Healthy Living Partnerships for Veterans With Migraine
关键词
抽象
描述
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.
日期
最后验证: | 04/30/2020 |
首次提交: | 04/28/2020 |
提交的预估入学人数: | 04/28/2020 |
首次发布: | 05/03/2020 |
上次提交的更新: | 06/25/2020 |
最近更新发布: | 06/29/2020 |
实际学习开始日期: | 07/31/2020 |
预计主要完成日期: | 07/30/2021 |
预计完成日期: | 07/30/2021 |
状况或疾病
干预/治疗
Behavioral: Intensive lifestyle intervention
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Intensive lifestyle intervention 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. | Behavioral: Intensive lifestyle intervention 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. |
No Intervention: Medical Treatment as Usual 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. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - 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 Criteria: - 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. |
结果
主要结果指标
1. Acceptability- Number of participants recruited [6 month]
2. Percentage of adherence to HELP-VM [6 month]
3. Number of participants that complete the intervention [6 month]
4. Mean of primary headache frequency [6 month]