RECRUITING

Sensor-controlled Digital Game for Heart Failure Self-management: A Clinical Trial

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sensor-controlled Digital Game for Heart Failure Selfmanagement Behavior Adherence: A Randomized Controlled Trial

Quick Facts

Study Start:2022-11-01

Study Completion:2025-12-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05056129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Angelica Rangel, MS

CONTACT

512-956-8714

arangel@nursing.utexas.edu

Principal Investigator

Kavita Radhakrishnan, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas Austin

Study Locations (Sites)

The University of Texas Austin

Austin, Texas, 78701

United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

Kavita Radhakrishnan, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Austin

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

Study Start Date2022-11-01

Study Completion Date2025-12-28

Study Record Updates

Study Start Date2022-11-01

Study Completion Date2025-12-28

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure