Trial Outcomes & Findings for The Utility of Telemedicine in the Management of Migraine (NCT NCT01706003)

Last Updated: 2019-10-25

Results Overview

Percentage of completed scheduled study visits for each group.

Recruitment status

COMPLETED

Target enrollment

45 participants

Primary outcome timeframe

One Year

Results posted on

2019-10-25

Participant milestones
Measure	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	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
Overall Study STARTED	23	22
Overall Study COMPLETED	12	18
Overall Study NOT COMPLETED	11	4

Reasons for withdrawal
Measure	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	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
Overall Study Withdrawal by Subject	2	0
Overall Study Not scheduled	3	0
Overall Study Lost to Follow-up	6	4

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	In-Office Group n=23 Participants 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	Telemedicine Group n=22 Participants People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=23 Participants	22 Participants n=22 Participants	45 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=45 Participants
Sex: Female, Male Female	21 Participants n=23 Participants	22 Participants n=22 Participants	43 Participants n=45 Participants
Sex: Female, Male Male	2 Participants n=23 Participants	0 Participants n=22 Participants	2 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	23 participants n=23 Participants	22 participants n=22 Participants	45 participants n=45 Participants
Migraine Disability Assessment Score (MIDAS)	40.5 units on a scale n=23 Participants	65 units on a scale n=22 Participants	47.9 units on a scale n=45 Participants

Timeframe: One Year

Percentage of completed scheduled study visits for each group.

Outcome measures
Measure	In-Office Group n=12 Participants 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	Telemedicine Group n=18 Participants People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches
Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice	87 percentage of scheduled appointments	92.7 percentage of scheduled appointments

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	In-Office Group n=23 participants at risk 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	Telemedicine Group n=22 participants at risk People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches
Nervous system disorders Hospital admission	0.00% 0/23 • 1 year	13.6% 3/22 • Number of events 5 • 1 year

Adverse event data not reported

UT Southwestern Medical Center

Phone: 2146483517