HypertensionN-SCDGNCT05671406
RCT of Sensor-controlled Digital Game for Hypertension Self-care in a Native American Community
A study testing Sensor only in people with Hypertension, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Sensor only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Jada Brooks, PhD, 919-966-9511, jada@email.unc.edu
Gail Currin
About this study
Official title: A Sensor-controlled Digital Game-based Approach to Improve Self-care Behaviors Among Adults Diagnosed With Hypertension in a Native American Community
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Sensor-controlled digital game, Sensor only
- Keywords
- hypertension, self-care, digital game, Native American
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-controlled digital gameBehavioural
Also called SCDG
The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid hospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal Hypertension 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 to motivate engagement in and generate habit formation of heart failure related self-management behaviors.
Sensor onlyBehavioural
Real-time behaviors of physical activity will be tracked by an off-the-shelf sensor and app (Withings). This group will also be provided with standardized evidence-based Hypertension educational material. However, the data from the Withings sensor will not be routed to the SCDG.
| Study group | Role | What they receive |
|---|---|---|
| Sensor-controlled digital game | Experimental | The intervention group will receive a sensor-controlled digital game (SCDG) app and physical activity tracker. Receives: Behavioral: Sensor-controlled digital game |
| Sensor-only | Active comparator | The control group will receive only the physical activity tracker. Receives: Behavioral: Sensor only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of Daily Steps on Physical Activity Sensor Logs at 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.
Measured: 3 months
Mean of Daily Steps on Physical Activity Sensor Logs at 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.
Measured: 6 months
Secondary outcomes (16)
Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.
Systolic blood Pressure (SBP) of participants will be measured at baseline using a FDA approved digital sphygmomanometer (A\&D UA-767). The A\&D UA-767 is a fully automated device based on the oscillometric method and has been validated against a mercury sphygmomanometer. Participants will be instructed to refrain from using tobacco products, alcohol, or caffeine for 30 minutes before measurement. Participants will sit quietly, resting the left arm on a flat surface (at the heart's level) for at least 5 minutes before the first measurement. Three measurements will be taken at 1-minute intervals; the second and third readings recorded in mmHg will be averaged to obtain the mean SBP.
Measured: Baseline, 3 months
Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.
Systolic blood Pressure (SBP) of participants will be measured at baseline using a FDA approved digital sphygmomanometer (A\&D UA-767). The A\&D UA-767 is a fully automated device based on the oscillometric method and has been validated against a mercury sphygmomanometer. Participants will be instructed to refrain from using tobacco products, alcohol, or caffeine for 30 minutes before measurement. Participants will sit quietly, resting the left arm on a flat surface (at the heart's level) for at least 5 minutes before the first measurement. Three measurements will be taken at 1-minute intervals; the second and third readings recorded in mmHg will be averaged to obtain the mean SBP.
Measured: Baseline, 6 months
Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.
Diastolic blood Pressure (DBP) of participants will be measured at baseline using a FDA approved digital sphygmomanometer (A\&D UA-767). The A\&D UA-767 is a fully automated device based on the oscillometric method and has been validated against a mercury sphygmomanometer. Participants will be instructed to refrain from using tobacco products, alcohol, or caffeine for 30 minutes before measurement. Participants will sit quietly, resting the left arm on a flat surface (at the heart's level) for at least 5 minutes before the first measurement. Three measurements will be taken at 1-minute intervals; the second and third readings recorded in mmHg will be averaged to obtain the mean DBP.
Measured: Baseline, 3 months
Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.
Diastolic blood Pressure (DBP) of participants will be measured at baseline using a FDA approved digital sphygmomanometer (A\&D UA-767). The A\&D UA-767 is a fully automated device based on the oscillometric method and has been validated against a mercury sphygmomanometer. Participants will be instructed to refrain from using tobacco products, alcohol, or caffeine for 30 minutes before measurement. Participants will sit quietly, resting the left arm on a flat surface (at the heart's level) for at least 5 minutes before the first measurement. Three measurements will be taken at 1-minute intervals; the second and third readings recorded in mmHg will be averaged to obtain the mean DBP.
Measured: Baseline, 6 months
Change from baseline in mean Blood Pressure Control at 3 months
Blood Pressure will be measured as described above for Systolic and Diastolic blood pressure. Blood Pressure Control will be defined as yes if mean SBP < 140 mmHG and mean DBP < 90 mmHG.
Measured: Baseline, 3 months
Change from baseline in mean Blood Pressure Control at 6 months
Blood Pressure will be measured as described above for Systolic and Diastolic blood pressure. Blood Pressure Control will be defined as yes if mean SBP < 140 mmHG and mean DBP < 90 mmHG.
Measured: Baseline, 6 months
Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 3 months
Knowledge will be measured by the Hypertension Knowledge-Level Scale (HK-LS). The scale has 22 items with six sub-dimensions of definition, medical treatment, drug compliance, lifestyle, diet, and complications, respectively. Each correct answer is worth 1 point. The maximum scale score is 22, being scored only when the respondent provides the right answer. Higher scores indicate higher knowledge.
Measured: Baseline, 3 months
Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 6 months
Knowledge will be measured by the Hypertension Knowledge-Level Scale (HK-LS). The scale has 22 items with six sub-dimensions of definition, medical treatment, drug compliance, lifestyle, diet, and complications, respectively. Each correct answer is worth 1 point. The maximum scale score is 22, being scored only when the respondent provides the right answer. Higher scores indicate higher knowledge.
Measured: 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
The hypertension self-efficacy subscale of the High Blood Pressure Hypertension Self-Care Profile has 20 items. Items in this subscale include a 4-point scale format asking how confident are individuals in performing certain behaviors necessary to manage HTN (e.g., physical activity, nutrition). Responses were rated from 1 (not relevant) to 4 (very relevant). Scores are summed with higher scores indicating higher self-efficacy in managing HTN. Scores can range from 20 to 80.
Measured: Baseline, 3 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
The hypertension self-efficacy subscale of the High Blood Pressure Hypertension Self-Care Profile has 20 items. Items in this subscale include a 4-point scale format asking how confident are individuals in performing certain behaviors necessary to manage HTN (e.g., physical activity, nutrition). Responses were rated from 1 (not relevant) to 4 (very relevant). Scores are summed with higher scores indicating higher self-efficacy in managing HTN. Scores can range from 20 to 80.
Measured: 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
The hypertension behavior subscale of the High Blood Pressure Hypertension Self-Care Profile (HBP-SCP) has 20 items. Items in this subscale include a 4-point scale format asking how often individuals performed certain behaviors necessary to manage HTN (e.g., physical activity, nutrition). Responses were rated from 1 (not relevant) to 4 (very relevant). Scores were summed with higher scores indicating more positive self-care behaviors in managing hypertension. Scores can range from 20 to 80.
Measured: 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
The hypertension behavior subscale of the High Blood Pressure Hypertension Self-Care Profile (HBP-SCP) has 20 items. Items in this subscale include a 4-point scale format asking how often individuals performed certain behaviors necessary to manage HTN (e.g., physical activity, nutrition). Responses were rated from 1 (not relevant) to 4 (very relevant). Scores were summed with higher scores indicating more positive self-care behaviors in managing hypertension. Scores can range from 20 to 80.
Measured: Baseline, 6 months
Change from Baseline in Quality of Life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 at 3 months
The PROMIS Global-10 is a 10-item questionnaire that assesses the general quality of life (QOL) divided into two domains-physical and mental health. Each domain's scores are derived using T-score normal population distribution mean ± standard deviation (SD) of 50 ± 10, where higher scores indicate better health.
Measured: 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
The PROMIS Global-10 is a 10-item questionnaire that assesses the general quality of life (QOL) divided into two domains-physical and mental health. Each domain's scores are derived using T-score normal population distribution mean ± standard deviation (SD) of 50 ± 10, where higher scores indicate better health.
Measured: Baseline, 6 months
Number of Cardiac Hospitalizations in the past month at 3 months
This measure will be obtained through participant self-report through periodic online surveys and will be confirmed by hospital discharge summary provided by the participant.
Measured: Baseline, 3 months
Number of Cardiac Hospitalizations in the past month at 6 months
This measure will be obtained through participant self-report through periodic online surveys and will be confirmed by hospital discharge summary provided by the participant.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start27 Jun 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kavita Radhakrishnan, University of Texas at Austin
- Investigators
- Kavita Radhakrishnan, Phd, Principal investigator, The University of Texas Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671406
- Sponsor's protocol ID
- R01HL162598
- Other IDs
- STUDY00002092, R01HL162598
- Acronym
- N-SCDG
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. After review of the purpose of the data request to make sure it is consistent with the original project goals and verification that the request meets IRB approval, de-identified data may be shared with researchers as soon as possible but no later than within one year from the completion of the funded project period for the parent award or upon acceptance of the data for publication, whichever is earlier.
Publications
Radhakrishnan K, Im CR, Brooks JL, Fallon GC, Rangel A, Julien C, O'Hair M, Liang H, Lowe J. Sensor-controlled digital game for Native American adults in the Lumbee Tribe with hypertension self-management: study protocol for a randomized controlled trial. Trials. 2025 Sep 1;26(1):329. doi: 10.1186/s13063-025-09026-y.
PubMed 40890750
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sensor-controlled Digital Game-based Approach to Improve Self-care Behaviors Among Adults Diagnosed With Hypertension in a Native American Community
- ClinicalTrials.gov ID
- NCT05671406
- Acronym / sponsor ID
- N-SCDG / R01HL162598
- Conditions
- Hypertension
- Keywords
- hypertension, self-care, digital game, Native American
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensor-controlled digital game | Experimental | Behavioral: Sensor-controlled digital gameThe intervention group will receive a sensor-controlled digital game (SCDG) app and physical activity tracker. |
| Sensor-only | Active comparator | Behavioral: Sensor onlyThe control group will receive only the physical activity tracker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensor-controlled digital gameAlso: SCDGThe SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid hospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal Hypertension 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 to motivate engagement in and generate habit formation of heart failure related self-management behaviors. | Behavioural | Sensor-controlled digital game |
| Sensor onlyReal-time behaviors of physical activity will be tracked by an off-the-shelf sensor and app (Withings). This group will also be provided with standardized evidence-based Hypertension educational material. However, the data from the Withings sensor will not be routed to the SCDG. | Behavioural | Sensor-only |
Primary outcome
Mean of Daily Steps on Physical Activity Sensor Logs at 3 months
Time frame: 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.
Mean of Daily Steps on Physical Activity Sensor Logs at 6 months
Time frame: 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.
16 secondary outcomes
Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.
Time frame: Baseline, 3 months
Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.
Time frame: Baseline, 6 months
Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.
Time frame: Baseline, 3 months
Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.
Time frame: Baseline, 6 months
Change from baseline in mean Blood Pressure Control at 3 months
Time frame: Baseline, 3 months
Change from baseline in mean Blood Pressure Control at 6 months
Time frame: Baseline, 6 months
Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 3 months
Time frame: Baseline, 3 months
Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 6 months
Time frame: 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
Time frame: Baseline, 3 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 6 months
Change from Baseline in Quality of Life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 at 3 months
Time frame: 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
Time frame: Baseline, 6 months
Number of Cardiac Hospitalizations in the past month at 3 months
Time frame: Baseline, 3 months
Number of Cardiac Hospitalizations in the past month at 6 months
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 40890750Radhakrishnan K, Im CR, Brooks JL, Fallon GC, Rangel A, Julien C, O'Hair M, Liang H, Lowe J. Sensor-controlled digital game for Native American adults in the Lumbee Tribe with hypertension self-management: study protocol for a randomized controlled trial. Trials. 2025 Sep 1;26(1):329. doi: 10.1186/s13063-025-09026-y.
- Individual participant dataSharing planned: Undecided. The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. After review of the purpose of the data request to make sure it is consistent with the original project goals and verification that the request meets IRB approval, de-identified data may be shared with researchers as soon as possible but no later than within one year from the completion of the funded project period for the parent award or upon acceptance of the data for publication, whichever is earlier.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kavita Radhakrishnan, Phd principal investigator
The University of Texas Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor only in people with Hypertension, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jada Brooks, PhD (919-966-9511, jada@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of Daily Steps on Physical Activity Sensor Logs at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.