Facilitating Migraine Medication Adherence and Optimizing Medication Use

NCT02473692 | Withdrawn

• 1 other identifier: MK-0974
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present research will pilot-test a new state-of-the-art Internet-based intervention targeting adherence facilitation and optimization of medication use, and will be evaluated to assess its utility in facilitating adherence and optimization of medication use for acute migraine pharmacotherapy. This is not an interventional study and will instead be an observational assessment of the feasibility of an online program (a proof-of-concept study). The two principal objectives of this study include: (a) examination of the feasibility and user usage patterns of an Internet-based intervention designed to potentially enhance adherence to medication use recommendations, and (b) determination of the efficacy of the Internet-based intervention in potentially increasing knowledge of abortive medication-use guidelines and in improving adherence to those guidelines. To meet the objectives of this study, a website has been specifically developed including a series of supplemental text-based headache materials and a series of videos based social learning theory and modeling principles (as opposed to the stereotypical 'talking-heads' mode of information delivery).

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• Feasibility assessed by the practical utility of an Internet-based user environment to host an intervention designed to increase knowledge of and facilitate adherence to abortive medication use guidelines.

  Feasibility will be demonstrated based on the number of participants who complete the online videos.

  Post-intervention, at the end of the 1 week study period

Secondary Outcomes (1)

• Attrition assessed by the rate of attrition from the study, determined based upon the number of enrolled participants who do not complete the online video portion.

  Post-intervention, at the end of the 1 week study period

Study Arms (1)

Online MigraineTreatment Optimization

After providing informed consent, participants will complete a series of questionnaires related to their headaches and medication beliefs. After completion, they will have full access to an informational website including access to text-based supplemental materials pertaining to headache and headache treatment, and a series of videos designed specifically for this trial. Participants will be asked to watch seven videos of approximately four-minute length each and to complete a post-assessment question following the completion of each of the first 6 videos. The total time required to complete all study activities will be approximately one hour.

Other: Online Migraine Treatment Optimization

Interventions

Online Migraine Treatment Optimization OTHER

The educational videos entail a young woman (i.e., an actress) describing her experiences in managing her headaches. The informational content of the videos is organized into 7 content areas that present a wealth of information in an entertaining way: 1. Introduction to the series 2. Getting to know migraine 3. Making the most of your medical care 4. Partnering with your doctor 5. Best use of migraine medication 6. Keeping tabs on your migraine 7. Take home message (summary)

Online MigraineTreatment Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll N = 300 participants. The proposed study is primarily powered to estimate the rate at which headache patients will likely seek out the Web site within a desired precision range (i.e., Hypothesis 1A). This sample size will allow the characterization of the various event rates within a precise range. For example, this sample size would allow a precision of +/- 5% around most event rates (i.e., use rates, attrition rates, etc.). Finally, even with a large attrition rate (i.e., 50%) the proposed sample size will allow the detection of even small changes (e.g., d = 0.20) in the adherence measures (assuming adequate reliability, and a modest correlation between measurement occasions).

You may qualify if:

• Adults \>= 18 year-old
• Any self-reported headache disorder, from any etiology ( \> 5 attacks, lifetime)
• Self-reported use of any headache abortive treatment:
• Over the counter (e.g., Ibuprofen, naproxen sodium, Excedrin, etc.)
• Prescription (Triptans, CGRP antagonist, Ibuprofen, etc.)

You may not qualify if:

• Inability to read and write English (the questionnaires are exclusively in English)
• Inability to accurately complete questionnaire or provide informed consent: (e.g., Florid psychosis, Current intoxication)
• No internet access

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald B Penzien, PhD

  WakeForest School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 16, 2015
• Study Start: June 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-08