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

NCT ID: NCT05640167

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2023-06-30

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.

Detailed Description

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

EMPOWER PD Clinic Participation

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

Group Type: OTHER

Interdisciplinary Clinic

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

University of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine M Clarkin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rhode Island

Locations

University of Rhode Island - Physical Therapy Department

Kingston, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan Original

View Document

Other Identifiers

1929810-1

Identifier Type: -

Identifier Source: org_study_id