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, 3 were missing info, and 4 declined a caregiver. 43 completed measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 10 |
|
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | CogSMART-PD | Cognitive Rehabilitation for PD CogSMART-PD: Cognitive Rehabilitation for persons with PD | 0 | 55 | 1 | 55 | 0 | 55 |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Unknown or Not Reported |
|
| Black or African American |
|
| Hispanic or Latino |
|
| Native Hawaiian or Pacific Islander |
|
| White or Caucasian |
|
| Mixed Models Analysis |
There is significant difference in MIST between intervention groups controlling for visit and other significant covariates. |
| 0.0233 |
| Mean Difference (Final Values) |
| 1.145 |
| 2-Sided |
estimated value = SE |
| Other |
Equality |
| Mixed Models Analysis | There is significant difference in MIST between baseline and week 10 controlling for intervention group and other significant covariates | <0.000 | Mean Difference (Final Values) | 0.6281 | 2-Sided | estimated value = SE | Other | Equality |
Mean PDQ-39 difference between baseline and week 10 controlling for intervention and covariates. |
| 0.0257 |
| Mean Difference (Final Values) |
| 1.1172 |
| 2-Sided |
estimated value = SE |
| Other |
Equality |
| Mixed Models Analysis | Difference in PDQ-39 between two interventions controlling for visit and covariates. | 0.1101 | Mean Difference (Final Values) | 3.8649 | 2-Sided | estimated value = SE | Other | Equality |