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

使用移动医疗提高高血压和双相情感障碍患者的依从性并降低血压

• 批准号: 10241528
• 负责人: Jennifer Beth Levin
• 金额: $ 74.65万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-17 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10241528
• 关键词: Accounting; Acute; Address; Adherence; Antihypertensive Agents; Attitude; Behavior; Bipolar Disorder; Blood Pressure; Car Phone; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Chronic; Clinical; Dose; Education; Event; Family member; Frequencies; Future; General Population; Habits; Health; Health Benefit; Health Promotion; Home Blood Pressure Monitoring; Hypertension; Impaired cognition; Individual; Intervention; Length; Measures; Mediation; Mediator of activation protein; Medical; Memory impairment; Mental Depression; Mental Health; Mental disorders; Modeling; Modification; Monitor; Moods; Motivation; Outcome; Participant; Patient Care; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Population; Prevention; Primary Care Physician; Primary Health Care; Provider; Public Health; Questionnaires; Randomized; Randomized Controlled Trials; Regimen; Risk; Self Efficacy; Tablets; Technology; Testing; Text; Text Messaging; Time; base; blood pressure reduction; cardiovascular health; comorbidity; compliance behavior; effectiveness implementation study; effectiveness implementation trial; effectiveness trial; efficacy evaluation; efficacy testing; functional disability; high risk; implementation efforts; improved; mHealth; medical complication; medication compliance; medication nonadherence; mood symptom; mortality; patient oriented; patient subsets; physical conditioning; pill; pilot trial; post intervention; premature; primary outcome; prospective; prospective memory; psychiatric symptom; psychoeducational; response; scale up; secondary outcome; social; trial comparing; trial design

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.

项目摘要 虽然心血管疾病仍然是美国的一个重大负担，影响尤其明显， 患有双相情感障碍（BD）等精神障碍的人。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药物依从性差和次优参与有关。 在乎然而，这些人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具有重大公共卫生意义的潜在可改变的问题。的 拟定的研究，为回应PA-18-722：提高患者对治疗和预防的依从性而撰写 方案，以促进健康，将评估个性化的以患者为中心的坚持m-Health的效果 干预称为个体化短信建立依从性-心血管; iTAB-CV（iTAB-CV） BD患者的抗高血压药物依从性和收缩压。 与许多具有情绪症状的个体一样，BD患者具有认知和功能障碍。 需要坚持的方法，超越标准教育的障碍。有效 各种方法应有助于参与身心健康护理。iTAB-CV在 移动的电话通过短消息服务（SMS）和基于修改版本的态度-社会 影响-功效（ASE）模型，以有意和无意的不依从为目标。改变和 在这一人群和类似人群中维持依从性，必须解决态度、自我效能和预期 记忆力减退形成服药习惯。在iTAB-CV的试点试验中，参与者高度 参与，3个月内保持100%，并显示出依从性的显著改善， 收缩压（SBP），精神症状改善。该项目将作为一个为期12个月的 比较iTAB-CV +自我监测血压、情绪 服药组（n=100）与自我监测组（n=100）比较。主要结局是依从性 通过自我报告的片剂常规问卷（TRQ）测量的抗高血压药物， 通过客观自动药丸帽（eCAP）和收缩压进行验证， 包括坚持精神病药物治疗和精神病症状。iTAB-CV参与者将重新 随机分配至低频率和高频率加强治疗，以探索剂量（文本频率）是否会调节 长期结果，调查习惯强度作为坚持的中介，并确定变量， 增强或阻碍粘附。我们还将聘请一个由主要利益相关者组成的咨询委员会， 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如何适合 现有的临床工作流程。iTAB-CV有可能改善控制不良患者的护理 高血压与精神健康共病实用的m-Health交付格式将提高适用性， 在未来的混合执行效果试验中广泛扩大规模。