Sensor-controlled Digital Game for Heart Failure Self-management

NCT ID: NCT03947983

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-12
• Study Completion Date: 2021-01-30

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.

Detailed Description

The primary goal of this study is to obtain initial efficacy data and undertake a comprehensive feasibility assessment of a SCDG intervention that synchronizes with a Bluetooth-enabled weight scale and activity tracker to activate game rewards and feedback based on older adult heart failure (HF) participants' real-time weight monitoring and exercise behaviors.

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. The goal of this proposal is to demonstrate the feasibility of the SCDG concept with an optimal number of sensors in a small study so as to lay a foundation for scaling this concept to include more relevant sensors in longer, larger studies.

In this study, the initial efficacy of the SCDG intervention for primary outcome of rate of engagement in HF self-management behavior of weight-monitoring and secondary outcomes of physical activity engagement, HF self-management-knowledge, and self-efficacy, HF-functional status, hospitalization, cognitive ability, depression and quality of life will be evaluated. For this study, 44 older adults diagnosed with the New York Heart Association's HF classification I to III from out-patient HF settings in central Texas will be recruited, and randomized to either the SCDG intervention group that will receive sensors tracking weight monitoring and activity and play the SCDG on a mobile smartphone for 12 weeks or a control group that will receive sensors and an app tracking activity and weight monitoring, and standardized written HF educational modules.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Sensor-controlled digital game (SCDG)

Intervention Type: 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.

Control group

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

Group Type: ACTIVE_COMPARATOR

Sensor Only

Intervention Type: 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.

Interventions

Sensor-controlled digital game (SCDG)

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 Type: BEHAVIORAL

Sensor Only

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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
• History of renal failure which adversely affects heart failure prognosis
• Diagnosis of an end stage or terminal illness (e.g., cancer).

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Kavita Radhakrishnan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kavita Radhakrishnan, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Austin

Locations

Cardiac Floor, Seton Medical Center Austin

Austin, Texas, United States

Cardiac Rehabilitation Center, Seton Medical Center Austin

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34747701 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R21NR018229

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201800216-001

Identifier Type: -

Identifier Source: org_study_id