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：
10544503
负责人：
Kavita Radhakrishnan
金额：
$ 73.62万
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/10544503
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 Disparity Ecological momentary assessment Education Educational Materials Elderly Electronics Equilibrium Face Feasibility Studies Feedback Foundations Geographic Locations Geography Goals Habits Health Health Promotion Healthcare Heart Heart failure Home Hospitalization 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 Writing age group aged behavior change behavioral adherence behavioral outcome care burden 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.

项目概要/摘要心力衰竭 (HF) 在美国是一种日益流行的疾病，预计诊断出心力衰竭的人数将增加到 2030 年，心力衰竭患者将增至 800 万，年费用将达到 690 亿美元。尽管采取了有效的干预措施来降低心力衰竭发病率和死亡率，患有心力衰竭的弱势人群住院和死亡的比例不成比例尤其是在美国南部各州，通过自我管理 (SM) 行为干预来改善心力衰竭。因此，促进 SM 行为的远程干预至关重要。解决心力衰竭结果中不断扩大的地理和种族健康差异的战略。方法是使用传感器控制的数字游戏 (SCDG)，它提供价格实惠、便携、可扩展的工具促进参与表现出最差依从性的 HF SM 行为（体重监测和身体检查）活动），同时令人愉快且易于使用。本研究的主要目标是评估一项活动的功效。 SCDG 干预整合了来自体重秤和活动追踪器的 HF 参与者的行为数据传感器来激活游戏进度、奖励和反馈对于目标 1，我们将完善现有的 SCDG。已经为移动智能手机开发，可玩更长时间以实现持续行为对于目标 2，我们使用随机对照临床试验来坚持体重监测和身体活动。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 行为和体力活动的次要结果行为参与、心力衰竭 SM 知识、自我效能、心力衰竭功能状态、住院情况和生活质量在基线以及第 6、12 和 24 周时，我们将招募 7 周岁或以上的 45 岁成年人。过去 6 个月内因心力衰竭住院的美国南部各州的参与者我们将随机抽取 200 名参与者。 SCDG 干预组，参与者将收到跟踪体重监测和活动，并将在移动智能手机上播放 SCDG，或将接收传感器、应用程序的对照组跟踪活动和体重监测以及标准化书面 HF 教育材料。将进行混合方法评估，以识别影响参与者的促进因素和障碍参与基于传感器的干预措施，以实现目标 4 的 HF SM 行为依从性，基于每日 HF。 SM体重监测和身体活动行为数据以及生态瞬时评估症状、情绪、满意度和认知状态，我们将对 HF SM 体重进行数字表型分析该项目将为可扩展和身体活动行为提供见解和指导。易于使用的数字游戏解决方案，可激励持续遵守 HF SM 行为并改善健康心力衰竭患者的结果。