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

Telemedicine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969537
• Other study ID #: 190232
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: June 4, 2020

Study information

• Verified date: October 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 4, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Telemedicine
• Torticollis

Intervention

Other:
• Telemedicine follow-up visit
Study participants will experience two telemedicine (live audio/video) visits.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Allergan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction with Telehealth	This questionnaire measures patient satisfaction with the telehealth visit scored 7 to 27	4 months