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Facilitating Migraine Medication Adherence and Optimizing Medication Use

NCT ID: NCT02473692

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-30

Study Completion Date

2017-12-31

Brief Summary

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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).

Detailed Description

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Objective 1. To examine the feasibility and user usage patterns/demand of an online intervention designed to enhance adherence and optimize abortive medication-use for migraineurs.

Goal 1: To evaluate the practical utility of an Internet-based user environment to host an intervention designed to increase knowledge of and facilitate adherence and optimize abortive medication use.

Hypothesis 1A: That an Internet-based user environment can be appropriately suited to deliver an adherence intervention that, in turn, could be made widely accessible and readily employed.

Hypothesis 1B: That a high proportion of patients referred to the adherence facilitation Web site will actually visit and make use of the adherence intervention Web site.

Hypothesis 1C: That once the Web-based intervention is initiated, a low attrition rate will be observed and the majority of patients will complete the intervention.

Objective 2. To examine the efficacy of an online adherence facilitation and medication optimization intervention in increasing knowledge of optimal abortive medication-use.

Goal 2: To conduct a pilot trial examining the efficacy of an adherence and medication optimization intervention for improving knowledge and medication-use behavior in a wide range of migraine sufferers.

Hypothesis 2A: That patients who complete the Web-based intervention will demonstrate improved knowledge of optimal abortive medication strategies at post-treatment and this knowledge will be maintained at follow-up.

Hypothesis 2B: That patients who complete the Web-based intervention will report improved abortive medication use strategies at post-treatment and this behavior change will be maintained at follow-up.

Conditions

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Headache

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Online Migraine Treatment Optimization

Intervention Type 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)

Interventions

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Online Migraine Treatment Optimization

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adults \>= 18 year-old
2. Any self-reported headache disorder, from any etiology ( \> 5 attacks, lifetime)
3. Self-reported use of any headache abortive treatment:

* Over the counter (e.g., Ibuprofen, naproxen sodium, Excedrin, etc.)
* Prescription (Triptans, CGRP antagonist, Ibuprofen, etc.)

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald B Penzien, PhD

Role: PRINCIPAL_INVESTIGATOR

WakeForest School of Medicine

Other Identifiers

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MK-0974

Identifier Type: -

Identifier Source: org_study_id