The Assessment of Movement Disorders Utilizing Live Two-Way Video

September 19, 2016 updated by: Sandeep kapoor, Northwell Health
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

37

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • Glen Oaks, New York, United States, 11004
        • The Zucker Hillside Hospital

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

40 patients with schizophrenia will be recruited via in- and outpatient psychiatry service of The Zucker Hillside Hospital.

Description

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.

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Two way video assessment
Participants will be assessed extrapyramidal symptoms and tardive dyskinesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video
Time Frame: Baseline
Baseline
Modified Simpson Angus Scale (mSAS) short version when done in-person versus via two-way video
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the correlation between the short version and full version of the Modified Simpson Angus Scale (mSAS)
Time Frame: Baseline
total score of short version-Modified Simpson Angus Scale vs. total score of full version-Modified Simpson Angus Scale
Baseline

Collaborators and Investigators

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

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Sandeep Kapoor, MD, Northwell Health

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

November 1, 2011

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (ESTIMATE)

November 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-243B

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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