A Sensor-controlled Digital Game-based Approach to Improve Self-care Behaviors Among Adults Diagnosed With Hypertension in a Native American Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Mean of Daily Steps on Physical Activity Sensor Logs at 6 months
研究概览
简要总结
This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of physical activity in Native American adults with hypertension (HTN). Half of the participants will receive the SCDG app and physical activity sensors and the other half will receive only the physical activity sensors.
Native American participants with hypertension (HTN) in the sensor controlled digital game intervention group will show increased PA behaviors; improved HTN knowledge, self-care behaviors, self-efficacy, motivation, and quality of life (QoL); and larger reduction in systolic and diastolic blood pressure and cardiac hospitalizations at baseline,3 months, and 6 months as compared to participants in the sensor-only control group.
详细描述
Cardiovascular disease is the leading cause of death among Native Americans (NAs). Hypertension (HTN) strongly elevates the morbidity and mortality risks related to cardiovascular disease. Lifestyle modifications promoted by U.S. HTN guidelines includes modifiable self-care behaviors such as regular physical activity which is associated with lower blood pressure, reduced cardiovascular risk, and beneficial cardiac structural remodeling. Therefore, motivating physical activity behaviors would be key to cardiovascular health promotion efforts among a Native American community.
One promising approach is the use of sensor-controlled digital games (SCDGs), which offer affordable, portable, and scalable tools to facilitate engagement in HTN self-care behaviors while being enjoyable and easy to use. The SCDG intervention integrates HTN participants' behavioral data from an activity tracker sensor to activate game progress, rewards, and feedback. The primary goal of this study is to test a culturally adapted SCDG intervention (N-SCDG) for improving daily physical activity self-care behaviors among Lumbee tribal adults with HTN and examine approaches for sustaining the impact of the N-SCDG at the community level.
The investigators will compare the N-SCDG intervention versus a sensor-only control for the primary outcome of engagement in the HTN selfcare behavior of physical activity and the secondary outcomes of HTN self-care knowledge, self-care behaviors, self-efficacy, systolic and diastolic blood pressure, cardiac hospitalization, and quality of life at baseline, 3 months, and 6 months. The investigators will randomize 220 participants to either the N-SCDG intervention group, in which participants will receive sensors that track physical activity and will play the N-SCDG on a mobile smart phone, or a control group that will receive sensors, an app that tracks physical activity, and standardized written HTN educational materials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults in a Native American tribal community in southeastern U.S.
- •Age 18 years or older
- •Systolic BP ≥140mm Hg and/or diastolic BP ≥90mm Hg on 2 separate measurements or who are on antihypertensive medication will be included.
- •Pass a mini-cognitive screen
- •Able to independently walk without using a walker or requiring human assistance (ambulation/locomotion item on the Outcome and Assessment Information).
排除标准
- •Severe visual (e.g., legal blindness) or tactile (e.g., severe arthritis) impairments that adversely prevent use of a smart phone or sensor devices;
- •Chronic kidney disease stage 4-5,
- •Diagnosis of end stage or terminal illness (e.g., cancer or heart failure)
- •Prior heart transplantation or implantation of a durable mechanical circulatory support device (e.g., left ventricular assist devise) due to unique self-care needs.
研究组 & 干预措施
Sensor-controlled digital game
The intervention group will receive a sensor-controlled digital game (SCDG) app and physical activity tracker.
干预措施: Sensor-controlled digital game (Behavioral)
Sensor-only
The control group will receive only the physical activity tracker.
干预措施: Sensor only (Behavioral)
结局指标
主要结局
Mean of Daily Steps on Physical Activity Sensor Logs at 6 months
时间窗: 6 months
This outcome measure will be measured by calculating the average daily steps at end of 6 months. These measures will be collected from sensor logs within the apps for both IG and CG.
Mean of Daily Steps on Physical Activity Sensor Logs at 3 months
时间窗: 3 months
This outcome measure will be measured by calculating the average daily steps at end of 3 months. These measures will be collected from sensor logs within the apps for both IG and CG.
次要结局
- Number of Cardiac Hospitalizations in the past month at 6 months(Baseline, 6 months)
- Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.(Baseline, 3 months)
- Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.(Baseline, 3 months)
- Change from baseline in mean Blood Pressure Control at 3 months(Baseline, 3 months)
- Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.(Baseline, 6 months)
- Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 3 months(Baseline, 3 months)
- Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.(Baseline, 6 months)
- Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 6 months(Baseline, 6 months)
- Change From Baseline in Hypertension self-efficacy as measured by the hypertension self-efficacy subscale of the High Blood Pressure Hypertension Self-Care Profile at 6 months(Baseline, 6 months)
- Change from baseline in mean Blood Pressure Control at 6 months(Baseline, 6 months)
- Change From Baseline in Hypertension self-efficacy as measured by the hypertension self-efficacy subscale of the High Blood Pressure Hypertension Self-Care Profile at 3 months(Baseline, 3 months)
- Change From Baseline in Hypertension self-care behaviors as measured by the hypertension behavior subscale of the High Blood Pressure Hypertension Self-Care Profile (HBP-SCP) at 6 months(Baseline, 6 months)
- Change From Baseline in Hypertension self-care behaviors as measured by the hypertension behavior subscale of the High Blood Pressure Hypertension Self-Care Profile (HBP-SCP) at 3 months(Baseline, 3 months)
- Change from Baseline in Quality of Life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 at 3 months(Baseline, 3 months)
- Change from Baseline in Quality of Life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 at 6 months(Baseline, 6 months)
- Number of Cardiac Hospitalizations in the past month at 3 months(Baseline, 3 months)
研究者
Kavita Radhakrishnan
Principal Investigator
University of Texas at Austin