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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Interdisciplinary Clinic

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: christine M clarkin, PhD, DPT; Phone Number: 401-874-2998; Email: chrisclarkin@uri.edu
• Study Contact Backup: Name: Leslie A Mahler, PhD, CCC-SLP; Phone Number: 401-874-2490; Email: lmahler@uri.edu

Study Locations

• United States
  • Rhode Island
    • Kingston, Rhode Island, United States, 02881
      • University of Rhode Island - Physical Therapy Department
      • Contact: christine M clarkin, PhD, DPT; Phone Number: 401-874-2998; Email: chrisclarkin@uri.edu
      • Contact: Leslie A Mahler, PhD, CCC-SLP; Phone Number: 401-874-2490; Email: lmahler@uri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EMPOWER PD Clinic Participation; All participants will be assigned to the same interdisciplinary clinic and educational intervention	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Semi-structured Interview	Acceptability, process, barriers, and perception of experience of clinic as measured by qualitative framework analysis of semi-structured interview	End of Study - 2 Months
Feasibility: Program Survey	A series of statements regarding acceptability, process, barriers, and perception of experience of clinic will b scored by participants on a scale of 1 (disagree) to 5 (agree) with a higher score on each statement indicating more positive outcome.	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.	End of Study - 2 Months
Change in Parkinson's Disease Knowledge Questionnaire	Knowledge regarding Parkinson's disease as measured by the Parkinson's Disease Knowledge Questionnaire. Participants indicate their knowledge of 26 items related to Parkinson's disease with a true or false response.	Post Education Seminar - 2 weeks
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 4 ("strongly agree").	End of Study - 2 Months

Secondary Outcome Measures

Outcome Measure	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	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 11-point scale 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.	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.	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.	End of Study - 2 Months

Collaborators and Investigators

• Sponsor: University of Rhode Island
• Collaborators: Brown University
• Investigators: Principal Investigator: Christine M Clarkin, PhD, University of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Patient-centric care; Interdisciplinary care; Parkinson Disease education
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 1929810-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No