Parkinson DiseaseNCT04555720
The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
A study testing Interdisciplinary Visit in people with Parkinson Disease, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine if an interdisciplinary clinic can help people with Parkinson's disease care for themselves, improve their ability to follow recommended treatments, and have fewer problems like falls or visits to the emergency room. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Interdisciplinary Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's Disease over the age of 30,
- Caregiver willing to also participate.
- Must be able to provide consent.
Who cannot join
- -Atypical Parkinsonism
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if an interdisciplinary clinic can help people with Parkinson's disease care for themselves, improve their ability to follow recommended treatments, and have fewer problems like falls or visits to the emergency room.
Participants will be randomly assigned to receive either care from the interdisciplinary clinic or standard neurological specialist care.
This study involves questionnaires both before and 3 months after participation in a one time interdisciplinary care clinic or standard care depending on which type of care the participant is randomized to. Participants will be in the study for up to 6 months. The study will end upon completion of questionnaires about 3 months after treatment with the interdisciplinary care clinic or standard care.
- Conditions
- Parkinson Disease
- Being tested
- Interdisciplinary Visit
- Keywords
- interdisciplinary care, patient engagement, preventative care
- Medical subject headings
- Parkinson Disease, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary VisitBehavioural
If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary Care | Experimental | If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Receives: Behavioral: Interdisciplinary Visit |
| Standard of Care | No intervention | If assigned to standard of care, group participants will have a normally scheduled visit with neurologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Score on Self-efficacy Scale
Title of scale: Self-efficacy Scale for Chronic Diseases. This is a validated scale. Minimum score is 6, Maximum score is 60. Higher score is a better outcome.
Measured: Baseline, 3 months after interdisciplinary or standard clinic visit
Secondary outcomes (7)
Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey.
Investigator developed patient engagement survey
Measured: Baseline, 3 months after interdisciplinary or standard care visit
Change in Caregiver Burden Score on Zarit Burden Interview Scale
Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome.
Measured: Baseline, 3 months after interdisciplinary or standard care visit
Number of Skilled Therapy Visits as Reported by Participant
Number of skilled therapy visits as reported by participant
Measured: Baseline, 3 months after interdisciplinary or standard care visit
Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review
Number of participants with a hospitalization as reported by participant and medical record review
Measured: Baseline, 3-6 months after interdisciplinary or standard care visit
Number of Participants With an ER Visit as Reported by Participant and Medical Record Review
Number of participants with an ER visit as reported by participant and medical record review
Measured: Baseline, 3-6 months after interdisciplinary or standard care visit
Number Participants With a Fall as Reported by Participant and Medical Record Review
Number participants with a fall as reported by Participant and Medical Record Review
Measured: Baseline, 3 months after interdisciplinary or standard care visit
Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review
Number of participants with a contraindicated medication combination as determined by medical record review
Measured: Baseline, 3-6 months after interdisciplinary or standard care visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start3 Feb 2021
- Primary completion28 Sep 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Mitchell, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555720
- Sponsor's protocol ID
- Pro00105281
- Status last verified
- Apr 2022
- First submitted
- 14 Sep 2020
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04555720
- Acronym / sponsor ID
- Pro00105281
- Conditions
- Parkinson Disease
- Keywords
- interdisciplinary care, patient engagement, preventative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if an interdisciplinary clinic can help people with Parkinson's disease care for themselves, improve their ability to follow recommended treatments, and have fewer problems like falls or visits to the emergency room.
Participants will be randomly assigned to receive either care from the interdisciplinary clinic or standard neurological specialist care.
This study involves questionnaires both before and 3 months after participation in a one time interdisciplinary care clinic or standard care depending on which type of care the participant is randomized to. Participants will be in the study for up to 6 months. The study will end upon completion of questionnaires about 3 months after treatment with the interdisciplinary care clinic or standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary Care | Experimental | Behavioral: Interdisciplinary VisitIf assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. |
| Standard of Care | No intervention | –If assigned to standard of care, group participants will have a normally scheduled visit with neurologist. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Parkinson's Disease over the age of 30,
- Caregiver willing to also participate.
- Must be able to provide consent.
Key exclusion criteria (1 listed)
- -Atypical Parkinsonism
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 |
|---|---|---|
| Interdisciplinary VisitIf assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. | Behavioural | Interdisciplinary Care |
Primary outcome
Change in Composite Score on Self-efficacy Scale
Time frame: Baseline, 3 months after interdisciplinary or standard clinic visit
Title of scale: Self-efficacy Scale for Chronic Diseases. This is a validated scale. Minimum score is 6, Maximum score is 60. Higher score is a better outcome.
7 secondary outcomes
Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey.
Time frame: Baseline, 3 months after interdisciplinary or standard care visit
Change in Caregiver Burden Score on Zarit Burden Interview Scale
Time frame: Baseline, 3 months after interdisciplinary or standard care visit
Number of Skilled Therapy Visits as Reported by Participant
Time frame: Baseline, 3 months after interdisciplinary or standard care visit
Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review
Time frame: Baseline, 3-6 months after interdisciplinary or standard care visit
Number of Participants With an ER Visit as Reported by Participant and Medical Record Review
Time frame: Baseline, 3-6 months after interdisciplinary or standard care visit
Number Participants With a Fall as Reported by Participant and Medical Record Review
Time frame: Baseline, 3 months after interdisciplinary or standard care visit
Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review
Time frame: Baseline, 3-6 months after interdisciplinary or standard care visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Kyle Mitchell, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary Visit in people with Parkinson Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Composite Score on Self-efficacy Scale (time frame: Baseline, 3 months after interdisciplinary or standard clinic visit). 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 13 Aug 2024.