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

基本信息

批准号：
10062721
负责人：
Jennifer Beth Levin
金额：
$ 75.9万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
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/10062721
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 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 Blood Pressure Monitoring 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 testing functional disability high risk 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 successful intervention trial comparing trial design

项目摘要

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.

项目摘要尽管心血管疾病在美国仍然是一个重大负担，但影响尤其明显患有躁郁症（BD）等精神障碍的人。医疗并发症和早期死亡率 BD和高血压通常与药物依从性不佳和在关心。但是，此类个人的药物不遵守及其对这两者的负面影响心血管和心理健康是一个可能改变的公共健康重要性问题。这拟议的研究，响应PA-18-722：提高患者对治疗和预防的遵守促进健康的方案将评估个性化的以患者为中心的依从性M-Health的影响干预措施被称为个性化发短信，以依从性建筑物 - 心脏血管； ITAB-CV（ITAB-CV）上遵守BD患者的降压药和收缩压。 BD患者与许多有情绪症状的人共同具有认知和功能性需要遵守方法的障碍超越标准教育。有效的方法应有助于参与身体健康和心理健康。 ITAB-CV已在通过简短消息服务（SMS）手机，基于态度 - 社会的修改版本影响效能（ASE）模型，以靶向故意和非义务。改变和维持在这种和类似人群中的依从性，必须解决态度，自我效能感和潜在的态度记忆不足以形成服用药物的习惯。在ITAB-CV的试点试验中，参与者很高参与，在3个月内保留100％，并显示出明显的依从性，减少了收缩压（SBP）和改善精神症状。该项目将以12个月的时间进行前瞻性的2阶段随机对照试验比较了ITAB-CV +血压，情绪的自我监控，并单独服用药物（n = 100）（n = 100）（n = 100）。主要结果是遵守通过自我报告的平板电脑常规问卷（TRQ）和用客观的自动化药帽（ECAP）和收缩压验证，次要结果包括遵守精神药物和精神病症状。 ITAB-CV参与者将重新随机到低频和高频助推器会话，以探索剂量（文本的频率）是否适中长期结局，调查习惯力量作为依从性的介体，并确定变量增强或阻碍依从性。我们还将雇用由关键利益相关者组成的顾问委员会患者，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应进入现有的临床工作流程。 ITAB-CV有可能提高控制不善的人的护理高血压和心理健康合并症。实用的M-Health交付格式将提高适用性将来的混合实施效果试验大规模扩展。