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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| W.G. Bill Hefner Medical Center | FED |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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 and migraine activity (e.g., frequency, impairment) into an existing lifestyle intervention used previously for Veterans at risk for developing Type II diabetes. The principal objectives of this research are to assess the feasibility, acceptability (recruitment), engagement (retention, adherence), and promise of implementing the HELP-VM at the Salisbury. To achieve our objectives, the investigators propose to assess the acceptability of HELP-VM by determining our ability to recruit Veterans to participate in the HELP-VM intervention as administered through the existing structure of the Salisbury VAMC's Whole Health Program, to evaluate the feasibility of implementing HELP-VM by assessing Veterans' adherence to HELP-VM and our capacity to retain them in a clinical trial, and to evaluate the promise of HELP-VM by obtaining preliminary data to estimate variances of primary (headache frequency, headache-related impairment) and secondary/exploratory outcome measures (e.g., emotional distress, use of analgesics/opiates, headache self-efficacy, pain catastrophizing) to inform a future, large-scale trial.
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 experience medically related discharge/retirement, post-traumatic stress disorder, sleep disturbances, and difficulty reintegrating back into civilian life.
Despite advances in our understanding of migraine, it remains poorly understood and often proves refractory to validated drug and non-drug interventions. Therefore, there is tremendous potential value in pursuing alternate intervention pathways for migraine management. Although empirical support remains limited, engagement in regular exercise routinely is recommended for managing and preventing migraine.
This innovative approach, if successful, could be disseminated rapidly to the VAMC in the United States, thereby making a substantial impact on the public health burden of migraine and other lifestyle related chronic diseases amongst our nation's Veterans. Consistent with the VA's Whole Health Initiative, this HELP-VM approach facilitates and supports Veterans' capacity to take charge of their own health and well-being, and recognizes the many health benefits of reducing sedentary activity for migraine and beyond.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive lifestyle intervention | Experimental | The intensive lifestyle intervention used in HELP PD and that will be used in HELP-VM was a modification of the successful Diabetes Prevention Program (DPP) core curriculum adapted for use in groups. The 16-session core curriculum used in DPP, covering key concepts related to energy balance, nutrition, and physical activity, was expanded to include regular sessions focused on group problem-solving of barriers and issues specific to the members and to incorporate presentations from local community groups on topics relevant to healthy living (exercise resources, etc.) The same intervention will be used in HELP-VM and will target moderate intensity physical activity (goal ≥180 min/wk). A DVD series was developed in HELP PD to standardize this core content, improve fidelity of intervention delivery, and to allow the CHWs to focus on group facilitation and problem-solving. This DVD series will also be used in HELP-VM. |
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| Medical Treatment as Usual | No Intervention | Subjects randomized to MTAU will be encouraged to continue engaging in medical treatment as per their usual. The MTAU group will complete baseline and 6-month follow-up assessments, and participants will complete daily symptom self-monitoring on the same schedule as HELP-VM participants. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Lifestyle Intervention | Behavioral | There will be 14 sessions delivered over the course of 6 months; materials consist of CHW lesson plans, participant workbooks, and the DVD series. These materials will be adapted for use in HELP-VM and will include information on migraine and its management as well as mental health resources available to Veterans for common illnesses like depression and post-traumatic stress disorder and modifying physical activity recommendations for Veterans with limited mobility. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability- Number of participants recruited | To assess the acceptability of HELP-VM, the investigators will determine our ability to recruit Veterans to participate in the HELP-VM intervention as administered through the existing structure of the Salisbury VAMC's Whole Health Program | 6 month |
| Percentage of adherence to HELP-VM | To evaluate the feasibility of implementing HELP-VM, the investigators will assess Veterans' adherence to HELP-VM | 6 month |
| Number of participants that complete the intervention | To evaluate the feasibility of implementing HELP-VM, the investigators will assess our capacity to retain them in a clinical trial. | 6 month |
| Mean of primary headache frequency | To evaluate the promise of HELP-VM, the investigators will obtain preliminary data to estimate variances (mean/SD) of primary headache frequency | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy, planning pregnancy and breast feeding (self-report) during screening: Pregnancy, breast feeding, or planning pregnancy within the next year.
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| Name | Affiliation | Role |
|---|---|---|
| Mara Vitolins, PhD | Wake Forest University Health Sciences | Principal Investigator |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |