WECARE APD: Assessing a Single Multidisciplinary Team Visit for Atypical Parkinsonian Disorders (WECARE APD)

February 15, 2025 updated by: Deepa Dash, Western University

WECARE APD: Randomized Trial to Evaluate the Impact of a Single Multidisciplinary Team Visit for Atypical Parkinsonian Disorders: a Feasibility Study

Atypical Parkinsonian disorders (APD) are a group of brain disorders that look like Parkinson's disease but progress faster and don't respond well to common treatments like levodopa. These conditions include Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS), and Multiple System Atrophy (MSA). Caring for APD patients is especially challenging because the symptoms worsen quickly and require multiple specialists, often leading to separate visits with different doctors and therapists. This not only increases the burden on patients and caregivers but also results in high medical costs. Despite the serious impact of APD, there is no proven care model that significantly improves the quality of life for patients and their caregivers.

To address this, the investigator team has created a novel type of clinic that brings together a team of specialists in a shared appointment to provide comprehensive care in one visit. This study aims to test whether an early visit with this team, in addition to regular medical care, can improve quality of life, help patients manage their symptoms better, and reduce the stress on caregivers. The investigators will conduct a six-month study with two groups: one will receive the multidisciplinary care visit right away, while the other will continue with regular care and receive the visit after six months. Patients and caregivers will fill out questionnaires about their well-being at the beginning, after one month, and after six months. The study will also measure how practical it is to run this type of clinic, making sure enough people participate, complete the required surveys, and stay in the study.

This will be the first study to test whether a team-based care model is practical and beneficial for APD patients and their caregivers. If successful, it could serve as a foundation for larger studies and potentially improve care for other complex neurological conditions in the future.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (Participants must meet all of the following conditions to be eligible for the study):

  • Participants must be older than 40 years.
  • The participant must meet the standard international consensus criteria for a clinically probable diagnosis of one of the following neurodegenerative conditions:Multiple System Atrophy (MSA);Progressive Supranuclear Palsy (PSP);Cortico-Basal Syndrome (CBS)

Exclusion Criteria (Participants will be excluded if they meet any of the following conditions):

  • Severe Physical or Cognitive Limitations:

    • Participants must be able to attend the clinic.
    • Individuals with severe physical disabilities or cognitive impairments that prevent clinic attendance will be excluded.

  • Life-Threatening Comorbidities:

    • Participants with severe, advanced medical conditions that significantly impact survival or functional ability will be excluded. These include, but are not limited to:End-stage renal disease (ESRD) requiring dialysis; End-stage congestive heart failure (CHF) with severe functional impairment; Advanced malignancy (such as metastatic cancer or terminal cancer with limited prognosis).
  • Living in long-term care, away from the care-partner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multidisciplinary clinic visit arm
The multidisciplinary clinic visit will follow a shared appointment model and involve a specialized team consisting of a movement disorder neurologist, a palliative and critical care neurologist, a cognitive neurologist, a specialist nurse, a physiotherapist, an occupational therapist, a speech-language pathologist, and a social worker. Care will be provided in an outpatient setting at a University Hospital. Before the initial visit, patients with APS and their care partners will complete a pre-visit questionnaire to identify their top three care priorities. During the visit, the multidisciplinary team will meet with the patient and their care partner in a single appointment room, beginning the session by addressing the identified priority issues. The team will collaboratively discuss management strategies, emphasizing self-management, and provide real-time guidance and recommendations. If needed, hands-on physiotherapy and occupational therapy evaluations will be conducted during the
Other: Waitlist arm
Participants in the control group will receive usual care, consisting of regular management by their neurologist, family physician, and other healthcare providers. This standard care may include referrals to community services, allied health professionals, and other support typically provided during the waitlist period for MDC visit.
Other: Standard of Care (Investigator Choice)
Participants in the control group will receive usual care, consisting of regular management by their neurologist, family physician, and other healthcare providers. This standard care may include referrals to community services, allied health professionals, and other support typically provided during the waitlist period for MDC visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eligible Participants Willing to be Randomized
Time Frame: From screening to enrollment , 12 months after study start

Definition: The proportion of eligible participants who consent to randomization in the study.

Measurement:

Total number of eligible participants approached for the study. Number of participants who provide informed consent and agree to be randomized.

Formula:

Percentage Willing=( Total Eligible Participants Approached Participants Consented and Randomized )×100
From screening to enrollment , 12 months after study start
Percentage of Participants Completing Outcome Assessment
Time Frame: At 6 months after randomization

Definition: The proportion of participants who successfully complete all required outcome assessments at designated time points.

Measurement:

Tracking the number of participants who complete each outcome assessment. Comparison of completion rates across different study arms.

Formula:

Completion Rate=(Participants Who Complete All Required Assessments Total Participants Enrolled)×100
At 6 months after randomization
Satisfaction survey (Quantitative)
Time Frame: After 6 months of randomization

Response Categories (5-point Likert scale):

Very satisfied Satisfied Neutral Unsatisfied Very unsatisfied

Analysis Approach:

Responses will be dichotomized into:

Satisfied: Very satisfied + Satisfied Not Satisfied: Neutral + Unsatisfied + Very unsatisfied The proportion of participants in each category will be calculated.

Formula:

Satisfaction Rate

=(Satisfied Responses Total Responses)×100
After 6 months of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124694

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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