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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.
Participants will be randomly assigned to receive either care from the interdisciplinary clinic or standard neurological specialist care.
This 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interdisciplinary Care | Experimental | 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. |
|
| Standard of Care | No Intervention | If assigned to standard of care, group participants will have a normally scheduled visit with neurologist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interdisciplinary Visit | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Composite Score on Self-efficacy Scale | 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. | Baseline, 3 months after interdisciplinary or standard clinic visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey. | Investigator developed patient engagement survey | Baseline, 3 months after interdisciplinary or standard care visit |
| Change in Caregiver Burden Score on Zarit Burden Interview Scale |
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Inclusion Criteria:
Exclusion Criteria:
-Atypical Parkinsonism
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Mitchell, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interdisciplinary Care | 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. Interdisciplinary 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. |
| FG001 | Standard of Care | If assigned to standard of care, group participants will have a normally scheduled visit with neurologist. |
| FG002 | Interdisciplinary Care - Caregivers | Caregivers for participants in the Interdisciplinary Care arm |
| FG003 | Standard of Care - Caregivers | Caregivers for participants in the standard of care arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Interdisciplinary Care | 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. Interdisciplinary 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of participants in the 2 Caregiver arms was not collected |
| 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 | Change in Composite Score on Self-efficacy Scale | 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. | Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 3 months after interdisciplinary or standard clinic visit |
|
Within 3 months of clinic visit
Self-report. Adverse events were not collected for the 2 Caregiver Arms.
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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 | Interdisciplinary Care | 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. Interdisciplinary 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyle Mitchell, MD | Duke University Medical Center | 919-668-2879 | kyle.mitchell@duke.edu |
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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 29, 2021 | Jul 11, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2020 | Jul 11, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome. |
| Baseline, 3 months after interdisciplinary or standard care visit |
| Number of Skilled Therapy Visits as Reported by Participant | Number of skilled therapy visits as reported by participant | Baseline, 3 months after interdisciplinary or standard care visit |
| Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review | Number of participants with a hospitalization as reported by participant and medical record review | Baseline, 3-6 months after interdisciplinary or standard care visit |
| Number of Participants With an ER Visit as Reported by Participant and Medical Record Review | Number of participants with an ER visit as reported by participant and medical record review | Baseline, 3-6 months after interdisciplinary or standard care visit |
| Number Participants With a Fall as Reported by Participant and Medical Record Review | Number participants with a fall as reported by Participant and Medical Record Review | Baseline, 3 months after interdisciplinary or standard care visit |
| Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review | Number of participants with a contraindicated medication combination as determined by medical record review | Baseline, 3-6 months after interdisciplinary or standard care visit |
| Withdrawal by Subject |
|
| BG001 | Standard of Care | If assigned to standard of care, group participants will have a normally scheduled visit with neurologist. |
| BG002 | Interdisciplinary Care - Caregivers | Caregivers for participants in the Interdisciplinary Care arm |
| BG003 | Standard of Care - Caregivers | Caregivers for participants in the standard of care arm |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex was not collected for participants in the 2 Caregiver arms | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity of participants in the 2 Caregiver arms was not collected | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race of participants in the 2 Caregiver Arms was not collected | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care | If assigned to standard of care, group participants will have a normally scheduled visit with neurologist. |
|
|
| Secondary | Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey. | Investigator developed patient engagement survey | Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups. | Posted | Mean | Standard Deviation | minutes | Baseline, 3 months after interdisciplinary or standard care visit |
|
|
|
| Secondary | Change in Caregiver Burden Score on Zarit Burden Interview Scale | Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome. | Only care partners were analyzed | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 3 months after interdisciplinary or standard care visit |
|
|
|
| Secondary | Number of Skilled Therapy Visits as Reported by Participant | Number of skilled therapy visits as reported by participant | Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups. | Posted | Mean | Standard Deviation | visits | Baseline, 3 months after interdisciplinary or standard care visit |
|
|
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| Secondary | Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review | Number of participants with a hospitalization as reported by participant and medical record review | Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups. | Posted | Count of Participants | Participants | Baseline, 3-6 months after interdisciplinary or standard care visit |
|
|
|
| Secondary | Number of Participants With an ER Visit as Reported by Participant and Medical Record Review | Number of participants with an ER visit as reported by participant and medical record review | Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups. | Posted | Count of Participants | Participants | Baseline, 3-6 months after interdisciplinary or standard care visit |
|
|
|
| Secondary | Number Participants With a Fall as Reported by Participant and Medical Record Review | Number participants with a fall as reported by Participant and Medical Record Review | Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups. | Posted | Count of Participants | Participants | Baseline, 3 months after interdisciplinary or standard care visit |
|
|
|
| Secondary | Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review | Number of participants with a contraindicated medication combination as determined by medical record review | Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups. | Posted | Count of Participants | Participants | Baseline, 3-6 months after interdisciplinary or standard care visit |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Standard of Care | If assigned to standard of care, group participants will have a normally scheduled visit with neurologist. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |