Status:
WITHDRAWN
Healthy Living Partnerships for Veterans With Migraine
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
W.G. Bill Hefner Medical Center
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Migraine
Migraine Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot study, modeled upon the successful and empirically validated HELP Prevent Diabetes Intervention, incorporates a migraine education component describing the links between lifestyle behaviors...
Detailed Description
Headache disorders such as migraine occur commonly among Veterans and contribute to disability and reduced quality of life. Veterans with migraine are more likely than those without headache to experi...
Eligibility Criteria
Inclusion
- Demographics: Community dwelling men and women Veterans (21 years of age and older) of all races/ethnicities seen as patients at the Kernersville Health Care Center.
- Headache Diagnosis, frequency, and chronicity: All participants will be required to have a diagnosis of chronic migraine as per ICHD-IIIβ criteria24. Those with headache frequency ≥ 15 headache days per month for more than three months will be eligible to participate.
- Willingness to Accept Randomization: Prospective participants must be willing to accept randomization to either the intensive lifestyle intervention or the comparison intervention condition.
- Baseline Physician Activity Level: At the time of enrollment, prospective participants must not be participating in a regular physical activity or exercise regimen, and should meet the criteria for "sedentary" (i.e., does not report current engagement in vigorous or moderate activity) on the International Physical Activity Questionnaire Short form (IPAQ-SF).
Exclusion
- Other painful conditions: A diagnosis of headache disorder other than chronic migraine (eg, cluster headache or medication overuse headache as per ICHD-IIIβ criteria24) or characterizes a pain disorder other than migraine as their primary presenting problem.
- Non-stable headache treatment regimen: Reports a change in physician prescribed preventive or acute headache pharmacotherapy within three weeks prior to enrollment or anticipates a change in preventive headache pharmacotherapy during the study period.
- Recent history of cardiovascular disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure. All persons with recent CVD should be participating in cardiac rehabilitation (with appropriate supervision as indicated) to reduce their risk of recurrence; hence, randomization might raise ethical concerns.
- Hypertension: Uncontrolled high blood pressure: BP \> 160/100 mmHg. Potential participants can be re-screened after controlled.
- Pregnancy, planning pregnancy and breast feeding (self-report) during screening: Pregnancy, breast feeding, or planning pregnancy within the next year.
- Physical preparedness for exercise: Those screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)25 those must obtain physician clearance prior to participation, and will be excluded unless the clearance is obtained and documented.
- Other Medical and Psychiatric Conditions: Candidates will be screened for other co-morbid conditions that could make physical activity unsafe or limit participation. This includes other chronic disease likely to limit lifespan to less than 2-3 years (eg, any cancer requiring treatment in past 5 years except non-melanoma skin cancer), elevated depressive symptoms and/or suicidal ideation (Patient Health Questionnaire (PHQ-9)28,29), anxiety levels that could interfere with participation in this trial (PROMIS-29 Anxiety Subscale30-32, and evidence of opioid use disorder (Current Opioid Misuse Measure (COMM)33).
- Other: Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP-VM, evidence of major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), participation in another research study that would interfere with HELP-VM.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04373330
Start Date
June 1 2025
End Date
June 1 2026
Last Update
July 2 2025
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