Parkinson DiseaseNCT05640167

EMPOWER PD - Feasibility of an Interdisciplinary Clinic for People With Parkinson's Disease

A study testing Interdisciplinary Clinic in people with Parkinson Disease, run by University of Rhode Island at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 40 to 100 years
Conditions the study is for: Parkinson Disease
What is being tested?: Interdisciplinary Clinic
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 31 Mar 2023to 30 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A diagnosis of idiopathic Parkinson Disease
Living in the community (not institutionalized)

Who cannot join

A diagnosis of atypical Parkinsonism
Institutionalized (living in a nursing home setting)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rhode Island - Physical Therapy Department
Kingston, Rhode Island, 02881

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Parkinson Disease
Being tested: Interdisciplinary Clinic
Keywords: Patient-centric care, Interdisciplinary care, Parkinson Disease education
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interdisciplinary ClinicBehavioural
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

Study groups in NCT05640167
Study group	Role	What they receive
EMPOWER PD Clinic Participation	Other	All participants will be assigned to the same interdisciplinary clinic and educational intervention Receives: Behavioral: Interdisciplinary Clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: Baseline and End of Study - 2 Months

Secondary outcomes (4)

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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: Baseline and End of Study - 2 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 202330 Jun 2023

First posted7 Dec 2022
Study start31 Mar 2023
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05640167
Sponsor's protocol ID: 1929810-1
Status last verified: Jul 2025
First submitted: 18 Nov 2022
Last updated: 1 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EMPOWER PD - Feasibility of an Interdisciplinary Clinic for People With Parkinson's Disease
ClinicalTrials.gov ID: NCT05640167
Acronym / sponsor ID: 1929810-1
Conditions: Parkinson Disease
Keywords: Patient-centric care, Interdisciplinary care, Parkinson Disease education
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: University of Rhode IslandUniversity, hospital or other
Collaborators: Brown University
Study start: 31 Mar 2023 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 7 Dec 2022 (actual)
Results: Posted 1 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EMPOWER PD Clinic Participation	Other	Behavioral: Interdisciplinary ClinicAll participants will be assigned to the same interdisciplinary clinic and educational intervention

Who may qualify

Ages: 40 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

A diagnosis of idiopathic Parkinson Disease
Living in the community (not institutionalized)

Key exclusion criteria (2 listed)

A diagnosis of atypical Parkinsonism
Institutionalized (living in a nursing home setting)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interdisciplinary ClinicInterdisciplinary Clinic - assessment and recommendations by Nutrition, Pharmacy, Physical Therapy, and Speech Therapy and Educational Seminar - Parkinson's specific education and resources in group format	Behavioural	EMPOWER PD Clinic Participation

Primary outcome

Feasibility and Accessibility
Time frame: Baseline and End of Study - 2 Months
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.
Feasibility: Program Survey
Time frame: End of Study - 2 Months
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.
Change in Patient Centered Outcome Questionnaire
Time frame: Baseline
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.
Parkinson's Disease Knowledge Questionnaire
Time frame: Baseline and End of Study - 2 months
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.
Change in Health Education Impact Questionnaire
Time frame: Baseline and End of Study - 2 Months
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").

4 secondary outcomes

Change in Self-Efficacy for Exercise
Time frame: Baseline and End of Study - 2 Months
Change in Balance Confidence Measured With the Activities-specific Balance Confidence (ABC) Scale.
Time frame: Baseline and End of Study - 2 Months
Change in Quality of Life Measured With the Parkinson Disease Questionnaire-39 (PDQ-39)
Time frame: Baseline and End of Study - 2 Months
Change in the Parkinson's Fatigue Scale (PFS-16).
Time frame: Baseline and End of Study - 2 Months

Results and safety

Results posted to the registry on 1 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EMPOWER PD Clinic Participation	19	19

Primary outcome: Feasibility and Accessibility

Time frame: Baseline and End of Study - 2 Months. Count of participants. Unit: Participants

Measure	EMPOWER PD Clinic Participation n = 19
Attendance Clinic	19
Attendance Seminar	19
Attendance 1:1	19
Attendance Interview	19
Retention Rate	19
Survey Completion Baseline	18
Survey Completion End of study	18

Primary outcome: Feasibility: Program Survey

Time frame: End of Study - 2 Months. Mean (Standard Deviation). Unit: units on a scale

Measure	EMPOWER PD Clinic Participation n = 19
Question 1 - The clinic was located in an area of RI that was accessible to me.	4.947 (0.229)
Question 2 - Parking was easy and accessible	4.947 (0.229)
Question 3 - The building where I attended the clinic was accessible.	4.947 (0.229)
Question 4 - The clinic was well organized.	4.947 (0.229)
Question 5 - It was helpful to be seen by the physical therapist.	4.947 (0.229)
Question 6 - It was helpful to be seen by the speech language pathologist.	4.894 (0.315)
Question 7 - It was helpful to be seen by the nutritionist.	4.842 (0.501)
Question 8 - It was helpful to be seen by the pharmacist.	4.789 (0.535)

Primary outcome: Change in Patient Centered Outcome Questionnaire

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	EMPOWER PD Clinic Participation n = 19
Pain - Importance	34.47 (9.22)
Fatigue - Importance	50.26 (8.25)
Emotional Distress - Importance Emotional Distress - Importance	33.16 (8.21)
Interference with ADLs - Importance	41.48 (8.17)
Tremor - Importance	36.58 (7.99)
Stiffness - Importance	56.05 (8.72)
Slowness - Importance	45.53 (8.39)
Walking Problems - Importance	51.32 (9.23)

Primary outcome: Parkinson's Disease Knowledge Questionnaire

Time frame: Baseline and End of Study - 2 months. Mean (Standard Deviation). Unit: percentage of correct answers

Measure	EMPOWER PD Clinic Participation n = 18
PDKQ Pre-Assess	66.03 (10.23)
PDKQ Post-Assess	75.21 (12.32)

EMPOWER PD Clinic Participation: p = 0.015, t-test, 2 sided

Population analysed: One participant was dropped from the analysis due to cognitive impairment and difficulty completing the questionnaire

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EMPOWER PD Clinic Participation	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine M Clarkin, PhD principal investigator

University of Rhode Island

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Interdisciplinary Clinic in people with Parkinson Disease, run by University of Rhode Island at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and Accessibility (time frame: Baseline and End of Study - 2 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05640167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.