Clinical trial NCT02473692: Facilitating Migraine Medication Adherence and Optimizing Medication Use
Official title: Examining Feasibility and Effectiveness of an Internet-based Intervention for Facilitating Migraine Medication Adherence and Optimizing Medication Use
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Headache
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Post-intervention, at the end of the 1 week study period
Secondary outcomes:
measure: 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.
timeFrame: Post-intervention, at the end of the 1 week study period
Other outcomes:
Locations:
Study officials:
affiliation: WakeForest School of Medicine
name: Donald B Penzien, PhD
role: PRINCIPAL_INVESTIGATOR
References: