Clinical trial NCT05671406: RCT of Sensor-controlled Digital Game for Hypertension Self-care in a Native American Community
Official title: A Sensor-controlled Digital Game-based Approach to Improve Self-care Behaviors Among Adults Diagnosed With Hypertension in a Native American Community
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
self-care
digital game
Native American
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-01-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean of Daily Steps on Physical Activity Sensor Logs at 3 months
timeFrame: 3 months
measure: Mean of Daily Steps on Physical Activity Sensor Logs at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.
timeFrame: Baseline, 3 months
measure: Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.
timeFrame: Baseline, 6 months
measure: Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.
timeFrame: Baseline, 3 months
measure: Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.
timeFrame: Baseline, 6 months
measure: Change from baseline in mean Blood Pressure Control at 3 months
timeFrame: Baseline, 3 months
measure: Change from baseline in mean Blood Pressure Control at 6 months
timeFrame: Baseline, 6 months
measure: Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 3 months
timeFrame: Baseline, 3 months
measure: Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 6 months
timeFrame: Baseline, 6 months
measure: 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
timeFrame: Baseline, 3 months
measure: 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
timeFrame: Baseline, 6 months
measure: 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
timeFrame: Baseline, 3 months
measure: 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
timeFrame: Baseline, 6 months
measure: Change from Baseline in Quality of Life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 at 3 months
timeFrame: Baseline, 3 months
measure: Change from Baseline in Quality of Life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 at 6 months
timeFrame: Baseline, 6 months
measure: Number of Cardiac Hospitalizations in the past month at 3 months
timeFrame: Baseline, 3 months
measure: Number of Cardiac Hospitalizations in the past month at 6 months
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: The University of Texas Austin
name: Kavita Radhakrishnan, Phd
role: PRINCIPAL_INVESTIGATOR
References: