NCT03947983

Sensor-controlled Digital Game for Heart Failure Self-management

Completed NA Results posted Last updated 28 June 2021

What this trial tests

NA trial testing Sensor-controlled digital game (SCDG) in Heart Failure in 38 participants. Completed in 30 January 2021.

Timeline

12 November 2019

Primary endpoint
10 November 2020

30 January 2021

Quick facts

Lead sponsor	University of Texas at Austin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	38
Start date	12 November 2019
Primary completion	10 November 2020
Estimated completion	30 January 2021
Sites	2 locations across United States

Drugs / interventions tested

• Sensor-controlled digital game (SCDG)
• Sensor Only

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

University of Texas at Austin

Who can join

55 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks Primary · 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).

Group	Value	95% CI
Intervention Group	35.8	± 6.0
Control Group	32.9	± 10.5

Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks Primary · 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).

Group	Value	95% CI
Intervention Group	69.7	± 16.1
Control Group	60.1	± 18.7

Number of Days With Physical Activity on Sensor Logs at 6 Weeks Secondary · 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.

Group	Value	95% CI
Intervention Group	36.7	± 10.9
Control Group	39.2	± 6.6

Number of Days With Physical Activity on Sensor Logs at 12 Weeks Secondary · 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.

Group	Value	95% CI
Intervention Group	76.6	± 11.02
Control Group	69.6	± 17.3

Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks Secondary · 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.

Group	Value	95% CI
Intervention Group	2742	± 2499
Control Group	2638	± 1573

Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks Secondary · 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.

Group	Value	95% CI
Intervention Group	2887	± 2821
Control Group	2541	± 1604

Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 6 Weeks Secondary · Baseline, 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

Group	Value	95% CI
Intervention Group	4.9	± 20.4
Control Group	-2.7	± 9.9

Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 12 Weeks Secondary · Baseline, 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

Group	Value	95% CI
Intervention Group	9.3	± 16.5
Control Group	2.6	± 12.4

Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 24 Weeks Secondary · Baseline, 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

Group	Value	95% CI
Intervention Group	10.2	± 13.4
Control Group	0.5	± 9.8

Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks Secondary · Baseline, 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.

Group	Value	95% CI
Intervention Group	5.8	± 13.1
Control Group	8.7	± 15.3

Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks Secondary · Baseline, 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.

Group	Value	95% CI
Intervention Group	8.2	± 13.5
Control Group	13.0	± 19.3

Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks Secondary · Baseline, 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.

Group	Value	95% CI
Intervention Group	10.8	± 16.9
Control Group	15.4	± 19.6

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. mHealth education interventions in heart failure.
   Allida S, Du H, Xu X, Prichard R, et al · · 2020 · cited 47× · PMID 32613635 · DOI 10.1002/14651858.cd011845.pub2
2. Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial.
   Radhakrishnan K, Julien C, Baranowski T, O'Hair M, et al · · 2021 · cited 17× · PMID 34747701 · DOI 10.2196/29044