Sensor-controlled Digital Game for Heart Failure Self-management

NCT03947983 | Completed Results DMC

• 2 other identifiers: 201800216-001R21NR018229
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure

Keywords

self-management; digital game; sensor

Outcome Measures

Primary Outcomes (2)

• Number of Days With Weight-monitoring on Sensor Logs at 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).

  6 weeks

• Number of Days With Weight-monitoring on Sensor Logs at 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).

  12 weeks

Secondary Outcomes (26)

• Number of Days With Physical Activity on Sensor Logs at 6 Weeks

  6 weeks

• Number of Days With Physical Activity on Sensor Logs at 12 Weeks

  12 weeks

• Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks

  6 weeks

• Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks

  12 weeks

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

  Baseline, 6 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors

Behavioral: Sensor-controlled digital game (SCDG)

Control group

ACTIVE COMPARATOR

The control group will receive only the weight monitoring and physical activity sensors

Behavioral: Sensor Only

Interventions

Sensor-controlled digital game (SCDG) BEHAVIORAL

The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid rehospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal HF health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app. The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback (e.g., reduce fluid intake or call doctor for weight gain) to motivate engagement in and generate habit formation of heart failure related self-management behaviors.

Intervention Group

Sensor Only BEHAVIORAL

Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG.

Control group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 years or older
• New York Heart Association (NYHA) heart failure classification of I to III that permits minimal physical activity without discomfort
• Understand 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
• Ownership of a smartphone or digital tablet

You may not qualify if:

• Severe visual (e.g., legally blind) or tactile (e.g., severe arthritis) impairments that adversely prevent the use of a smartphone or sensor devices
• History of renal failure which adversely affects heart failure prognosis
• Diagnosis of an end stage or terminal illness (e.g., cancer).

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Cardiac Floor, Seton Medical Center Austin

Austin, Texas, 78705, United States

Location

Cardiac Rehabilitation Center, Seton Medical Center Austin

Austin, Texas, 78705, United States

Location

Related Publications (1)

• Radhakrishnan K, Julien C, Baranowski T, O'Hair M, Lee G, Sagna De Main A, Allen C, Viswanathan B, Thomaz E, Kim M. Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. JMIR Serious Games. 2021 Nov 8;9(4):e29044. doi: 10.2196/29044.

  PMID: 34747701 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kavita Radhakrishnan
• Organization: The University of Texas Austin

kradhakrishnan@mail.nur.utexas.edu

5124717936

Study Officials

• Kavita Radhakrishnan, PhD

  The University of Texas Austin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized into two arms of intervention group or control group. The control group will receive only the weight monitoring and physical activity sensors while the intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: November 12, 2019
• Primary Completion: November 10, 2020
• Study Completion: January 30, 2021
• Last Updated: June 28, 2021
• Results First Posted: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)