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Digital Game for Heart Failure (SCDG Trial)

N/A
Recruiting
Led By Kavita Radhakrishnan, PhD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age 45 years or older
Must not have
A history of renal failure, which adversely affects HF prognosis
A diagnosis of an end-stage or terminal illness (e.g., cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a digital game can help motivate adults with heart failure to better manage their weight and physical activity.

Who is the study for?
Adults over 45 with heart failure that allows for minimal physical activity, who have been hospitalized for it in the past year. They must speak English, pass a cognitive test, and be able to walk without support. Those with severe visual/tactile impairments, renal failure, terminal illnesses or who've had certain heart procedures are excluded.
What is being tested?
The trial is testing if a sensor-controlled digital game can improve self-management in heart failure patients by encouraging weight monitoring and exercise. Participants are randomly divided into two groups: one uses the game with sensors; the other uses only sensors.
What are the potential side effects?
Since this trial involves non-invasive technology rather than medication, traditional side effects aren't expected. However, participants may experience frustration or stress from using new technology or potential privacy concerns related to data collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk on my own without needing a cane or walker.
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I am 45 years old or older.
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I was hospitalized for heart failure in the last year.
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My heart condition allows me to do some physical activity without discomfort.
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I passed a short test checking my thinking skills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had kidney failure that worsens my heart failure prognosis.
Select...
I have been diagnosed with a terminal illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks
Number of Days With Weight-monitoring on Sensor Logs at 24 Weeks
Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks
Secondary study objectives
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 24 Weeks
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 6 Weeks
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sensor-controlled digital game (SCDG)Experimental Treatment1 Intervention
The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors
Group II: Sensors-onlyActive Control1 Intervention
The control group will receive only the weight monitoring and physical activity sensors
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sensor-controlled digital game (SCDG)
2019
N/A
~40

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
378 Previous Clinical Trials
86,405 Total Patients Enrolled
1 Trials studying Heart Failure
38 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,699 Total Patients Enrolled
209 Trials studying Heart Failure
677,481 Patients Enrolled for Heart Failure
Kavita Radhakrishnan, PhDPrincipal InvestigatorThe University of Texas Austin
1 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Heart Failure
38 Patients Enrolled for Heart Failure

Media Library

Sensor-controlled digital game (SCDG) Clinical Trial Eligibility Overview. Trial Name: NCT05056129 — N/A
Heart Failure Clinical Trial 2023: Sensor-controlled digital game (SCDG) Highlights & Side Effects. Trial Name: NCT05056129 — N/A
Heart Failure Research Study Groups: Sensor-controlled digital game (SCDG), Sensors-only
Sensor-controlled digital game (SCDG) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05056129 — N/A
~57 spots leftby Oct 2025
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