- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02473692
Facilitating Migraine Medication Adherence and Optimizing Medication Use
Examining Feasibility and Effectiveness of an Internet-based Intervention for Facilitating Migraine Medication Adherence and Optimizing Medication Use
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria
- 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.)
Exclusion Criteria
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
|
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:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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.
Tidsram: Post-intervention, at the end of the 1 week study period
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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.
Tidsram: Post-intervention, at the end of the 1 week study period
|
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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Donald B Penzien, PhD, WakeForest School of Medicine
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MK-0974
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