Drug-Induced Movement DisorderNCT06060444
Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
A study testing Telemedicine Consult and In-person Consult in people with Drug-Induced Movement Disorder, run by University of Vermont at 1 site in United States.
Trial summary
In this pilot study, the investigators will evaluate care delivery via telemedicine to individuals with drug-induced movement disorders (DIMDs). DIMDs can be disabling, and prevention is important; but these disorders are often under-reported, under-recognized and poorly managed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-Induced Movement Disorder
- What is being tested?
- Telemedicine Consult and In-person Consult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Willing and able to provide consent
- Willing to have their Mental Health Clinician (MHC) share sensitive clinical information with the Neurology team
- Able to travel to Neurology clinic
- Have connectivity to Zoom using wi-fi or cellular data, either at home or a comfortable and private setting (such as MHC office)
Who cannot join
- Currently hospitalized
- Neurologist determines patient requires care outside of the scope of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
In this pilot study, the investigators will evaluate care delivery via telemedicine to individuals with drug-induced movement disorders (DIMDs). DIMDs can be disabling, and prevention is important; but these disorders are often under-reported, under-recognized and poorly managed. Interprofessional telemedicine for movement disorders is feasible and may provide similar care as in-person visits; however, the majority of studies to date have shown benefit in Parkinson's disease and further validation in other movement disorders is necessary.
In this randomized controlled trial the aim is to study the acceptability, feasibility, and patient and clinician outcomes when a neurological consultation is provided for patients with DIMDs either in-person or through telemedicine. The investigators will apply the evaluation framework RE-AIM (Reach and Effectiveness, Adoption, Implementation, and Maintenance) to comprehensively assess the factors that may impact study success and program implementation. Mixed methods will be implemented to gather outcome data from mental health clinicians that refer patients and the patient participants.
- Conditions
- Drug-Induced Movement Disorder
- Being tested
- Telemedicine Consult, In-person Consult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine ConsultOther
Neurological consultation completed remotely
In-person ConsultOther
Neurological consultation completed in-person
| Study group | Role | What they receive |
|---|---|---|
| In-Person | Other | Control group Receives: Other: In-person Consult |
| Telemedicine | Experimental | Not described Receives: Other: Telemedicine Consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8)
How satisfied are patients with the program
Measured: 12 months
Secondary outcomes (4)
Effectiveness; PROMIS 29+2 V2.1
What are the impacts on patient health status
Measured: 12 months
Effectiveness; referral forms and visit notes
Was there concordance in diagnosis between the MHC and movement disorder specialist
Measured: 12 months
Effectiveness; visit notes
Was there an impact on care plan
Measured: 12 months
Effectiveness; MHC survey and Qualitative Interviews
Were the MHCs Satisfied with the program
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start26 Apr 2022
- Primary completion20 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Induced Movement DisorderStudies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Neurocrine Biosciences
- Responsible party
- Principal investigator, Emily Houston, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060444
- Sponsor's protocol ID
- STUDY00001579
- Status last verified
- Nov 2024
- First submitted
- 10 Jun 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there is no plan to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
- ClinicalTrials.gov ID
- NCT06060444
- Acronym / sponsor ID
- STUDY00001579
- Conditions
- Drug-Induced Movement Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Neurocrine Biosciences
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 29 Sep 2023 (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.
In this pilot study, the investigators will evaluate care delivery via telemedicine to individuals with drug-induced movement disorders (DIMDs). DIMDs can be disabling, and prevention is important; but these disorders are often under-reported, under-recognized and poorly managed. Interprofessional telemedicine for movement disorders is feasible and may provide similar care as in-person visits; however, the majority of studies to date have shown benefit in Parkinson's disease and further validation in other movement disorders is necessary.
In this randomized controlled trial the aim is to study the acceptability, feasibility, and patient and clinician outcomes when a neurological consultation is provided for patients with DIMDs either in-person or through telemedicine. The investigators will apply the evaluation framework RE-AIM (Reach and Effectiveness, Adoption, Implementation, and Maintenance) to comprehensively assess the factors that may impact study success and program implementation. Mixed methods will be implemented to gather outcome data from mental health clinicians that refer patients and the patient participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person | Other | Other: In-person ConsultControl group |
| Telemedicine | Experimental | Other: Telemedicine Consult |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Willing and able to provide consent
- Willing to have their Mental Health Clinician (MHC) share sensitive clinical information with the Neurology team
- Able to travel to Neurology clinic
- Have connectivity to Zoom using wi-fi or cellular data, either at home or a comfortable and private setting (such as MHC office)
Key exclusion criteria (2 listed)
- Currently hospitalized
- Neurologist determines patient requires care outside of the scope of the study
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 |
|---|---|---|
| Telemedicine ConsultNeurological consultation completed remotely | Other | Telemedicine |
| In-person ConsultNeurological consultation completed in-person | Other | In-Person |
Primary outcome
Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: 12 months
How satisfied are patients with the program
4 secondary outcomes
Effectiveness; PROMIS 29+2 V2.1
Time frame: 12 months
Effectiveness; referral forms and visit notes
Time frame: 12 months
Effectiveness; visit notes
Time frame: 12 months
Effectiveness; MHC survey and Qualitative Interviews
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No. Currently there is no plan to share individual participant data (IPD) with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Consult and In-person Consult in people with Drug-Induced Movement Disorder, run by University of Vermont 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 5 inclusion and 2 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 5 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8) (time frame: 12 months). 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 5 Nov 2024.