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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interdisciplinary Clinic
Sponsored by
University of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson Disease focused on measuring Patient-centric care, Interdisciplinary care, Parkinson Disease education

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Rhode Island - Physical Therapy DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EMPOWER PD Clinic Participation

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility: Semi-structured Interview
Acceptability, process, barriers, and perception of experience of clinic as measured by qualitative framework analysis of semi-structured interview
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.
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.
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.
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").

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
November 18, 2022
Last Updated
September 26, 2023
Sponsor
University of Rhode Island
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT05640167
Brief Title
EMPOWER PD - Feasibility of an Interdisciplinary Clinic for People With Parkinson's Disease
Official Title
EMPOWER PD - Feasibility of an Interdisciplinary Clinic for People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rhode Island
Collaborators
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Patient-centric care, Interdisciplinary care, Parkinson Disease education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMPOWER PD Clinic Participation
Arm Type
Other
Arm Description
All participants will be assigned to the same interdisciplinary clinic and educational intervention
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary Clinic
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility: Semi-structured Interview
Description
Acceptability, process, barriers, and perception of experience of clinic as measured by qualitative framework analysis of semi-structured interview
Time Frame
End of Study - 2 Months
Title
Feasibility: Program Survey
Description
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.
Time Frame
End of Study - 2 Months
Title
Change in Patient Centered Outcome Questionnaire
Description
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.
Time Frame
End of Study - 2 Months
Title
Change in Parkinson's Disease Knowledge Questionnaire
Description
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.
Time Frame
Post Education Seminar - 2 weeks
Title
Change in Health Education Impact Questionnaire
Description
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").
Time Frame
End of Study - 2 Months
Secondary Outcome Measure Information:
Title
Change in Self-Efficacy for Exercise
Description
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
Time Frame
End of Study - 2 Months
Title
Change in balance confidence measured with the Activities-specific Balance Confidence (ABC) Scale.
Description
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.
Time Frame
End of Study - 2 Months
Title
Change in quality of life measured with the Parkinson Disease Questionnaire-39 (PDQ-39)
Description
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.
Time Frame
End of Study - 2 Months
Title
Change in the Parkinson's Fatigue Scale (PFS-16).
Description
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.
Time Frame
End of Study - 2 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine M Clarkin, PhD, DPT
Phone
401-874-2998
Email
chrisclarkin@uri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie A Mahler, PhD, CCC-SLP
Phone
401-874-2490
Email
lmahler@uri.edu
Facility Information:
Facility Name
University of Rhode Island - Physical Therapy Department
City
Kingston
State/Province
Rhode Island
ZIP/Postal Code
02881
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
christine M clarkin, PhD, DPT
Phone
401-874-2998
Email
chrisclarkin@uri.edu
First Name & Middle Initial & Last Name & Degree
Leslie A Mahler, PhD, CCC-SLP
Phone
401-874-2490
Email
lmahler@uri.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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