Heart Failure Clinical Trial
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
Verified date | June 2021 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | January 30, 2021 |
Est. primary completion date | November 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
United States | Cardiac Floor, Seton Medical Center Austin | Austin | Texas |
United States | Cardiac Rehabilitation Center, Seton Medical Center Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin | National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 6 weeks | |
Primary | 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). | 12 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 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 | Baseline, 6 weeks | |
Secondary | 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 | Baseline, 12 weeks | |
Secondary | 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 | Baseline, 24 weeks | |
Secondary | 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. | Baseline, 6 weeks | |
Secondary | 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. | Baseline, 12 weeks | |
Secondary | 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. | Baseline, 24 weeks | |
Secondary | 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. | Baseline, 6 weeks | |
Secondary | 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. | Baseline, 12 weeks | |
Secondary | 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. | Baseline, 24 weeks | |
Secondary | 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 | Baseline, 24 weeks | |
Secondary | 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 | Baseline, 12 weeks | |
Secondary | 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 | Baseline, 6 weeks | |
Secondary | 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 | Baseline, 24 weeks | |
Secondary | 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 | Baseline, 6 weeks | |
Secondary | 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 | Baseline, 12 weeks | |
Secondary | 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 | Baseline,24 weeks | |
Secondary | 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. | Baseline, 24 weeks | |
Secondary | 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. | Baseline, 12 weeks | |
Secondary | 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. | Baseline, 6 weeks | |
Secondary | 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. |
Baseline, 6 weeks | |
Secondary | 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. |
Baseline, 12 weeks | |
Secondary | 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. |
Baseline, 24 weeks |
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