Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04555720
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2020-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kyle.mitchell@duke.edu', 'phone': '919-668-2879', 'title': 'Kyle Mitchell, MD', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Within 3 months of clinic visit', 'description': 'Self-report. Adverse events were not collected for the 2 Caregiver Arms.', 'eventGroups': [{'id': 'EG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.", 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Composite Score on Self-efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '42'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard clinic visit', 'description': 'Title of scale: Self-efficacy Scale for Chronic Diseases. This is a validated scale. Minimum score is 6, Maximum score is 60. Higher score is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.'}, {'type': 'SECONDARY', 'title': 'Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '138.3', 'spread': '186.4', 'groupId': 'OG000'}, {'value': '205.2', 'spread': '147', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard care visit', 'description': 'Investigator developed patient engagement survey', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.'}, {'type': 'SECONDARY', 'title': 'Change in Caregiver Burden Score on Zarit Burden Interview Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interdisciplinary Care - Caregivers', 'description': 'Caregivers for participants in the Interdisciplinary Care arm'}, {'id': 'OG001', 'title': 'Standard of Care - Caregivers', 'description': 'Caregivers for participants in the standard of care arm'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard care visit', 'description': 'Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only care partners were analyzed'}, {'type': 'SECONDARY', 'title': 'Number of Skilled Therapy Visits as Reported by Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '9', 'spread': '23.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard care visit', 'description': 'Number of skilled therapy visits as reported by participant', 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3-6 months after interdisciplinary or standard care visit', 'description': 'Number of participants with a hospitalization as reported by participant and medical record review', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an ER Visit as Reported by Participant and Medical Record Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3-6 months after interdisciplinary or standard care visit', 'description': 'Number of participants with an ER visit as reported by participant and medical record review', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.'}, {'type': 'SECONDARY', 'title': 'Number Participants With a Fall as Reported by Participant and Medical Record Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard care visit', 'description': 'Number participants with a fall as reported by Participant and Medical Record Review', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3-6 months after interdisciplinary or standard care visit', 'description': 'Number of participants with a contraindicated medication combination as determined by medical record review', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations."}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}, {'id': 'FG002', 'title': 'Interdisciplinary Care - Caregivers', 'description': 'Caregivers for participants in the Interdisciplinary Care arm'}, {'id': 'FG003', 'title': 'Standard of Care - Caregivers', 'description': 'Caregivers for participants in the standard of care arm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.\n\nInterdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations."}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}, {'id': 'BG002', 'title': 'Interdisciplinary Care - Caregivers', 'description': 'Caregivers for participants in the Interdisciplinary Care arm'}, {'id': 'BG003', 'title': 'Standard of Care - Caregivers', 'description': 'Caregivers for participants in the standard of care arm'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '10.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age of participants in the 2 Caregiver arms was not collected'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex was not collected for participants in the 2 Caregiver arms'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity of participants in the 2 Caregiver arms was not collected'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race of participants in the 2 Caregiver Arms was not collected'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Only participants in the Interdisciplinary Care and Standard of Care Arms who completed the study are included. Baseline demographic information was not collected from the 2 Caregiver Arms.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-29', 'size': 156728, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-11T15:05', 'hasProtocol': True}, {'date': '2020-09-16', 'size': 179116, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-11T15:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2020-09-14', 'resultsFirstSubmitDate': '2023-07-11', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-14', 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Composite Score on Self-efficacy Scale', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard clinic visit', 'description': 'Title of scale: Self-efficacy Scale for Chronic Diseases. This is a validated scale. Minimum score is 6, Maximum score is 60. Higher score is a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey.', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard care visit', 'description': 'Investigator developed patient engagement survey'}, {'measure': 'Change in Caregiver Burden Score on Zarit Burden Interview Scale', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard care visit', 'description': 'Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome.'}, {'measure': 'Number of Skilled Therapy Visits as Reported by Participant', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard care visit', 'description': 'Number of skilled therapy visits as reported by participant'}, {'measure': 'Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review', 'timeFrame': 'Baseline, 3-6 months after interdisciplinary or standard care visit', 'description': 'Number of participants with a hospitalization as reported by participant and medical record review'}, {'measure': 'Number of Participants With an ER Visit as Reported by Participant and Medical Record Review', 'timeFrame': 'Baseline, 3-6 months after interdisciplinary or standard care visit', 'description': 'Number of participants with an ER visit as reported by participant and medical record review'}, {'measure': 'Number Participants With a Fall as Reported by Participant and Medical Record Review', 'timeFrame': 'Baseline, 3 months after interdisciplinary or standard care visit', 'description': 'Number participants with a fall as reported by Participant and Medical Record Review'}, {'measure': 'Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review', 'timeFrame': 'Baseline, 3-6 months after interdisciplinary or standard care visit', 'description': 'Number of participants with a contraindicated medication combination as determined by medical record review'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interdisciplinary care', 'patient engagement', 'preventative care'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if an interdisciplinary clinic can help people with Parkinson's disease care for themselves, improve their ability to follow recommended treatments, and have fewer problems like falls or visits to the emergency room.\n\nParticipants will be randomly assigned to receive either care from the interdisciplinary clinic or standard neurological specialist care.\n\nThis study involves questionnaires both before and 3 months after participation in a one time interdisciplinary care clinic or standard care depending on which type of care the participant is randomized to. Participants will be in the study for up to 6 months. The study will end upon completion of questionnaires about 3 months after treatment with the interdisciplinary care clinic or standard care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Parkinson's Disease over the age of 30,\n* Caregiver willing to also participate.\n* Must be able to provide consent.\n\nExclusion Criteria:\n\n-Atypical Parkinsonism"}, 'identificationModule': {'nctId': 'NCT04555720', 'briefTitle': 'The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease', 'orgStudyIdInfo': {'id': 'Pro00105281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interdisciplinary Care', 'description': "If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.", 'interventionNames': ['Behavioral: Interdisciplinary Visit']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.'}], 'interventions': [{'name': 'Interdisciplinary Visit', 'type': 'BEHAVIORAL', 'description': 'If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.', 'armGroupLabels': ['Interdisciplinary Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Kyle Mitchell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}