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Telemedicine Follow-up for Patients With Cervical Dystonia Treated With Neurotoxin Injections
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Cervical Dystonia Telemedicine | Other: Telemedicine follow-up visit |
| Study Type : | Observational |
| Actual Enrollment : | 27 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Telemedicine Follow-up for Patients With Cervical Dystonia Treated With Neurotoxin Injections |
| Actual Study Start Date : | April 1, 2019 |
| Actual Primary Completion Date : | June 4, 2020 |
| Actual Study Completion Date : | June 4, 2020 |
| 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.
|
- Patient Satisfaction with Telehealth [ Time Frame: 4 months ]This questionnaire measures patient satisfaction with the telehealth visit scored 7 to 27
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | David Charles, MD | Vanderbilt University Medical Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 29, 2019 | ||||
| First Posted Date | May 31, 2019 | ||||
| Last Update Posted Date | November 2, 2020 | ||||
| Actual Study Start Date | April 1, 2019 | ||||
| Actual Primary Completion Date | June 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Patient Satisfaction with Telehealth [ Time Frame: 4 months ] This questionnaire measures patient satisfaction with the telehealth visit scored 7 to 27
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Telemedicine Follow-up for Patients With Cervical Dystonia Treated With Neurotoxin Injections | ||||
| Official Title | Telemedicine Follow-up for Patients With Cervical Dystonia Treated With Neurotoxin Injections | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
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| Intervention | Other: Telemedicine follow-up visit
Study participants will experience two telemedicine (live audio/video) visits.
|
||||
| Study Groups/Cohorts | 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.
Intervention: Other: Telemedicine follow-up visit
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
27 | ||||
| Original Estimated Enrollment |
30 | ||||
| Actual Study Completion Date | June 4, 2020 | ||||
| Actual Primary Completion Date | June 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03969537 | ||||
| Other Study ID Numbers | 190232 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | David Charles, Vanderbilt University Medical Center | ||||
| Study Sponsor | Vanderbilt University Medical Center | ||||
| Collaborators | Allergan Foundation | ||||
| Investigators |
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| PRS Account | Vanderbilt University Medical Center | ||||
| Verification Date | October 2020 | ||||
