Sensor-controlled digital game for heart failure self-management behavior adherence: A randomized controlled trial

用于心力衰竭自我管理行为依从性的传感器控制数字游戏：一项随机对照试验

基本信息

批准号：
10340575
负责人：
Kavita Radhakrishnan
金额：
$ 64.39万
依托单位：
UNIVERSITY OF TEXAS AT AUSTIN
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-12-29 至 2025-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10340575
关键词：
Accelerometer Active Learning Address Adherence Adult Age Behavior Behavior Therapy Behavioral Behavioral Model Biometry Cardiac health Cellular Phone Chronic Disease Clinical Trials Cognitive Control Groups Data Diabetes Mellitus Diagnosis Ecological momentary assessment Educational Materials Elderly Equilibrium Face Feasibility Studies Feedback Foundations Geographic Locations Geography Goals Habits Health Health Promotion Healthcare Heart Heart failure Home Hospitalization Immersion Incentives Individual Intervention Knowledge Knowledge Management Life Style Measures Methods Monitor Moods Morbidity - disease rate Motivation Oklahoma Outcome Participant Pattern Pharmaceutical Preparations Phenotype Physical activity Play Precision Health Prevention Psychology Quality of life Randomized Randomized Controlled Clinical Trials Randomized Controlled Trials Recommendation Regimen Resources Rewards Sampling Self Efficacy Self Management Software Engineering Standardization Symptoms Technology Texas Time Vulnerable Populations Weight Weight maintenance regimen age group aged base behavior change behavioral adherence behavioral outcome compliance behavior cost design digital effective intervention efficacy evaluation evidence base feasibility trial functional status group intervention health disparity hospital readmission impaired functional status improved individual response innovation insight mortality pandemic disease patient engagement portability primary outcome processing speed prospective racial health disparity recruit remote intervention response satisfaction scale up secondary outcome sensor skills social tool

项目摘要

PROJECT SUMMARY/ABSTRACT Heart failure (HF) is a growing pandemic; in the U.S., the number of those diagnosed with HF is expected to rise to 8 million with annual costs at $69 billion by 2030. Despite effective interventions to reduce HF morbidity and mortality, vulnerable populations with HF suffer disproportionately from hospitalization and mortality especially in the southern U.S. states. Self-management (SM) behavioral interventions to improve HF outcomes are therefore imperative. Remote interventions to promote SM behaviors present an important strategy to address the widening geographical and racial health disparities in HF outcomes. One promising approach is the use of sensor-controlled digital games (SCDGs), which offer affordable, portable, scalable tools to facilitate engagement in HF SM behaviors that show the poorest adherence (weight monitoring and physical activity) while being enjoyable and easy to use. The primary goal of this study is to evaluate the efficacy of a SCDG intervention that integrates HF participants’ behavioral data from weight scale and activity tracker sensors to activate game progress, rewards, and feedback. For Aim 1, we will refine an SCDG that we have already developed for mobile smartphones to be playable for longer durations for sustained behavior adherence to weight-monitoring and physical activity. For Aim 2, using a randomized controlled clinical trial, we will compare the SCDG intervention versus a sensor-only intervention for the primary outcome of rate of engagement in the HF SM behavior of weight-monitoring and the secondary outcomes of physical activity behavior engagement, HF SM knowledge, self-efficacy, HF functional status, hospitalization, and quality of life at baseline and at 6, 12, and 24 weeks. For our sample, we will recruit adults aged 45 years or older from 7 southern U.S. states and hospitalized with HF within the past 6 months. We will randomize 200 participants to either the SCDG intervention group, in which participants will receive sensors that track weight monitoring and activity and will play the SCDG on a mobile smartphone, or a control group that will receive sensors, an app that tracks activity and weight monitoring, and standardized written HF educational materials. For Aim 3, we will conduct a mixed-methods assessment to discern facilitators and barriers impacting participants’ engagement with the sensor-based interventions for HF SM behavior adherence. For Aim 4, based on daily HF SM weight-monitoring and physical activity behavior data and ecological momentary assessments of symptoms, mood, satisfaction, and cognitive status, we will conduct digital phenotyping of HF SM weight- monitoring and physical activity behaviors. This project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF SM behaviors and improve health outcomes among individuals with HF.

项目摘要/摘要心力衰竭（HF）是日益增长的大流行。在美国，被诊断为HF的人数预计到2030年，每年成本增加到800万美元，每年成本为690亿美元。尽管有效干预了HF发病率和死亡率，HF的脆弱人群因住院和死亡率不成比例特别是在美国南部州。自我管理（SM）行为干预以改善HF 因此，结果是必须的。促进SM行为的远程干预措施提出了重要的解决HF结果中地理和种族健康差异扩大的策略。一个诺言方法是使用传感器控制的数字游戏（SCDG），可提供负担得起，便携式，可扩展的工具促进参与HF SM行为，表现出最差的依从性（体重监测和身体活动）虽然很愉快且易于使用。这项研究的主要目的是评估 SCDG干预措施将HF参与者的行为数据整合在体重量表和活动跟踪器中传感器激活游戏的进度，奖励和反馈。对于AIM 1，我们将完善我们拥有的SCDG 已经为移动智能手机开发了更长的持续行为的持续时间遵守体重监控和体育锻炼。对于AIM 2，使用随机对照临床试验，我们将比较SCDG干预与仅传感器干预的主要结果参与体重监测的HF SM行为和体育活动的次要结果行为参与，HF SM知识，自我效能感，HF功能状况，住院和生活质量在基线和6、12和24周时。对于我们的样本，我们将招募从7岁以上的45岁以上的成年人美国南部各州，并在过去6个月内与HF住院。我们将将200名参与者随机 SCDG干预组，参与者将收到跟踪体重监控和的传感器活动并将在移动智能手机上播放SCDG，或将接收传感器的对照组，应用程序跟踪活动和体重监控，并标准化的书面HF教育材料。对于目标3，我们将进行混合方法评估，以辨别促进者和影响参与者的障碍参与基于传感器的HF SM行为依从性的干预措施。对于AIM 4，基于每日HF SM重量监控和体育活动行为数据以及对症状，情绪，满意度和认知状况，我们将进行HF SM重量的数字表型 - 监测和体育锻炼行为。该项目将为可扩展和指导产生洞察力和指导易于使用的数字游戏解决方案，以融合持续遵守HF SM行为并改善健康状况 HF患者的结果。