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

NCT03969537 | Completed

• 1 other identifier: 190232
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Dystonia; Telemedicine

Keywords

Cervical Dystonia; Telemedicine; Telehealth

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction with Telehealth

  This questionnaire measures patient satisfaction with the telehealth visit scored 7 to 27

  4 months

Study Arms (1)

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

Interventions

Telemedicine follow-up visit OTHER

Study participants will experience two telemedicine (live audio/video) visits.

Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• The Allergan Foundation: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Charles, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: April 1, 2019
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)