Telemedicine Follow-up for Patients With Cervical Dystonia Treated With Neurotoxin Injections

October 30, 2020 updated by: David Charles, Vanderbilt University Medical Center

Many cervical dystonia (CD) patients are limited in their ability to travel to the clinic for follow-up in between injection visits.

A telemedicine visit at the time of peak effectiveness of neurotoxin treatment may be valuable in informing the neurologist's choice of muscle selection and/or dose for the next injection visit. The primary objective of this study is to investigate both patient and physician satisfaction with the use of our telemedicine tool for this type of follow-up. After assessment of the subject, the neurologist will decide whether or not the telemedicine visit was informative to the upcoming injection visit. Subjects will answer questions at the end of the visit regarding their satisfaction with the follow-up and overall telemedicine communication. The principle investigator will complete a similar survey with additional questions about information gathered from the visit to assess the primary objective.

A secure video communications platform will be used for the visit, which will occur 2-4 weeks after the patient's last neurotoxin injection (around the time of peak effectiveness). The investigating neurologist will remotely assess the patient and make notes for the next injection visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

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
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients selected to participate in the study are cervical dystonia (CD) patients who receive treatment at Vanderbilt University Medical Center, where the study takes place.

Description

Inclusion Criteria:

  • Male or female subjects of any race, aged 18 and above
  • Diagnosed with cervical dystonia and being treated with neurotoxin injections at Vanderbilt University Medical Center
  • The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.
  • Email and internet access
  • Personal computing device with audio/video capability

Exclusion Criteria:

  • Subjects for whom participation in the study may cause medical harm

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
Telemedicine
The patients selected to participate in the study are cervical dystonia (CD) patients who receive treatment at Vanderbilt University Medical Center, where the study takes place.
Other: Telemedicine follow-up visit
Study participants will experience two telemedicine (live audio/video) visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction with Telehealth
Time Frame: 4 months
This questionnaire measures patient satisfaction with the telehealth visit scored 7 to 27
4 months

Collaborators and Investigators

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

Sponsor

Vanderbilt University Medical Center

Collaborators

Allergan Foundation

Investigators

  • Principal Investigator: David Charles, MD, Vanderbilt University Medical Center

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 (Actual)

April 1, 2019

Primary Completion (Actual)

June 4, 2020

Study Completion (Actual)

June 4, 2020

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 30, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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