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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
SCDG Trial 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.Check my eligibility
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.See study design
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.
SCDG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk on my own without needing a cane or walker.
Select...
I am 45 years old or older.
Select...
I was hospitalized for heart failure in the last year.
Select...
My heart condition allows me to do some physical activity without discomfort.
Select...
I passed a short test checking my thinking skills.
SCDG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreSCDG 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
353 Previous Clinical Trials
81,044 Total Patients Enrolled
1 Trials studying Heart Failure
38 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,848 Total Patients Enrolled
206 Trials studying Heart Failure
677,248 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your vision or ability to touch things is severely impaired, making it difficult for you to use a smartphone or sensor devices.I can walk on my own without needing a cane or walker.I have had kidney failure that worsens my heart failure prognosis.I am 45 years old or older.I have been diagnosed with a terminal illness.You have had a heart transplant or have a special device to help your heart pump blood.I was hospitalized for heart failure in the last year.My heart condition allows me to do some physical activity without discomfort.I passed a short test checking my thinking skills.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sensor-controlled digital game (SCDG)
- Group 2: Sensors-only
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many human participants are partaking in this medical experiment?
"Indeed, the figures posted on clinicaltrials.gov confirm that this study is currently enrolling participants and requires 200 people to join from a single medical centre. The trial was first advertised on September 22nd 2022 and has been recently updated as of December 1st 2022."
Answered by AI
What objective is this clinical trial hoping to achieve?
"This study, which will be tracked over a period of 12 weeks, seeks to observe the Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks. Additionally, it intends to measure Mean of Daily Steps on Physical Activity Sensor Logs at 6 and 12 Weeks as well as Change From Baseline in Heart failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks from sensor logs gathered within apps for both intervention and control groups."
Answered by AI
Are any fresh participants being welcomed for this experiment?
"Affirmative. According to the details hosted on clinicaltrials.gov, this clinical trial is actively recruiting individuals who meet its criteria; it was first posted on September 22nd 2022 and most recently updated December 1st 2022. 200 subjects are required at one medical center for inclusion in the study."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
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