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| Name | Class |
|---|---|
| Brown University | OTHER |
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This study is a nonrandomized, pilot study of an interdisciplinary, patient-centric model of health care delivery in a "boot camp" style structured clinic for people diagnosed with Parkinson's disease (PwPD). 20 participants will attend a three session EMPOWER PD clinic and a two month follow up interview. The primary objective is to assess feasibility and acceptability of the newly developed clinic intervention as well as individual perception of experience and barriers.
This study is a nonrandomized, pilot study of an interdisciplinary, patient-centric model of health care delivery in a "boot camp" style structured clinic for people diagnosed with Parkinson's disease (PwPD). 20 participants will attend a three session EMPOWER PD clinic and a two month follow up interview.
Participants will receive a comprehensive assessment by each member of an interdisciplinary team including physical therapy, speech therapy, nutrition, social work or psychology, and pharmacy. Participants will return the following week for a half day educational symposium. This is a group format and they will receive a session from each of the disciplines covering topics such as exercise, nutrition, communication, socialization, sleep hygiene, medication management, and coping. The final clinic session will be a one hour 1:1 meeting where individualized recommendations will be provided. A participant identified caregiver is invited/allowed to accompany the participant throughout the assessment and educational process whenever possible however, no information or questionnaires are being collected from them.
The primary objective is to assess feasibility and acceptability of the newly developed clinic intervention as well as individual perception of experience and barriers with data derived from a program survey and semi-structured interview completed two months after clinic completion. Secondary objectives will test patient response to clinic intervention related to self-reported outcome measures (SROs) including Patient Centered Outcome Questionnaire PD, PD Knowledge, quality of life, fatigue, confidence with balance, and self-efficacy for exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMPOWER PD Clinic Participation | Other | All participants will be assigned to the same interdisciplinary clinic and educational intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interdisciplinary Clinic | Behavioral | Interdisciplinary Clinic - assessment and recommendations by Nutrition, Pharmacy, Physical Therapy, and Speech Therapy and Educational Seminar - Parkinson's specific education and resources in group format |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Accessibility | Feasibility is measured by attendance and retention and survey completion rates. Attendance reported for each component of the clinic (clinic, seminar, 1:1 meeting, and follow-up interview). Retention reflects the number of participants that participated in all 4 components. Survey completion rates reflect the number of participants that completed all self report measures at Baseline and End of Study. | Baseline and End of Study - 2 Months |
| Feasibility: Program Survey | A series of 12 statements regarding acceptability, process, barriers, and perception of experience of clinic will be scored by participants on a scale of 1 (disagree) to 5 (agree) with a higher score on each statement indicating more positive outcome. The average response per question is reported below. | End of Study - 2 Months |
| Change in Patient Centered Outcome Questionnaire | Parkinson's Disease (PCOQ-PD) The PCOQ-PD evaluates treatment success and expectations from the patient's perspective across 10 motor and non-motor functional domains grouped into four sections. Patients are asked to rate for each domain with each section: (1) their usual levels of self-defined difficulty over the past week, (2) their success criteria for treatment outcomes, (3) their expectations for their treatment, regardless of their previous treatment experiences, and (4) how important it was for them to see improvement. Participants used a 101-point numerical rating scale to indicate their rating, anchored by 0 ("None") to 100 ("Worst Imaginable") for the first three sections and by 0 ("Not at All Important") to 100 ("Most Important") for the fourth section. The mean response and standard deviation are reported below. | Baseline |
| Parkinson's Disease Knowledge Questionnaire | Knowledge regarding Parkinson's disease as measured by the Parkinson's Disease Knowledge Questionnaire (PDKQ). Participants indicate their knowledge of 26 items related to Parkinson's disease with a true or false response. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Efficacy for Exercise | Self-Efficacy for Exercise scale consists of nine situations (weather, boredom, exercising alone, not pleasurable, too busy, feel tired, stress, depressed) that might effect participation in exercise For each situation, the subject uses the scale from 0 (not confident) to 10 (very confident) to describe their current confidence that they could exercise 3 times a week for 20 minutes each time. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise. Participants total score was then divided by 90 to convert to a percentage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine M Clarkin, PhD | University of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rhode Island - Physical Therapy Department | Kingston | Rhode Island | 02881 | United States |
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Twenty-three individuals were screened for the clinic. Two were unable to attend due to limited weekend availability of the clinic, a third could not attend due to geographic/driving barriers, and the remaining 20 were confirmed to attend the EMPOWER PD Clinic in one of two locations offered. One individual was a no show to the clinic resulting in 19 participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | EMPOWER PD Clinic Participation | All participants were assigned to the same interdisciplinary clinic and educational intervention. Interdisciplinary Clinic: Interdisciplinary Clinic - assessment and recommendations by Nutrition, Pharmacy, Physical Therapy, and Speech Therapy and Educational Seminar - Parkinson's specific education and resources in group format |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EMPOWER PD Clinic Participation | All participants were assigned to the same interdisciplinary clinic and educational intervention Interdisciplinary Clinic: Interdisciplinary Clinic - assessment and recommendations by Nutrition, Pharmacy, Physical Therapy, and Speech Therapy and Educational Seminar - Parkinson's specific education and resources in group format |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Feasibility and Accessibility | Feasibility is measured by attendance and retention and survey completion rates. Attendance reported for each component of the clinic (clinic, seminar, 1:1 meeting, and follow-up interview). Retention reflects the number of participants that participated in all 4 components. Survey completion rates reflect the number of participants that completed all self report measures at Baseline and End of Study. | Posted | Count of Participants | Participants | Baseline and End of Study - 2 Months |
|
4 months
Other adverse event would include events that occurred during the time participants were actively engaged in the clinic or educational intervention such as falls or any other reported medical event.
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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 | EMPOWER PD Clinic Participation | All participants were assigned to the same interdisciplinary clinic and educational intervention Interdisciplinary Clinic: Interdisciplinary Clinic - assessment and recommendations by Nutrition, Pharmacy, Physical Therapy, and Speech Therapy and Educational Seminar - Parkinson's specific education and resources in group format |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Christine Clarkin, Principal Investigator | University of Rhode Island | 4018742998 | chrisclarkin@uri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol and Statistical Analysis Plan | Jul 14, 2024 | Jul 14, 2024 | Prot_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan Original | Mar 2, 2023 | May 30, 2025 | Prot_SAP_001.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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| Baseline and End of Study - 2 months |
| Change in Health Education Impact Questionnaire | Subjects score 42 items across 8 domains using a Likert-style question format indicated their strength of agreement by checking an option from 1 ("strongly disagree") through 5 ("strongly agree"). | Baseline and End of Study - 2 Months |
| Baseline and End of Study - 2 Months |
| Change in Balance Confidence Measured With the Activities-specific Balance Confidence (ABC) Scale. | The ABC is The ABC is an 16 question survey and ratings should consist of whole numbers (0-100) for each item. Total the ratings (possible range = 0 - 1600) and divide by 16 to get each subject's ABC score which is a percentage of agreement out of 100%. | Baseline and End of Study - 2 Months |
| Change in Quality of Life Measured With the Parkinson Disease Questionnaire-39 (PDQ-39) | The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month covering 8 dimensions scored on a 5 point ordinal system (0=never, 4=always). Dimension score = sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better QoL. Overall score can be summarized in the Parkinson's Disease Summary Index (PDSI) or PDQ-39 Summary Index (PDQ-39 SI).PDSI or PDQ-39 SI = sum of dimension total scores divided by 8 which then reflects a mean score ranging from 0 to 19.5 with a lower number reflecting better quality of life. | Baseline and End of Study - 2 Months |
| Change in the Parkinson's Fatigue Scale (PFS-16). | The PFS-16 is a 16-item patient rated scale based on feelings and experiences over the past two weeks. Seven items tap the presence or absence of the subjective experience of fatigue with an emphasis on the physical effects of fatigue and nine items address the impact of fatigue on daily functioning and activities, including socialization and work but not exercise specifically. Scoring options range from 1 ("strongly disagree") to 5 (strongly agree"). A total ordinal PFS score ranging from 16-80 based on the sum of the scores will be used. | Baseline and End of Study - 2 Months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education level | Count of Participants | Participants |
|
| Years Living with Parkinson's Disease | This is the number of years an individual had been living with Parkinson's disease based on the year they were diagnosed by a physician. This self reported by the participant and collected during the intake process. | Mean | Standard Deviation | years |
|
| Stage of Parkinson's Disease | The number of years living with Parkinson's disease was used to categorize what stage of the disease an individual was in. Early stage was defined as 0-4 years, mid stage was 5-10 years, and advanced was greater than 10 years. | Count of Participants | Participants |
|
| Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) is a cognitive screen to assess baseline cognitive level across several domains. MOCA scale is scored from 0 (lowest cognitive functioning) to 28 (highest cognitive functioning) with a cut off score of <26 to detect Mild cognitive impairment. This was collected during the interdisciplinary clinic component. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Feasibility: Program Survey | A series of 12 statements regarding acceptability, process, barriers, and perception of experience of clinic will be scored by participants on a scale of 1 (disagree) to 5 (agree) with a higher score on each statement indicating more positive outcome. The average response per question is reported below. | Posted | Mean | Standard Deviation | units on a scale | End of Study - 2 Months |
|
|
|
| Primary | Change in Patient Centered Outcome Questionnaire | Parkinson's Disease (PCOQ-PD) The PCOQ-PD evaluates treatment success and expectations from the patient's perspective across 10 motor and non-motor functional domains grouped into four sections. Patients are asked to rate for each domain with each section: (1) their usual levels of self-defined difficulty over the past week, (2) their success criteria for treatment outcomes, (3) their expectations for their treatment, regardless of their previous treatment experiences, and (4) how important it was for them to see improvement. Participants used a 101-point numerical rating scale to indicate their rating, anchored by 0 ("None") to 100 ("Worst Imaginable") for the first three sections and by 0 ("Not at All Important") to 100 ("Most Important") for the fourth section. The mean response and standard deviation are reported below. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Parkinson's Disease Knowledge Questionnaire | Knowledge regarding Parkinson's disease as measured by the Parkinson's Disease Knowledge Questionnaire (PDKQ). Participants indicate their knowledge of 26 items related to Parkinson's disease with a true or false response. | One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire | Posted | Mean | Standard Deviation | percentage of correct answers | Baseline and End of Study - 2 months |
|
|
|
|
| Primary | Change in Health Education Impact Questionnaire | Subjects score 42 items across 8 domains using a Likert-style question format indicated their strength of agreement by checking an option from 1 ("strongly disagree") through 5 ("strongly agree"). | One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire | Posted | Mean | Standard Deviation | score on a scale 1 to 5 | Baseline and End of Study - 2 Months |
|
|
|
|
| Secondary | Change in Self-Efficacy for Exercise | Self-Efficacy for Exercise scale consists of nine situations (weather, boredom, exercising alone, not pleasurable, too busy, feel tired, stress, depressed) that might effect participation in exercise For each situation, the subject uses the scale from 0 (not confident) to 10 (very confident) to describe their current confidence that they could exercise 3 times a week for 20 minutes each time. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise. Participants total score was then divided by 90 to convert to a percentage. | One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire | Posted | Mean | Standard Deviation | percentage of agreement with statements | Baseline and End of Study - 2 Months |
|
|
|
|
| Secondary | Change in Balance Confidence Measured With the Activities-specific Balance Confidence (ABC) Scale. | The ABC is The ABC is an 16 question survey and ratings should consist of whole numbers (0-100) for each item. Total the ratings (possible range = 0 - 1600) and divide by 16 to get each subject's ABC score which is a percentage of agreement out of 100%. | One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire | Posted | Mean | Standard Deviation | percentage of agreement with statements | Baseline and End of Study - 2 Months |
|
|
|
|
| Secondary | Change in Quality of Life Measured With the Parkinson Disease Questionnaire-39 (PDQ-39) | The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month covering 8 dimensions scored on a 5 point ordinal system (0=never, 4=always). Dimension score = sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better QoL. Overall score can be summarized in the Parkinson's Disease Summary Index (PDSI) or PDQ-39 Summary Index (PDQ-39 SI).PDSI or PDQ-39 SI = sum of dimension total scores divided by 8 which then reflects a mean score ranging from 0 to 19.5 with a lower number reflecting better quality of life. | One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Study - 2 Months |
|
|
|
|
| Secondary | Change in the Parkinson's Fatigue Scale (PFS-16). | The PFS-16 is a 16-item patient rated scale based on feelings and experiences over the past two weeks. Seven items tap the presence or absence of the subjective experience of fatigue with an emphasis on the physical effects of fatigue and nine items address the impact of fatigue on daily functioning and activities, including socialization and work but not exercise specifically. Scoring options range from 1 ("strongly disagree") to 5 (strongly agree"). A total ordinal PFS score ranging from 16-80 based on the sum of the scores will be used. | One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Study - 2 Months |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| Question 4 - The clinic was well organized. |
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| Question 5 - It was helpful to be seen by the physical therapist. |
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| Question 6 - It was helpful to be seen by the speech language pathologist. |
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| Question 7 - It was helpful to be seen by the nutritionist. |
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| Question 8 - It was helpful to be seen by the pharmacist. |
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| Question 9 - The four-hour educational seminar increased my knowledge |
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| Question 10 - I feel more confident with my ability to access resources in RI |
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| Question 11 - I have made progress on the individual goals I identified during the clinic |
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| Question 12 - Participating in EMPOWER PD added value to my ability to manage my Parkinson's disease |
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| Interference with ADLs - Importance |
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| Tremor - Importance |
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| Stiffness - Importance |
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| Slowness - Importance |
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| Walking Problems - Importance |
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| Thnking Porblems - Importance |
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| Sleep Problems - Importance |
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| Health directed activities - Post Assess |
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| Skill and Technique Aquisition - Pre Assess |
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| Skill and Technique Aquisition - Post Assess |
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| Constructive Attitudes - Pre Assess |
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| Constructive Attitudes - Post Assess |
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| Self monitoring and insight - Pre Assess |
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| Self monitoring and insight - Post Assess |
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| Health service navigation - Pre Assess |
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| Health service navigation - Post Assess |
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| Social integration and support - Pre Assess |
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| Social integration and support - Post Assess |
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| Emotional well-being - Pre Assess |
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| Emotional well-being - Post Assess |
|