Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Rehabilitation, Cognition
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.
Interventions
BEHAVIORALCogSMART-PD
Cognitive Rehabilitation for persons with PD-MCI
BEHAVIORALSupportive Care
Support Group for persons with PD-MCI
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigator and Assessor are blinded to group assignment.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supportive Care Support Group for PD
Supportive Care: Support Group for persons with PD | 54 |
| CogSMART-PD Cognitive Rehabilitation for PD
CogSMART-PD: Cognitive Rehabilitation for persons with PD | 55 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 10 | 4 |
Baseline characteristics
| Characteristic | Total | Supportive Care | CogSMART-PD |
|---|---|---|---|
| Age, Continuous | 69.39 years STANDARD_DEVIATION 7.6 | 70.59 years STANDARD_DEVIATION 7.06 | 68.22 years STANDARD_DEVIATION 7.98 |
| Baseline Medication | 725.09 milligrams STANDARD_DEVIATION 464.46 | 685.26 milligrams STANDARD_DEVIATION 445.71 | 764.17 milligrams STANDARD_DEVIATION 483.1 |
| Cognitive Status Mild Cognitive Impairment | 85 Participants | 40 Participants | 45 Participants |
| Cognitive Status Normal Cognition | 23 Participants | 14 Participants | 9 Participants |
| Duration of Disease | 71.18 months STANDARD_DEVIATION 50.68 | 69.02 months STANDARD_DEVIATION 55.97 | 73.27 months STANDARD_DEVIATION 45.43 |
| Education | 15.97 years STANDARD_DEVIATION 2.34 | 16.15 years STANDARD_DEVIATION 2.41 | 15.8 years STANDARD_DEVIATION 2.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants | 50 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Motor Symptoms | 12.01 seconds STANDARD_DEVIATION 4.3 | 12.28 seconds STANDARD_DEVIATION 4.85 | 11.76 seconds STANDARD_DEVIATION 3.73 |
| Race/Ethnicity, Customized Race American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White or Caucasian | 98 Participants | 49 Participants | 49 Participants |
| Sex: Female, Male Female | 32 Participants | 20 Participants | 12 Participants |
| Sex: Female, Male Male | 77 Participants | 34 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 1 / 55 |
Outcome results
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.
Time frame: Baseline and Week 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score | 0.22 score on a scale | Standard Deviation 2.35 |
| CogSMART-PD | Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score | 0.42 score on a scale | Standard Deviation 2.43 |
p-value: 0.6662Mixed Models Analysis
p-value: 0.1617Mixed Models Analysis
p-value: 0.6236Mixed Models Analysis
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.
Time frame: Baseline and Week 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score | -0.24 score on a scale | Standard Deviation 11.16 |
| CogSMART-PD | Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score | 10.17 score on a scale | Standard Deviation 16.96 |
p-value: 0.001Mixed Models Analysis
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.
Time frame: Baseline and Week 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score | -0.09 score on a scale | Standard Deviation 2.7 |
| CogSMART-PD | Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score | 1.06 score on a scale | Standard Deviation 3.15 |
p-value: 0.0496Mixed Models Analysis
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.
Time frame: Baseline and Week 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score | -4.49 score on a scale | Standard Deviation 7.03 |
| CogSMART-PD | Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score | -10.46 score on a scale | Standard Deviation 12.55 |
p-value: 0.02Mixed Models Analysis
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.
Time frame: Baseline and Week 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score | -5.51 score on a scale | Standard Deviation 7.84 |
| CogSMART-PD | Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score | -8.86 score on a scale | Standard Deviation 8.19 |
p-value: 0.047Mixed Models Analysis
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.
Time frame: Baseline and Week 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Memory for Intention Test (MIST) Total Score | 4 score on a scale | Standard Deviation 5.43 |
| CogSMART-PD | Memory for Intention Test (MIST) Total Score | 2.82 score on a scale | Standard Deviation 6.87 |
p-value: 0.444Mixed Models Analysis
p-value: 0.0233Mixed Models Analysis
p-value: <0Mixed Models Analysis
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.
Time frame: Baseline and Week 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score | 1.82 score on a scale | Standard Deviation 6.63 |
| CogSMART-PD | Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score | -2.30 score on a scale | Standard Deviation 9.15 |
p-value: 0.0263Mixed Models Analysis
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.
Time frame: Baseline and Week 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score | -2.31 score on a scale | Standard Deviation 11.56 |
| CogSMART-PD | Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score | -2.69 score on a scale | Standard Deviation 10.27 |
p-value: 0.82Mixed Models Analysis
p-value: 0.0257Mixed Models Analysis
p-value: 0.1101Mixed Models Analysis
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.
Time frame: Baseline and Week 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score | 4.02 score on a scale | Standard Deviation 11.6 |
| CogSMART-PD | World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score | 0.04 score on a scale | Standard Deviation 9.85 |
p-value: 0.073Mixed Models Analysis