N/A
Completed N=38
Sensor-controlled Digital Game for Heart Failure Self-management
Source: ClinicalTrials.gov NCT03947983 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks — 35.8; 32.9 days
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). 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks |
35.8; 32.9 | — |
| PRIMARY Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks |
69.7; 60.1 | — |
| SECONDARY Number of Days With Physical Activity on Sensor Logs at 6 Weeks |
36.7; 39.2 | — |
| SECONDARY Number of Days With Physical Activity on Sensor Logs at 12 Weeks |
76.6; 69.6 | — |
| SECONDARY Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks |
2742; 2638 | — |
| SECONDARY Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks |
2887; 2541 | — |
| SECONDARY Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 6 Weeks |
4.9; -2.7 | — |
| SECONDARY Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 12 Weeks |
9.3; 2.6 | — |
| SECONDARY Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 24 Weeks |
10.2; 0.5 | — |
| SECONDARY Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks |
5.8; 8.7 | — |
| SECONDARY Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks |
8.2; 13.0 | — |
| SECONDARY Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks |
10.8; 15.4 | — |
| SECONDARY Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks |
6.9; 1.7 | — |
| SECONDARY Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks |
3.7; 4.1 | — |
| SECONDARY Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks |
7.4; 6.5 | — |
| SECONDARY Number of Heart Failure Hospitalizations in the Past 6 Months at End of 24 Weeks as Assessed by Self-report |
2; 2 | — |
| SECONDARY Number of Heart Failure Hospitalizations in the Past Month at End of 12 Weeks as Assessed by Self-report |
0; 1 | — |
| SECONDARY Number of Heart Failure Hospitalizations in the Past Month at End of 6 Weeks as Assessed by Self-report |
1; 1 | — |
| SECONDARY Number of Heart Failure Hospitalizations in the Past Month at End of 24 Weeks as Assessed by Self-report |
1; 0 | — |
| SECONDARY Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 6 Weeks |
1.9; 2.1 | — |
| SECONDARY Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 12 Weeks |
1.4; 1.1 | — |
| SECONDARY Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 24 Weeks |
1.1; 1.1 | — |
| SECONDARY Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 24 Weeks |
3.0; 7.0 | — |
| SECONDARY Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks |
1.0; 10.2 | — |
| SECONDARY Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 6 Weeks |
2.2; 6.9 | — |
| SECONDARY Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 6 Weeks |
-0.1; -0.2 | — |
| SECONDARY Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 12 Weeks |
0.1; -0.3 | — |
| SECONDARY Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 24 Weeks |
-0.6; -0.2 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03947983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.