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出境医 / 临床实验 / Telehealth Behavioral Migraine Management (TeleBMM)

Telehealth Behavioral Migraine Management (TeleBMM)

Study Description
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. I aim recruit 20 people with migraine from the Montefiore Headache Center in the Bronx NY. 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.

Condition or disease Intervention/treatment Phase
Migraine Behavioral: Telehealth Behavioral Migraine Management Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telehealth Behavioral Migraine Management
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : May 13, 2022
Estimated Study Completion Date : August 15, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Telehealth Behavioral Migraine Management
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
 Behavioral: Telehealth Behavioral Migraine Management
1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
Outcome Measures
Primary Outcome Measures :
  1. Feasibility of TeleBMM [ Time Frame: Week 0 through Week 12 ]
    Number of treatment components participants complete (out of 20)


Secondary Outcome Measures :
  1. Patient-rated satisfaction [ Time Frame: Post-treatment survey at Week 12 ]
    Patient-rated satisfaction (acceptability) with the program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied")

  2. Quality of Life (Migraine Specific) [ Time Frame: Change from Pre-treatment (Week 0) to Post-treatment (Week 12) ]
    Score on the MSQ v 2.1, a 14-item survey assessing quality of life in people with migraine.

  3. Headache frequency [ Time Frame: Slope change from Week 0 to Week 12 ]
    Participants complete a daily headache diary, on which each 7 day week they denote whether they have had a headache attack.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Elizabeth K Seng, Ph.D. 646-592-4368 Elizabeth.Seng@einstein.yu.edu

Locations
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United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Elizabeth K Seng, Ph.D.    646-592-4368    Elizabeth.Seng@einsteinmed.org   
Sponsors and Collaborators
Albert Einstein College of Medicine
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Elizabeth K Seng, Ph.D. Yeshiva University/Albert Einstein College of Medicine
Tracking Information
First Submitted Date  ICMJE June 8, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date June 1, 2021
Actual Study Start Date  ICMJE September 15, 2020
Estimated Primary Completion Date May 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2019) 		Feasibility of TeleBMM [ Time Frame: Week 0 through Week 12 ]
Number of treatment components participants complete (out of 20)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2019)
  • Patient-rated satisfaction [ Time Frame: Post-treatment survey at Week 12 ]
    Patient-rated satisfaction (acceptability) with the program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied")
  • Quality of Life (Migraine Specific) [ Time Frame: Change from Pre-treatment (Week 0) to Post-treatment (Week 12) ]
    Score on the MSQ v 2.1, a 14-item survey assessing quality of life in people with migraine.
  • Headache frequency [ Time Frame: Slope change from Week 0 to Week 12 ]
    Participants complete a daily headache diary, on which each 7 day week they denote whether they have had a headache attack.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telehealth Behavioral Migraine Management
Official Title  ICMJE Telehealth Behavioral Migraine Management
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. I aim recruit 20 people with migraine from the Montefiore Headache Center in the Bronx NY. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Behavioral: Telehealth Behavioral Migraine Management
1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
Study Arms  ICMJE Experimental: Telehealth Behavioral Migraine Management
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
Intervention: Behavioral: Telehealth Behavioral Migraine Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2022
Estimated Primary Completion Date May 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth K Seng, Ph.D. 646-592-4368 Elizabeth.Seng@einstein.yu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982316
Other Study ID Numbers  ICMJE 2019-10345
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE National Center for Advancing Translational Science (NCATS)
Investigators  ICMJE
Principal Investigator: Elizabeth K Seng, Ph.D. Yeshiva University/Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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