Tardive DyskinesiaNCT01467089
The Assessment of Movement Disorders Utilizing Live Two-Way Video
An observational study of Tardive Dyskinesia, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) examinations conducted via live two-way video versus live examinations completed in-person Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tardive Dyskinesia
- What is being tested?
- Two way video assessment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2016
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 patients with schizophrenia will be recruited via in- and outpatient psychiatry service of The Zucker Hillside Hospital.
Who may be able to join
- Inpatients and outpatients aged 18-75 years old who have been taking antipsychotics for longer than 6 months in their life time, and
- That have been compliant for the past week.
Who cannot join
- Patients who have medical conditions which make it difficult to perform a physical examination.
- Patients who are clinically too ill to consent and/or unable to cooperate with the examination procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
About this study
The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) examinations conducted via live two-way video versus live examinations completed in-person
Read the detailed description
Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) are one of the most frequent and troublesome adverse events when taking antipsychotic agents. The investigators aim in this study to determine if the investigators can conduct examinations for EPS and TD remotely using live two-way video. It is potentially beneficial for patients, especially those who are located far away from psychiatrists if they could be seen by trained clinicians and assessed for EPS and TD via two-way video in the future. Participants will be asked to have a medical assessment which consists of simple questions and some examination of their movements via two-way video and in person. The investigators will compare the results of video examinations with the results of live examinations.
- Conditions
- Tardive Dyskinesia
- Being tested
- Two way video assessment
- Keywords
- Schizophrenia, Extrapyramidal symptoms, Tardive dyskinesia, Two Way Video Assessment
- Medical subject headings
- Tardive Dyskinesia, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two way video assessmentOther
Participants will be assessed extrapyramidal symptoms and tardive dyskinesia
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia | Inclusion Criteria: Inpatients and outpatients aged 18-75 years old who have been taking antipsychotics for longer than 6 months in their life time, and that have been compliant for the past week. Patients will be referred by their treating doctors if they have some evidence of movement disorder based on the physician's clinical judgment. We will also include 25% of the sample without any evidence of movement disorder.
Exclusion Criteria: Patients who have medical conditions which make it difficult to perform a physical examination. Patients who are clinically too ill to consent and/or unable to cooperate with the examination procedures. Receives: Other: Two way video assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video
Measured: Baseline
Modified Simpson Angus Scale (mSAS) short version when done in-person versus via two-way video
Measured: Baseline
Secondary outcomes (1)
the correlation between the short version and full version of the Modified Simpson Angus Scale (mSAS)
total score of short version-Modified Simpson Angus Scale vs. total score of full version-Modified Simpson Angus Scale
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep kapoor, Northwell Health
- Investigators
- Sandeep Kapoor, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467089
- Sponsor's protocol ID
- 11-243B
- Status last verified
- Sep 2016
- First submitted
- 31 Oct 2011
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Movement Disorders Utilizing Live Two-Way Video
- ClinicalTrials.gov ID
- NCT01467089
- Acronym / sponsor ID
- 11-243B
- Conditions
- Tardive Dyskinesia
- Keywords
- Schizophrenia, Extrapyramidal symptoms, Tardive dyskinesia, Two Way Video Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Nov 2011 (estimated)
- 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.
The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) examinations conducted via live two-way video versus live examinations completed in-person
Detailed description
Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) are one of the most frequent and troublesome adverse events when taking antipsychotic agents. The investigators aim in this study to determine if the investigators can conduct examinations for EPS and TD remotely using live two-way video. It is potentially beneficial for patients, especially those who are located far away from psychiatrists if they could be seen by trained clinicians and assessed for EPS and TD via two-way video in the future. Participants will be asked to have a medical assessment which consists of simple questions and some examination of their movements via two-way video and in person. The investigators will compare the results of video examinations with the results of live examinations.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | – | Other: Two way video assessmentInclusion Criteria: Inpatients and outpatients aged 18-75 years old who have been taking antipsychotics for longer than 6 months in their life time, and that have been compliant for the past week. Patients will be referred by their treating doctors if they have some evidence of movement disorder based on the physician's clinical judgment. We will also include 25% of the sample without any evidence of movement disorder. Exclusion Criteria: Patients who have medical conditions which make it difficult to perform a physical examination. Patients who are clinically too ill to consent and/or unable to cooperate with the examination procedures. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients with schizophrenia will be recruited via in- and outpatient psychiatry service of The Zucker Hillside Hospital.
Key inclusion criteria (2 listed)
- Inpatients and outpatients aged 18-75 years old who have been taking antipsychotics for longer than 6 months in their life time, and
- That have been compliant for the past week.
Key exclusion criteria (2 listed)
- Patients who have medical conditions which make it difficult to perform a physical examination.
- Patients who are clinically too ill to consent and/or unable to cooperate with the examination procedures.
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 |
|---|---|---|
| Two way video assessmentParticipants will be assessed extrapyramidal symptoms and tardive dyskinesia | Other | schizophrenia |
Primary outcome
Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video
Time frame: Baseline
Modified Simpson Angus Scale (mSAS) short version when done in-person versus via two-way video
Time frame: Baseline
1 secondary outcome
the correlation between the short version and full version of the Modified Simpson Angus Scale (mSAS)
Time frame: Baseline
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 21 Sep 2016.
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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.
Sandeep Kapoor, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tardive Dyskinesia, run by Northwell Health 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 2 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 21 Sep 2016. 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?
Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video (time frame: Baseline). The study lists 2 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 21 Sep 2016.