Using mHealth to improve adherence and reduce blood pressure in individuals with hypertension and bipolar disorder

项目总结 虽然心血管疾病在美国仍然是一个沉重的负担，但其影响在 患有精神障碍的人，如双相情感障碍(BD)。这些患者的医疗并发症和早期死亡率 患有BD和高血压的患者通常与服药依从性差和在 关心。然而，这些人中的药物不依从性及其对两者的负面影响 心血管和精神健康是一个潜在的可改变的问题，具有至关重要的公共卫生重要性。这个 建议的研究，针对PA-18-722：提高患者对治疗和预防的依从性 促进健康的养生法，将评估以患者为中心的个性化坚持m-Health的效果 称为个性化短信建立依从性的干预-心血管；ITab-CV(ITab-CV)on BD患者对降压药物的依从性和收缩压。 与许多有情绪症状的个体一样，BD患者具有认知和功能 需要超越标准教育的坚持方法的损害。有效 方法应该有助于参与对身心健康的护理。ITab-CV在 手机通过短消息服务(SMS)，并基于修改版本的态度-社交 影响-效果(ASE)模型，针对故意和非故意不遵守。为了改变和 要在这个群体和类似人群中保持忠诚度，就必须解决态度、自我效能感和前瞻性 记忆力减退，养成服药习惯。在ITab-CV的试点试验中，参与者高度评价 投入使用，在3个月内保持100%，并在依从性方面有显著改善，减少了 收缩压(SBP)和精神症状的改善。本项目为期12个月。 前瞻性两阶段随机对照试验比较ITab-CV+自我监测血压，情绪， 用药组(n=100)和单纯用药组(n=100)。主要结果是坚持 用自报药片常规问卷(TRQ)和 使用客观自动药帽(ECAP)和收缩压进行验证，同时进行二次结果 包括坚持精神药物治疗和精神症状。ITab-CV参与者将重新- 随机进行低频和高频强化治疗，以探索剂量(文本频率)是否有所缓和 长期结果，调查习惯强度作为坚持的中介变量，并确定 加强或阻碍遵守。我们还将聘请一个由主要利益相关者组成的顾问委员会，包括 患者、家庭成员、提供者和行政人员，他们可以帮助告知干预措施是否合适 现有的临床工作流程。ITab-CV有潜力促进对控制不良患者的护理 高血压和精神健康共病。实用的移动健康服务提供格式将增强以下方面的适用性 在未来的混合实施有效性试验中广泛扩大规模。

PROJECT SUMMARY While cardiovascular disease remains a significant burden in the U.S., effects are particularly pronounced in people with mental disorders such as bipolar disorder (BD). Medical complications and early mortality in those with BD and hypertension is often associated with poor medication adherence and sub -optimal engagement in care. However, medication non-adherence among such individuals and its negative impact on both cardiovascular and mental health is a potentially modifiable problem of critical public health importance. The proposed study, written in response to PA-18-722: Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health, will evaluate the effects of a personalized patient-centered adherence m-Health intervention called Individualized Texting for Adherence Building-Cardiovascular; iTAB-CV (iTAB-CV) on adherence to antihypertensive medications and systolic blood pressure in people with BD. In common with many individuals with mood symptoms, BD patients have cognitive and functional impairment that need adherence approaches that go above and beyond standard education. Effective approaches should help engagement in care for both physical and mental health. iTAB-CV is delivered on a mobile phone via Short Message Service (SMS) and is based on a modified version of the Attitude -Social Influence-Efficacy (ASE) model to target both intentional and non-intentional non-adherence. To change and sustain adherence in this and similar populations, one must address attitudes, self-efficacy, and prospective memory deficits to form the habit of medication taking. In a pilot trial of iTAB-CV, participants were highly engaged, with 100% retention over 3 months and showed significant improvement in adherence, reduction in systolic blood pressure (SBP), and improved psychiatric symptoms. This project will be conducted as a 12-month prospective 2-stage randomized controlled trial comparing iTAB-CV + Self-Monitoring of blood pressure, mood, and medication taking (n=100) to Self-Monitoring alone (n=100). The primary outcome is adherence to antihypertension medication as measured by the self-reported Tablets Routine Questionnaire (TRQ) and validated with objective automated pill caps (eCAP) and systolic blood pressure while secondary outcomes include adherence to psychiatric medication and psychiatric symptoms. iTAB-CV participants will be re- randomized to low and high frequency booster sessions to explore whether dose (frequency of text) moderates longer-term outcome, to investigate habit strength as a mediator of adherence and identify variables that enhance or impede adherence. We will also employ an advisory board made up of key stakeholders including patients, family members, providers, and administrative staff who can help inform how the intervention might fit into existing clinical workflows. iTAB-CV has potential to advance care for people with poorly controlled hypertension and mental health comorbidity. The practical, m-Health delivery format will enhance suitability for broad scale-up in future hybrid implementation-effectiveness trials.