N/A N=38 Randomized Double-blind Supportive Care

Sensor-controlled Digital Game for Heart Failure Self-management

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03947983 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks — 35.8; 32.9 days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sensor-controlled digital game (SCDG) (Behavioral); Sensor Only (Behavioral)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: University of Texas at Austin
Primary completion: Nov 2020

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	—

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.

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).

View full record on ClinicalTrials.gov →

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.