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: 10396675
• 负责人: Jennifer Beth Levin
• 金额: $ 76.09万
• 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/10396675
• 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; future implementation; high risk; hypertensive; implementation efforts; improved; intervention delivery; 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 influence; 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.

项目概要 虽然心血管疾病在美国仍然是一个重大负担，但其影响在以下国家尤其明显： 患有双相情感障碍 (BD) 等精神障碍的人。那些人的医疗并发症和早期死亡 BD 和高血压患者通常与药物依从性差和参与度不佳有关 关心。然而，这些人不遵守药物治疗及其对两者的负面影响 心血管和心理健康是一个具有重要公共卫生重要性的潜在可改变问题。这 拟议的研究，针对 PA-18-722 撰写：提高患者对治疗和预防的依从性 促进健康的方案将评估以患者为中心的个性化依从性移动健康的效果 名为“个体化短信促进心血管依从性建设”的干预措施； iTAB-CV（iTAB-CV）开启 BD 患者坚持抗高血压药物和收缩压。 与许多有情绪症状的人一样，双相情感障碍患者也有认知和功能障碍 需要超越标准教育的坚持方法的障碍。有效的 方法应有助于参与身心健康护理。 iTAB-CV 交付于 移动电话通过短信服务 (SMS) 并基于 Attitude -Social 的修改版本 影响效力（ASE）模型针对有意和无意的不遵守情况。改变和 要在这一人群和类似人群中保持依从性，必须解决态度、自我效能和未来发展的问题。 记忆力减退，形成服药习惯。在 iTAB-CV 的试点试验中，参与者高度评价 参与度高，在 3 个月内保持 100%，并且依从性显着提高，减少了 收缩压（SBP），并改善精神症状。该项目将为期 12 个月 比较 iTAB-CV + 血压、情绪、自我监测的前瞻性 2 阶段随机对照试验 服用药物（n=100）到单独自我监测（n=100）。主要结果是坚持 通过自我报告的片剂常规问卷 (TRQ) 测量的抗高血压药物和 通过客观自动药帽 (eCAP) 和收缩压进行验证，同时次要结果 包括坚持精神科药物治疗和精神科症状。 iTAB-CV 参与者将重新 随机进行低频和高频加强课程，以探讨剂量（文本频率）是否适度 长期结果，调查习惯强度作为依从性的中介因素并确定变量 增强或阻碍依从性。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、提供者和行政人员可以帮助告知干预措施如何适合 纳入现有的临床工作流程。 iTAB-CV 有潜力促进对控制不佳的人的护理 高血压和心理健康合并症。实用的移动医疗交付格式将增强对以下人群的适用性： 在未来的混合实施有效性试验中广泛扩大规模。