Parkinson PlusWECARE APDNCT06836921
WECARE APD: Assessing a Single Multidisciplinary Team Visit for Atypical Parkinsonian Disorders
A study testing MDC visit in people with Parkinson Plus, run by Western University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Plus
- What is being tested?
- MDC visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Parkinson Plus
- Being tested
- Standard of Care (Investigator Choice), MDC visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (Investigator Choice)Other
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.
MDC visitOther
The multidisciplinary clinic visit will use a shared appointment model and will include a specialized team comprising movement disorder neurologist, a palliative and critical care neurologist, a cognitive neurologist, a specialist nurse, a physiotherapist (PT), an occupational therapist (OT), a speech-language pathologist, and a social worker. Care will be delivered in an outpatient setting at a University Hospital. Prior to the initial visit, patients with APS and their care partners will receive a pre-visit questionnaire to identify their top three care priorities.
During the visit, the multidisciplinary team will convene with the patient and their care partner in a single appointment room. The session will begin by addressing each of the priority issues identified by the patient and care partner. The team will collaboratively discuss management strategies, focusing on self-management, and will provide real-time guidance and recommendations. As indicated, hands-on PT and OT evaluatio
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary clinic visit arm | Experimental | 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 |
| Waitlist arm | Other | 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. Receives: Other: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Participants Willing to be Randomized
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
Measured: From screening to enrollment , 12 months after study start
Percentage of Participants Completing Outcome Assessment
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
Measured: At 6 months after randomization
Satisfaction survey (Quantitative)
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
Measured: After 6 months of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Mar 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson PlusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepa Dash, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836921
- Sponsor's protocol ID
- 124694
- Acronym
- WECARE APD
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WECARE APD: Randomized Trial to Evaluate the Impact of a Single Multidisciplinary Team Visit for Atypical Parkinsonian Disorders: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06836921
- Acronym / sponsor ID
- WECARE APD / 124694
- Conditions
- Parkinson Plus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary clinic visit arm | Experimental | –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 |
| Waitlist arm | Other | 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Waitlist arm |
| MDC visitThe multidisciplinary clinic visit will use a shared appointment model and will include a specialized team comprising movement disorder neurologist, a palliative and critical care neurologist, a cognitive neurologist, a specialist nurse, a physiotherapist (PT), an occupational therapist (OT), a speech-language pathologist, and a social worker. Care will be delivered in an outpatient setting at a University Hospital. Prior to the initial visit, patients with APS and their care partners will receive a pre-visit questionnaire to identify their top three care priorities. During the visit, the multidisciplinary team will convene with the patient and their care partner in a single appointment room. The session will begin by addressing each of the priority issues identified by the patient and care partner. The team will collaboratively discuss management strategies, focusing on self-management, and will provide real-time guidance and recommendations. As indicated, hands-on PT and OT evaluatio | Other | – |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing MDC visit in people with Parkinson Plus, run by Western University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deepa Dash, MD, DM (5196633187, deepa.dash@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eligible Participants Willing to be Randomized (time frame: From screening to enrollment , 12 months after study start). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.