NCT01706003

Brief Summary

Patients will be randomly assigned to receive their follow-up care via telemedicine or in-office visits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 25, 2019

Completed
Last Updated

October 25, 2019

Status Verified

September 1, 2019

Enrollment Period

6 years

First QC Date

October 10, 2012

Results QC Date

June 11, 2019

Last Update Submit

September 29, 2019

Conditions

Keywords

MigraineHeadachesTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice

    Percentage of completed scheduled study visits for each group.

    One Year

Study Arms (2)

Telemedicine Group

People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches

In-Office Group

People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients must be diagnosed with Migraine Headaches

You may qualify if:

  • Diagnosis of migraine with or without aura, menstrual migraine, hemiplegic migraine
  • Able to provide informed consent
  • Able, in the opinion of the investigator, to reliably perform all aspects of the study
  • Ownership of or access to a computer and high speed internet
  • Age less than 18 years
  • Headache type is not migraine
  • No ownership or access to a computer or high speed internet
  • Unfamiliar with basic computer operations or uncomfortable using a computer
  • Unwilling to participate
  • Unable to read English (because of assessment tools)
  • History of another medical, psychiatric, social or behavioral problem that, in the opinion of the investigator, makes it unlikely that they will be able to complete the study activities. Questions regarding mood and anxiety are asked of all patients as part of their initial evaluation for headache.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universit of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • Friedman DI, Rajan B, Seidmann A. A randomized trial of telemedicine for migraine management. Cephalalgia. 2019 Oct;39(12):1577-1585. doi: 10.1177/0333102419868250. Epub 2019 Aug 26.

MeSH Terms

Conditions

Migraine DisordersHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Deborah I. Friedman, MD, MPH, Professor of Neurology and Neurotherapeutics and Ophthalmology
Organization
UT Southwestern Medical Center

Study Officials

  • Deborah Friedman, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator, MD, Neurology and Neurotheraputics

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 15, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 25, 2019

Results First Posted

October 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations