HeadacheNCT02473692
Facilitating Migraine Medication Adherence and Optimizing Medication Use
An observational study of Headache, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache
- What is being tested?
- Online Migraine Treatment Optimization
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.)
Who cannot join
- 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
About this study
Official title: Examining Feasibility and Effectiveness of an Internet-based Intervention for Facilitating Migraine Medication Adherence and Optimizing Medication Use
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).
Read the 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.
- Conditions
- Headache
- Being tested
- Online Migraine Treatment Optimization
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Migraine Treatment OptimizationOther
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:
- Introduction to the series
- Getting to know migraine
- Making the most of your medical care
- Partnering with your doctor
- Best use of migraine medication
- Keeping tabs on your migraine
- Take home message (summary)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Online Migraine Treatment Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Post-intervention, at the end of the 1 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJun 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Delays in start date led to termination of the study prior to recruitment of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Donald B Penzien, PhD, Principal investigator, WakeForest School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473692
- Sponsor's protocol ID
- MK-0974
- Status last verified
- Aug 2017
- First submitted
- 29 May 2015
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Feasibility and Effectiveness of an Internet-based Intervention for Facilitating Migraine Medication Adherence and Optimizing Medication Use
- ClinicalTrials.gov ID
- NCT02473692
- Acronym / sponsor ID
- MK-0974
- Conditions
- Headache
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Delays in start date led to termination of the study prior to recruitment of participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online MigraineTreatment Optimization | – | Other: Online Migraine Treatment OptimizationAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- Adults >= 18 year-old
- Any self-reported headache disorder, from any etiology ( > 5 attacks, lifetime)
- Self-reported use of any headache abortive treatment:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Migraine Treatment OptimizationThe 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) | Other | Online MigraineTreatment Optimization |
Primary outcome
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.
Time frame: 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.
1 secondary outcome
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.
Time frame: Post-intervention, at the end of the 1 week study period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald B Penzien, PhD principal investigator
WakeForest School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Post-intervention, at the end of the 1 week study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.