Migraine
Conditions
Brief summary
This project aims to develop the protocol and obtain feasibility and acceptability information for Telehealth Behavioral Migraine Management in a single-arm pre-post pilot study. The investigator and study team aim to recruit 20 people with migraine from the Montefiore Headache Center in the Bronx New York. Participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.
Interventions
BEHAVIORALTelehealth Behavioral Migraine Management
1\) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
BEHAVIORALEducation Modules
Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete.
Sponsors
Albert Einstein College of Medicine
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Physician diagnosis of migraine * Current self-reported symptoms meeting the International Classification for Headache Disorders -- 3 criteria for migraine * Self-reported between 4 and 20 headache days/month * Aged 18-65 * Can read English * Capacity to consent
Exclusion criteria
* Psychiatric illness that would interfere with study participation * Meeting criteria for probable medication overuse headache
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of TeleBMM | Week 0 through Week 12 | Feasibility of the study will be based on patient adherence to the protocol. The number of treatment components participants complete (out of 20) will be tabulated. It is hypothesized that at least half of the participants will attend all four study sessions and complete all three self-guided modules. Dropouts will be included in the analysis. Results will be summarized using basic descriptive statistics. |
| Acceptability - Patient-Rated Satisfaction | Post-treatment survey at Week 12 | Patient-rated satisfaction (acceptability) with the program will be based on responses to the overall satisfaction question on a satisfaction survey. Participants are asked to rate overall satisfaction with the Telehealth Behavioral Management Program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied"). Acceptability was to have been evaluated both on completers and assuming that individuals who dropped out were not satisfied (i.e., "Not at all satisfied"). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (Migraine Specific) | Change from Pre-treatment (Week 0) to Post-treatment (Week 12) | Change in Migraine-related disability over the prior 4 week period was assessed based on Version 2.1 of the Migraine Specific Quality of Life Questionnaire (MSQ). The MSQ is a 14-item survey assessing quality of life in people with migraine. Responses from the 14 Items (which are reverse-coded) encompassing three domains (Role Restriction - 7 items; Role Prevention - 4 items; and Emotional Function - 3 items) were rated on a 6-point scale ranging from 1 ("None of the time") to 6 ("All of the time"). Raw scores were summed and linearly converted to a 0-100 scale wherein higher scores are associated with a better quality of life. For purposes of this study, change from baseline was assessed such that higher scores reflect an increased quality of life from baseline and negative scores reflect a decreased quality of life from baseline. Scores are summarized by study arm using descriptive statistics. |
| Change in Headache Frequency | Change from Week 0 to Week 12 | Participants were asked to complete a daily headache diary, on which each 7 day week they denoted whether they have had a headache attack. Slope change from Week 0 to Week 12 is reported as a proportion of headache days/month (ranging from 0-1) and is summarized by study arm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth K Seng, Ph.D.
Yeshiva University/Albert Einstein College of Medicine
Participant flow
Pre-assignment details
Participants were permitted to select which arm they wished to enroll in during this study, as this was a pilot for feasibility. No participants chose the third arm.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 40.6 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Monthly Proportion of Headache Days | 0.50 Proportion of headache days/month STANDARD_DEVIATION 0.04 |
| Quality of Life (Migraine Specific) | 58.6 score on a scale STANDARD_DEVIATION 22.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 6 |
| other Total, other adverse events | 0 / 14 | 0 / 6 |
| serious Total, serious adverse events | 0 / 14 | 0 / 6 |
Outcome results
None listed