Heart FailureNCT03947983
Sensor-controlled Digital Game for Heart Failure Self-management
A study testing Sensor Only in people with Heart Failure, run by University of Texas at Austin at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Heart Failure
- 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
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Nov 2019to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cardiac Floor, Seton Medical Center Austin
Austin, Texas, 78705
Cardiac Rehabilitation Center, Seton Medical Center Austin
Austin, Texas, 78705
About this study
Official title: A Pilot Sensor-controlled Digital Gaming Intervention With Real-time Behavior Tracking to Motivate Self-management Behaviors in Older Adults With Heart Failure
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- Sensor-controlled digital game (SCDG), Sensor Only
- Keywords
- self-management, digital game, sensor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-controlled digital game (SCDG)Behavioural
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.
Sensor OnlyBehavioural
Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Receives: Behavioral: Sensor-controlled digital game (SCDG) |
| Control group | Active comparator | The control group will receive only the weight monitoring and physical activity sensors Receives: Behavioral: Sensor Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days With Weight-monitoring on Sensor Logs at 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).
Measured: 6 weeks
Number of Days With Weight-monitoring on Sensor Logs at 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).
Measured: 12 weeks
Secondary outcomes (26)
Number of Days With Physical Activity on Sensor Logs at 6 Weeks
This outcome measure will be measured by collecting number of days with physical activity data. These measures will be collected from sensor logs within the apps for both IG and CG.
Measured: 6 weeks
Number of Days With Physical Activity on Sensor Logs at 12 Weeks
This outcome measure will be measured by collecting number of days with physical activity data. These measures will be collected from sensor logs within the apps for both IG and CG.
Measured: 12 weeks
Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks
This outcome measure will be measured by calculating the average daily steps at end of 6 weeks. These measures will be collected from sensor logs within the apps for both IG and CG.
Measured: 6 weeks
Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks
This outcome measure will be measured by calculating the average daily steps at end of 12 weeks. These measures will be collected from sensor logs within the apps for both IG and CG.
Measured: 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
The instrument used will be 9-item European Heart Failure Self-care Behavior Scale (HSBS; standardized score from 0 to 100 (every item is given an equal weight) with a higher score meaning better self-care). Items are on a Likert scale of 1 - 5. For calculating the standardized score, each item is reverse coded and then computed using the formula: (Sum of all ever-coded items - 9)*2.7777
Measured: 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
The instrument used will be 9-item European Heart Failure Self-care Behavior Scale (HSBS; standardized score from 0 to 100 (every item is given an equal weight) with a higher score meaning better self-care. Items are on a Likert scale of 1 - 5. For calculating the standardized score, each item is reverse coded and then computed using the formula: (Sum of all ever-coded items - 9)*2.7777
Measured: Baseline, 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
The instrument used will be 9-item European Heart Failure Self-care Behavior Scale (HSBS; standardized score from 0 to 100 (every item is given an equal weight) with a higher score meaning better self-care). Items are on a Likert scale of 1 - 5. For calculating the standardized score, each item is reverse coded and then computed using the formula: (Sum of all ever-coded items - 9)*2.7777
Measured: Baseline, 24 weeks
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks
The instrument used will be items 13 - 15 on the KCCQ. Values for the QoL domain range from 0 to 100 with higher scores indicating better quality of life. Domain score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: Baseline, 6 weeks
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks
The instrument used will be items 13 - 15 on the KCCQ. Values for the QoL domain range from 0 to 100 with higher scores indicating better quality of life. Domain score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: Baseline, 12 weeks
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks
The instrument used will be items 13 - 15 on the KCCQ. Values for the QoL domain range from 0 to 100 with higher scores indicating better quality of life. Domain score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: Baseline, 24 weeks
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks
The instrument used will be items 1-12 on the KCCQ. Values for the functional status summary score from 0 to 100 with higher scores indicating better quality of life. Summary score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: Baseline, 6 weeks
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks
The instrument used will be items 1-12 on the KCCQ. Values for the functional status summary score from 0 to 100 with higher scores indicating better quality of life. Summary score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: Baseline, 12 weeks
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks
The instrument used will be items 1-12 on the KCCQ. Values for the functional status summary score from 0 to 100 with higher scores indicating better quality of life. Summary score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Measured: Baseline, 24 weeks
Number of Heart Failure Hospitalizations in the Past 6 Months at End of 24 Weeks as Assessed by Self-report
This measure of number of cardiac hospitalizations in the past 6 months was obtained through participant self-report
Measured: Baseline, 24 weeks
Number of Heart Failure Hospitalizations in the Past Month at End of 12 Weeks as Assessed by Self-report
This measure will be obtained through participant self-report
Measured: Baseline, 12 weeks
Number of Heart Failure Hospitalizations in the Past Month at End of 6 Weeks as Assessed by Self-report
This measure will be obtained through participant self-report
Measured: Baseline, 6 weeks
Number of Heart Failure Hospitalizations in the Past Month at End of 24 Weeks as Assessed by Self-report
This measure will be obtained through participant self-report
Measured: Baseline, 24 weeks
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 6 Weeks
The instrument used will be 30-item Atlanta Heart Failure Knowledge Test (AHFKT). Each correct answer is scored as 1 point, with no additional weighting of items; correct responses are then summed. Incorrect or skipped questions are awarded 0 points. Total scores range from 0 to 30. Higher scores indicate better HF knowledge
Measured: Baseline, 6 weeks
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 12 Weeks
The instrument used will be 30-item Atlanta Heart Failure Knowledge Test (AHFKT). Each correct answer is scored as 1 point, with no additional weighting of items; correct responses are then summed. Incorrect or skipped questions are awarded 0 points. Total scores range from 0 to 30. Higher scores indicate better HF knowledge
Measured: Baseline, 12 weeks
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 24 Weeks
The instrument used will be 30-item Atlanta Heart Failure Knowledge Test (AHFKT). Each correct answer is scored as 1 point, with no additional weighting of items; correct responses are then summed. Incorrect or skipped questions are awarded 0 points. Total scores range from 0 to 30. Higher scores indicate better HF knowledge
Measured: Baseline,24 weeks
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 24 Weeks
The instrument used will be 6-item Section C Self-efficacy section of Self-care of heart failure Index (SCHFI). Scores on the self-efficacy scale will range from 0 to 100, with higher scores reflecting better self-efficacy. To standardize scores the formula: (sum of Section C items - 6) * 5.56 will be used.
Measured: Baseline, 24 weeks
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks
The instrument used will be 6-item Section C Self-efficacy section of Self-care of heart failure Index (SCHFI). Scores on the self-efficacy scale will range from 0 to 100, with higher scores reflecting better self-efficacy. To standardize scores the formula: (sum of Section C items - 6) * 5.56 will be used.
Measured: Baseline, 12 weeks
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 6 Weeks
The instrument used will be 6-item Section C Self-efficacy section of Self-care of heart failure Index (SCHFI). Scores on the self-efficacy scale will range from 0 to 100, with higher scores reflecting better self-efficacy. To standardize scores the formula: (sum of Section C items - 6) * 5.56 will be used.
Measured: Baseline, 6 weeks
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 6 Weeks
In the 19-item Treatment Self-Regulation Questionnaire (TSRQ) adapted for heart failure, each item can receive a value ranging from 1 - 7, as selected by the participant. The scale has 2 sub-scales: autonomous and controlled motivation. Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are:
Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19. Scores for Autonomous Regulation can range from 8 to 56. High scores indicate high autonomous motivation or intrinsic motivation for behavior engagement.
Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Scores for Controlled Regulation can range from 8 to 56. High scores indicate high controlled motivation or extrinsic motivation for behavior engagement.
Scoring for RAI will consist of subtracting the average for Controlled Regulation from the average for Autonomous Regulation. Higher RAI scores indicate higher autonomous or intrinsic motivation for behavior engagement.
Measured: Baseline, 6 weeks
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 12 Weeks
In the 19-item Treatment Self-Regulation Questionnaire (TSRQ) adapted for heart failure, each item can receive a value ranging from 1 - 7, as selected by the participant. The scale has 2 sub-scales: autonomous and controlled motivation. Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are:
Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19. Scores for Autonomous Regulation can range from 8 to 56. High scores indicate high autonomous motivation or intrinsic motivation for behavior engagement.
Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Scores for Controlled Regulation can range from 8 to 56. High scores indicate high controlled motivation or extrinsic motivation for behavior engagement.
Scoring for RAI will consist of subtracting the average for Controlled Regulation from the average for Autonomous Regulation. Higher RAI scores indicate higher autonomous or intrinsic motivation for behavior engagement.
Measured: Baseline, 12 weeks
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 24 Weeks
In the 19-item Treatment Self-Regulation Questionnaire (TSRQ) adapted for heart failure, each item can receive a value ranging from 1 - 7, as selected by the participant. The scale has 2 sub-scales: autonomous and controlled motivation. Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are:
Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19. Scores for Autonomous Regulation can range from 8 to 56. High scores indicate high autonomous motivation or intrinsic motivation for behavior engagement.
Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Scores for Controlled Regulation can range from 8 to 56. High scores indicate high controlled motivation or extrinsic motivation for behavior engagement.
Scoring for RAI will consist of subtracting the average for Controlled Regulation from the average for Autonomous Regulation. Higher RAI scores indicate higher autonomous or intrinsic motivation for behavior engagement.
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start12 Nov 2019
- Primary completion10 Nov 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two arms of intervention group or control group. The control group will receive only the weight monitoring and physical activity sensors while the intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- 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
- NCT03947983
- Sponsor's protocol ID
- 201800216-001
- Other IDs
- R21NR018229
- Status last verified
- Jun 2021
- First submitted
- 8 May 2019
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Sensor-controlled Digital Gaming Intervention With Real-time Behavior Tracking to Motivate Self-management Behaviors in Older Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT03947983
- Acronym / sponsor ID
- 201800216-001
- Conditions
- Heart Failure
- Keywords
- self-management, digital game, sensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Posted 28 Jun 2021
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 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two arms of intervention group or control group. The control group will receive only the weight monitoring and physical activity sensors while the intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Sensor-controlled digital game (SCDG)The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors |
| Control group | Active comparator | Behavioral: Sensor OnlyThe control group will receive only the weight monitoring and physical activity sensors |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
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 game (SCDG)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. | Behavioural | Intervention Group |
| Sensor OnlyReal-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG. | Behavioural | Control group |
Primary outcome
Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks
Time frame: 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
Time frame: 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).
26 secondary outcomes
Number of Days With Physical Activity on Sensor Logs at 6 Weeks
Time frame: 6 weeks
Number of Days With Physical Activity on Sensor Logs at 12 Weeks
Time frame: 12 weeks
Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks
Time frame: 6 weeks
Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks
Time frame: 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
Time frame: 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
Time frame: Baseline, 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
Time frame: Baseline, 24 weeks
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks
Time frame: Baseline, 6 weeks
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks
Time frame: Baseline, 24 weeks
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks
Time frame: Baseline, 6 weeks
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks
Time frame: Baseline, 24 weeks
Number of Heart Failure Hospitalizations in the Past 6 Months at End of 24 Weeks as Assessed by Self-report
Time frame: Baseline, 24 weeks
Number of Heart Failure Hospitalizations in the Past Month at End of 12 Weeks as Assessed by Self-report
Time frame: Baseline, 12 weeks
Number of Heart Failure Hospitalizations in the Past Month at End of 6 Weeks as Assessed by Self-report
Time frame: Baseline, 6 weeks
Number of Heart Failure Hospitalizations in the Past Month at End of 24 Weeks as Assessed by Self-report
Time frame: Baseline, 24 weeks
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 6 Weeks
Time frame: Baseline, 6 weeks
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 24 Weeks
Time frame: Baseline,24 weeks
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 24 Weeks
Time frame: Baseline, 24 weeks
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 6 Weeks
Time frame: Baseline, 6 weeks
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 6 Weeks
Time frame: Baseline, 6 weeks
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 24 Weeks
Time frame: Baseline, 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34747701Radhakrishnan 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.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
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. This study is not recruiting at the moment.
Kavita Radhakrishnan, PhD principal investigator
The University of Texas Austin
2 sites 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 Heart Failure, run by University of Texas at Austin at 2 sites 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 28 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks (time frame: 6 weeks). 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 NCT03947983, 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 28 Jun 2021.