A Pilot Sensor-controlled Digital Gaming Intervention With Real-time Behavior Tracking to Motivate Self-management Behaviors in Older Adults With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks
研究概览
简要总结
This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of weight monitoring and physical activity in older adults with heart failure (HF). Half of the participants will receive the SCDG app and weight monitoring and physical activity sensors and the other half will receive only the weight monitoring and physical activity sensors.
详细描述
The primary goal of this study is to obtain initial efficacy data and undertake a comprehensive feasibility assessment of a SCDG intervention that synchronizes with a Bluetooth-enabled weight scale and activity tracker to activate game rewards and feedback based on older adult heart failure (HF) participants' real-time weight monitoring and exercise behaviors.
The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid rehospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal HF health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app. The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback (e.g., reduce fluid intake or call doctor for weight gain) to motivate engagement in and generate habit formation of heart failure related self-management behaviors. The goal of this proposal is to demonstrate the feasibility of the SCDG concept with an optimal number of sensors in a small study so as to lay a foundation for scaling this concept to include more relevant sensors in longer, larger studies.
In this study, the initial efficacy of the SCDG intervention for primary outcome of rate of engagement in HF self-management behavior of weight-monitoring and secondary outcomes of physical activity engagement, HF self-management-knowledge, and self-efficacy, HF-functional status, hospitalization, cognitive ability, depression and quality of life will be evaluated. For this study, 44 older adults diagnosed with the New York Heart Association's HF classification I to III from out-patient HF settings in central Texas will be recruited, and randomized to either the SCDG intervention group that will receive sensors tracking weight monitoring and activity and play the SCDG on a mobile smartphone for 12 weeks or a control group that will receive sensors and an app tracking activity and weight monitoring, and standardized written HF educational modules.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 支持治疗
- 盲法
- 双盲 (受试者、结局评估者)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Age 55 years or older
- New York Heart Association (NYHA) heart failure classification of I to III that permits minimal physical activity without discomfort
- Understand English
- Pass a mini-cognitive screen
- Score of less than 2 (able to independently walk without using a cane or walker) on the Outcome and Assessment Information Set item for ambulation/locomotion
- Ownership of a smartphone or digital tablet
排除标准
- Severe visual (e.g., legally blind) or tactile (e.g., severe arthritis) impairments that adversely prevent the use of a smartphone or sensor devices
- History of renal failure which adversely affects heart failure prognosis
- Diagnosis of an end stage or terminal illness (e.g., cancer).
研究组 & 干预措施
Intervention Group
The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors
干预措施: Sensor-controlled digital game (SCDG) (Behavioral)
Control group
The control group will receive only the weight monitoring and physical activity sensors
干预措施: Sensor Only (Behavioral)
方案终点
主要结局
Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks
时间窗: 6 weeks
This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG).
Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks
时间窗: 12 weeks
This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG).
次要结局
- Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 6 Weeks(Baseline, 6 weeks)
- Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 24 Weeks(Baseline, 24 weeks)
- Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks(Baseline, 12 weeks)
- Number of Heart Failure Hospitalizations in the Past 6 Months at End of 24 Weeks as Assessed by Self-report(Baseline, 24 weeks)
- Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 24 Weeks(Baseline,24 weeks)
- Number of Days With Physical Activity on Sensor Logs at 12 Weeks(12 weeks)
- Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks(6 weeks)
- Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks(12 weeks)
- Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 6 Weeks(Baseline, 6 weeks)
- Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 12 Weeks(Baseline, 12 weeks)
- Number of Heart Failure Hospitalizations in the Past Month at End of 24 Weeks as Assessed by Self-report(Baseline, 24 weeks)
- Number of Days With Physical Activity on Sensor Logs at 6 Weeks(6 weeks)
- Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks(Baseline, 6 weeks)
- Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks(Baseline, 24 weeks)
- Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks(Baseline, 6 weeks)
- Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks(Baseline, 24 weeks)
- Number of Heart Failure Hospitalizations in the Past Month at End of 6 Weeks as Assessed by Self-report(Baseline, 6 weeks)
- Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 6 Weeks(Baseline, 6 weeks)
- Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 24 Weeks(Baseline, 24 weeks)
- Number of Heart Failure Hospitalizations in the Past Month at End of 12 Weeks as Assessed by Self-report(Baseline, 12 weeks)
- Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 24 Weeks(Baseline, 24 weeks)
- Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 6 Weeks(Baseline, 6 weeks)
- Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 12 Weeks(Baseline, 12 weeks)
试验结果
结果已于 2021-06-28 在 ClinicalTrials.gov 公示。 在 ClinicalTrials.gov 查看
受试者流程
入组 38 人 · 完成 27 人
主要终点
Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks
days · Standard Deviation · 时间窗: 6 weeks
| Intervention Group （n=15） | Control Group （n=17） |
|---|---|
| 35.8 (6.0) | 32.9 (10.5) |
Based on participants available for data collection at 6 weeks.
Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks
days · Standard Deviation · 时间窗: 12 weeks
| Intervention Group （n=15） | Control Group （n=17） |
|---|---|
| 69.7 (16.1) | 60.1 (18.7) |
Based on participants available for data collection at 12 weeks.
其他终点（26）
Number of Days With Physical Activity on Sensor Logs at 6 Weeks
Days · Standard Deviation · 时间窗: 6 weeks
| Intervention Group （n=15） | Control Group （n=16） |
|---|---|
| 36.7 (10.9) | 39.2 (6.6) |
Based on participants available for data collection at 6 weeks.
Number of Days With Physical Activity on Sensor Logs at 12 Weeks
days · Standard Deviation · 时间窗: 12 weeks
| Intervention Group （n=15） | Control Group （n=16） |
|---|---|
| 76.6 (11.02) | 69.6 (17.3) |
Based on participants available for data collection at 12 weeks.
Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks
steps · Standard Deviation · 时间窗: 6 weeks
| Intervention Group （n=15） | Control Group （n=16） |
|---|---|
| 2742 (2499) | 2638 (1573) |
Based on participants available for data collection at 6 weeks.
Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks
steps · Standard Deviation · 时间窗: 12 weeks
| Intervention Group （n=15） | Control Group （n=16） |
|---|---|
| 2887 (2821) | 2541 (1604) |
Based on participants available for data collection at 12 weeks.
Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 6 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 6 weeks
| Intervention Group （n=15） | Control Group （n=15） |
|---|---|
| 4.9 (20.4) | -2.7 (9.9) |
Based on participants available for data collection for this measure at 6 weeks.
Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 12 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 12 weeks
| Intervention Group （n=15） | Control Group （n=16） |
|---|---|
| 9.3 (16.5) | 2.6 (12.4) |
Based on participants available for data collection for this measure at 12 weeks.
Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 24 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 24 weeks
| Intervention Group （n=12） | Control Group （n=13） |
|---|---|
| 10.2 (13.4) | 0.5 (9.8) |
Based on participants available for data collection for this measure at 24 weeks.
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 6 weeks
| Intervention Group （n=14） | Control Group （n=16） |
|---|---|
| 5.8 (13.1) | 8.7 (15.3) |
Based on participants available for data collection for this measure at 6 weeks.
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 12 weeks
| Intervention Group （n=14） | Control Group （n=16） |
|---|---|
| 8.2 (13.5) | 13.0 (19.3) |
Based on participants available for data collection for this measure at 12 weeks.
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 24 weeks
| Intervention Group （n=13） | Control Group （n=13） |
|---|---|
| 10.8 (16.9) | 15.4 (19.6) |
Based on participants available for data collection for this measure at 24 weeks.
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 6 weeks
| Intervention Group （n=14） | Control Group （n=16） |
|---|---|
| 6.9 (14.1) | 1.7 (11.8) |
Based on participants available for data collection for this measure at 6 weeks.
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 12 weeks
| Intervention Group （n=14） | Control Group （n=16） |
|---|---|
| 3.7 (14.1) | 4.1 (12.6) |
Based on participants available for data collection for this measure at 12 weeks.
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 24 weeks
| Intervention Group （n=13） | Control Group （n=13） |
|---|---|
| 7.4 (10.7) | 6.5 (11.7) |
Based on participants available for data collection for this measure at 24 weeks.
Number of Heart Failure Hospitalizations in the Past 6 Months at End of 24 Weeks as Assessed by Self-report
hospitalizations · 时间窗: Baseline, 24 weeks
| Intervention Group （n=13） | Control Group （n=13） |
|---|---|
| 2 | 2 |
Based on participants available for data collection for this measure at 24 weeks.
Number of Heart Failure Hospitalizations in the Past Month at End of 12 Weeks as Assessed by Self-report
hospitalizations · 时间窗: Baseline, 12 weeks
| Intervention Group （n=15） | Control Group （n=16） |
|---|---|
| 0 | 1 |
Based on participants available for data collection for this measure at 12 weeks.
Number of Heart Failure Hospitalizations in the Past Month at End of 6 Weeks as Assessed by Self-report
hospitalizations · 时间窗: Baseline, 6 weeks
| Intervention Group （n=15） | Control Group （n=16） |
|---|---|
| 1 | 1 |
Based on participants available for data collection for this measure at 6 weeks.
Number of Heart Failure Hospitalizations in the Past Month at End of 24 Weeks as Assessed by Self-report
hospitalizations · 时间窗: Baseline, 24 weeks
| Intervention Group （n=13） | Control Group （n=13） |
|---|---|
| 1 | 0 |
Based on participants available for data collection for this measure at 24 weeks.
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 6 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 6 weeks
| Intervention Group （n=14） | Control Group （n=16） |
|---|---|
| 1.9 (2.5) | 2.1 (2.5) |
Based on participants available for data collection for this measure at 6 weeks.
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 12 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 12 weeks
| Intervention Group （n=14） | Control Group （n=16） |
|---|---|
| 1.4 (1.7) | 1.1 (1.5) |
Based on participants available for data collection for this measure at 12 weeks.
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 24 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline,24 weeks
| Intervention Group （n=12） | Control Group （n=13） |
|---|---|
| 1.1 (2.1) | 1.1 (2.7) |
Based on participants available for data collection for this measure at 24 weeks.
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 24 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 24 weeks
| Intervention Group （n=12） | Control Group （n=13） |
|---|---|
| 3.0 (18.0) | 7.0 (16.5) |
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 12 weeks
| Intervention Group （n=14） | Control Group （n=16） |
|---|---|
| 1.0 (20.5) | 10.2 (12.3) |
Based on participants available for data collection for this measure at 12 weeks.
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 6 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 6 weeks
| Intervention Group （n=14） | Control Group （n=16） |
|---|---|
| 2.2 (25.7) | 6.9 (18.1) |
Based on participants available for data collection for this measure at 6 weeks.
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 6 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 6 weeks
| Intervention Group （n=14） | Control Group （n=17） |
|---|---|
| -0.1 (1.2) | -0.2 (2.2) |
Based on participants available for data collection for this measure at 6 weeks.
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 12 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 12 weeks
| Intervention Group （n=14） | Control Group （n=17） |
|---|---|
| 0.1 (2.6) | -0.3 (3.0) |
Based on participants available for data collection for this measure at 12 weeks.
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 24 Weeks
score on a scale · Standard Deviation · 时间窗: Baseline, 24 weeks
| Intervention Group （n=13） | Control Group （n=13） |
|---|---|
| -0.6 (2.5) | -0.2 (2.7) |
Based on participants available for data collection for this measure at 24 weeks.
安全性
| 组别 | 严重不良事件 | 死亡 |
|---|---|---|
| Intervention Group | 0 / 19 | 0 / 19 |
| Control Group | 0 / 19 | 0 / 19 |
数值为申办方在 ClinicalTrials.gov 公示的原始数据，未经重新计算；括号内为公示的离散度（如 95% 置信区间）。
相关文献
- 相关文献（PubMed 关联）Radhakrishnan K, Julien C, Baranowski T, O'Hair M, Lee G, Sagna De Main A, Allen C, Viswanathan B, Thomaz E, Kim M. Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. JMIR Serious Games. 2021 Nov 8;9(4):e29044. doi: 10.2196/29044. PubMed 34747701
研究者
研究点 (2)
标识符
- NCT 编号
- NCT03947983
- 其他研究编号
- 201800216-001, R21NR018229
日期
- 首次提交
- (7年前)
- 首次发布
- (7年前)
- 主要完成日期
- (5年前)
- 研究完成日期
- (5年前)
- 最近核实
- (5年前)
- 最近更新
- (5年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 是