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Clinical Trials/NCT05640167
NCT05640167CompletedNot Applicable

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

University of Rhode Island2 sites in 1 country19 target enrollmentStarted: March 31, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
2
Primary Endpoint
Feasibility and Accessibility

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
40 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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.

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.

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.

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").

Secondary Outcomes

  • Change in Quality of Life Measured With the Parkinson Disease Questionnaire-39 (PDQ-39)(Baseline and End of Study - 2 Months)
  • 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 the Parkinson's Fatigue Scale (PFS-16).(Baseline and End of Study - 2 Months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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