Sensor-controlled Digital Game for Heart Failure Self-management: A Clinical Trial
This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of weight monitoring and physical activity in 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.
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) 1 November 2022
🗓️ Primary Completion (Estimated) 30 October 2025
✅ Study Completion (Estimated) 28 December 2025
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Austin, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age 45 years or older
    • * New York Heart Association (NYHA) heart failure classification of I to III that permits minimal physical activity without discomfort
    • * have experienced HF hospitalization in the past 12 months
    • * be fluent in 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

    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;
    • * a history of renal failure, which adversely affects HF prognosis
    • * a diagnosis of an end-stage or terminal illness (e.g., cancer)
    • * undergone heart transplantation, or implantation of a durable mechanical circulatory support device (e.g., left ventricular assist device) due to unique self-management needs.
Ages Eligible for Study: 45 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 September 2021
  • First Submitted that Met QC Criteria 17 September 2021
  • First Posted 24 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 October 2023
  • Last Update Posted 23 October 2023
  • Last Verified October 2023