NCT05640167

Brief 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. The primary objective is to assess feasibility and acceptability of the newly developed clinic intervention as well as individual perception of experience and barriers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

November 18, 2022

Results QC Date

July 15, 2024

Last Update Submit

July 15, 2025

Conditions

Keywords

Patient-centric careInterdisciplinary careParkinson Disease education

Outcome Measures

Primary Outcomes (5)

  • 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.

    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

Secondary Outcomes (4)

  • Change in Self-Efficacy for Exercise

    Baseline and End of Study - 2 Months

  • Change in Balance Confidence Measured With the Activities-specific Balance Confidence (ABC) Scale.

    Baseline and End of Study - 2 Months

  • Change in Quality of Life Measured With the Parkinson Disease Questionnaire-39 (PDQ-39)

    Baseline and End of Study - 2 Months

  • Change in the Parkinson's Fatigue Scale (PFS-16).

    Baseline and End of Study - 2 Months

Study Arms (1)

EMPOWER PD Clinic Participation

OTHER

All participants will be assigned to the same interdisciplinary clinic and educational intervention

Behavioral: Interdisciplinary Clinic

Interventions

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

EMPOWER PD Clinic Participation

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rhode Island - Physical Therapy Department

Kingston, Rhode Island, 02881, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Dr Christine Clarkin, Principal Investigator
Organization
University of Rhode Island

Study Officials

  • Christine M Clarkin, PhD

    University of Rhode Island

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 7, 2022

Study Start

March 31, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 1, 2025

Results First Posted

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations