Trial Outcomes & Findings for EMPOWER PD - Feasibility of an Interdisciplinary Clinic for People With Parkinson's Disease (NCT NCT05640167)
NCT ID: NCT05640167
Last Updated: 2025-08-01
Results Overview
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.
COMPLETED
NA
19 participants
Baseline and End of Study - 2 Months
2025-08-01
Participant Flow
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.
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EMPOWER PD - Feasibility of an Interdisciplinary Clinic for People With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
EMPOWER PD Clinic Participation
n=19 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
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Age, Categorical
>=65 years
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11 Participants
n=5 Participants
|
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Age, Continuous
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68.53 years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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19 participants
n=5 Participants
|
|
Education level
Up to High School or GED
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2 Participants
n=5 Participants
|
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Education level
Some College or Vocational School
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5 Participants
n=5 Participants
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Education level
College degree
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12 Participants
n=5 Participants
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Years Living with Parkinson's Disease
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6.1 years
STANDARD_DEVIATION 5.45 • n=5 Participants
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Stage of Parkinson's Disease
Early Stage (0-4 years)
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9 Participants
n=5 Participants
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Stage of Parkinson's Disease
Mid Stage (5-10 years)
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6 Participants
n=5 Participants
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Stage of Parkinson's Disease
Adavanced Stage (>10 years)
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4 Participants
n=5 Participants
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Montreal Cognitive Assessment
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26.26 units on a scale
STANDARD_DEVIATION 4.98 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and End of Study - 2 MonthsFeasibility 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.
Outcome measures
| Measure |
EMPOWER PD Clinic Participation
n=19 Participants
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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Feasibility and Accessibility
Attendance 1:1
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19 Participants
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Feasibility and Accessibility
Attendance Clinic
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19 Participants
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Feasibility and Accessibility
Attendance Seminar
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19 Participants
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Feasibility and Accessibility
Attendance Interview
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19 Participants
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Feasibility and Accessibility
Retention Rate
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19 Participants
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Feasibility and Accessibility
Survey Completion Baseline
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18 Participants
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Feasibility and Accessibility
Survey Completion End of study
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18 Participants
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PRIMARY outcome
Timeframe: End of Study - 2 MonthsA 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.
Outcome measures
| Measure |
EMPOWER PD Clinic Participation
n=19 Participants
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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Feasibility: Program Survey
Question 1 - The clinic was located in an area of RI that was accessible to me.
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4.947 units on a scale
Standard Deviation 0.229
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Feasibility: Program Survey
Question 2 - Parking was easy and accessible
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4.947 units on a scale
Standard Deviation 0.229
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Feasibility: Program Survey
Question 3 - The building where I attended the clinic was accessible.
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4.947 units on a scale
Standard Deviation 0.229
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Feasibility: Program Survey
Question 4 - The clinic was well organized.
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4.947 units on a scale
Standard Deviation 0.229
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Feasibility: Program Survey
Question 5 - It was helpful to be seen by the physical therapist.
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4.947 units on a scale
Standard Deviation 0.229
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Feasibility: Program Survey
Question 6 - It was helpful to be seen by the speech language pathologist.
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4.894 units on a scale
Standard Deviation 0.315
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Feasibility: Program Survey
Question 7 - It was helpful to be seen by the nutritionist.
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4.842 units on a scale
Standard Deviation 0.501
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Feasibility: Program Survey
Question 8 - It was helpful to be seen by the pharmacist.
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4.789 units on a scale
Standard Deviation 0.535
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Feasibility: Program Survey
Question 9 - The four-hour educational seminar increased my knowledge
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4.789 units on a scale
Standard Deviation 0.418
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Feasibility: Program Survey
Question 10 - I feel more confident with my ability to access resources in RI
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4.578 units on a scale
Standard Deviation 0.60
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Feasibility: Program Survey
Question 11 - I have made progress on the individual goals I identified during the clinic
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4.368 units on a scale
Standard Deviation 0.683
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Feasibility: Program Survey
Question 12 - Participating in EMPOWER PD added value to my ability to manage my Parkinson's disease
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4.842 units on a scale
Standard Deviation 0.374
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PRIMARY outcome
Timeframe: BaselineParkinson'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.
Outcome measures
| Measure |
EMPOWER PD Clinic Participation
n=19 Participants
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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|---|---|
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Change in Patient Centered Outcome Questionnaire
Pain - Importance
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34.47 score on a scale
Standard Deviation 9.22
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Change in Patient Centered Outcome Questionnaire
Interference with ADLs - Importance
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41.48 score on a scale
Standard Deviation 8.17
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Change in Patient Centered Outcome Questionnaire
Slowness - Importance
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45.53 score on a scale
Standard Deviation 8.39
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Change in Patient Centered Outcome Questionnaire
Walking Problems - Importance
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51.32 score on a scale
Standard Deviation 9.23
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Change in Patient Centered Outcome Questionnaire
Thnking Porblems - Importance
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51.84 score on a scale
Standard Deviation 9.15
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Change in Patient Centered Outcome Questionnaire
Fatigue - Importance
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50.26 score on a scale
Standard Deviation 8.25
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Change in Patient Centered Outcome Questionnaire
Emotional Distress - Importance Emotional Distress - Importance
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33.16 score on a scale
Standard Deviation 8.21
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Change in Patient Centered Outcome Questionnaire
Tremor - Importance
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36.58 score on a scale
Standard Deviation 7.99
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Change in Patient Centered Outcome Questionnaire
Stiffness - Importance
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56.05 score on a scale
Standard Deviation 8.72
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Change in Patient Centered Outcome Questionnaire
Sleep Problems - Importance
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38.95 score on a scale
Standard Deviation 8.57
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PRIMARY outcome
Timeframe: Baseline and End of Study - 2 monthsPopulation: One participant was dropped from the analysis due to cognitive impairment and difficulty completing the 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.
Outcome measures
| Measure |
EMPOWER PD Clinic Participation
n=18 Participants
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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|---|---|
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Parkinson's Disease Knowledge Questionnaire
PDKQ Pre-Assess
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66.03 percentage of correct answers
Standard Deviation 10.23
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Parkinson's Disease Knowledge Questionnaire
PDKQ Post-Assess
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75.21 percentage of correct answers
Standard Deviation 12.32
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PRIMARY outcome
Timeframe: Baseline and End of Study - 2 MonthsPopulation: One participant was dropped from the analysis due to cognitive impairment and difficulty completing the 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").
Outcome measures
| Measure |
EMPOWER PD Clinic Participation
n=18 Participants
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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|---|---|
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Change in Health Education Impact Questionnaire
Social integration and support - Post Assess
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3.37 score on a scale 1 to 5
Standard Deviation .55
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Change in Health Education Impact Questionnaire
Postive engagement - Pre Assess
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3.78 score on a scale 1 to 5
Standard Deviation .85
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Change in Health Education Impact Questionnaire
Postive engagement - Post Assess
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4.18 score on a scale 1 to 5
Standard Deviation .73
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Change in Health Education Impact Questionnaire
Health directed activities - Pre Assess
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3.28 score on a scale 1 to 5
Standard Deviation .4
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Change in Health Education Impact Questionnaire
Health directed activities - Post Assess
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3.58 score on a scale 1 to 5
Standard Deviation .42
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Change in Health Education Impact Questionnaire
Skill and Technique Aquisition - Pre Assess
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3.02 score on a scale 1 to 5
Standard Deviation .21
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Change in Health Education Impact Questionnaire
Skill and Technique Aquisition - Post Assess
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3.32 score on a scale 1 to 5
Standard Deviation .39
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Change in Health Education Impact Questionnaire
Constructive Attitudes - Pre Assess
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3.22 score on a scale 1 to 5
Standard Deviation .38
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Change in Health Education Impact Questionnaire
Constructive Attitudes - Post Assess
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3.67 score on a scale 1 to 5
Standard Deviation .34
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Change in Health Education Impact Questionnaire
Self monitoring and insight - Pre Assess
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3.13 score on a scale 1 to 5
Standard Deviation .20
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Change in Health Education Impact Questionnaire
Self monitoring and insight - Post Assess
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3.48 score on a scale 1 to 5
Standard Deviation .35
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Change in Health Education Impact Questionnaire
Health service navigation - Pre Assess
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3.22 score on a scale 1 to 5
Standard Deviation .34
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Change in Health Education Impact Questionnaire
Health service navigation - Post Assess
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3.47 score on a scale 1 to 5
Standard Deviation .55
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Change in Health Education Impact Questionnaire
Social integration and support - Pre Assess
|
3.14 score on a scale 1 to 5
Standard Deviation .35
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Change in Health Education Impact Questionnaire
Emotional well-being - Pre Assess
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2.93 score on a scale 1 to 5
Standard Deviation .25
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Change in Health Education Impact Questionnaire
Emotional well-being - Post Assess
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2.70 score on a scale 1 to 5
Standard Deviation .52
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SECONDARY outcome
Timeframe: Baseline and End of Study - 2 MonthsPopulation: One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire
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.
Outcome measures
| Measure |
EMPOWER PD Clinic Participation
n=18 Participants
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
|
|---|---|
|
Change in Self-Efficacy for Exercise
Self-Efficacy for Exercise - Pre Assess
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64.82 percentage of agreement with statements
Standard Deviation 20.77
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Change in Self-Efficacy for Exercise
Self-Efficacy for Exercise - Post Assess
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67.10 percentage of agreement with statements
Standard Deviation 20.88
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SECONDARY outcome
Timeframe: Baseline and End of Study - 2 MonthsPopulation: One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire
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%.
Outcome measures
| Measure |
EMPOWER PD Clinic Participation
n=18 Participants
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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|---|---|
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Change in Balance Confidence Measured With the Activities-specific Balance Confidence (ABC) Scale.
ABC Pre Assess
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80.79 percentage of agreement with statements
Standard Deviation 15.41
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Change in Balance Confidence Measured With the Activities-specific Balance Confidence (ABC) Scale.
ABC Post Assess
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85.37 percentage of agreement with statements
Standard Deviation 12.74
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SECONDARY outcome
Timeframe: Baseline and End of Study - 2 MonthsPopulation: One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire
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.
Outcome measures
| Measure |
EMPOWER PD Clinic Participation
n=18 Participants
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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Change in Quality of Life Measured With the Parkinson Disease Questionnaire-39 (PDQ-39)
PDQ-39 SI Pre Assess
|
3.93 score on a scale
Standard Deviation 2.27
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Change in Quality of Life Measured With the Parkinson Disease Questionnaire-39 (PDQ-39)
PDQ-39 SI Post Assess
|
4.22 score on a scale
Standard Deviation 2.60
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SECONDARY outcome
Timeframe: Baseline and End of Study - 2 MonthsPopulation: One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire
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.
Outcome measures
| Measure |
EMPOWER PD Clinic Participation
n=18 Participants
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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Change in the Parkinson's Fatigue Scale (PFS-16).
PFS-16 Pre Assess
|
40.39 score on a scale
Standard Deviation 14.01
|
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Change in the Parkinson's Fatigue Scale (PFS-16).
PFS-16 Post Assess
|
40.67 score on a scale
Standard Deviation 14.39
|
Adverse Events
EMPOWER PD Clinic Participation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Christine Clarkin, Principal Investigator
University of Rhode Island
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place