Does Activity Feedback Increase ICD Patient Activity Levels?

Ashley Burch

Status: Completed

Conditions: ICD Patients

Treatments: Behavioral: Fitbit

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03084458

CR3535

Details and patient eligibility

About

Medical device technology for use by patients is gaining popularity. Modern cardiac disease management seeks to integrate multiple device technologies and capabilities to optimize health outcomes. Fitbit, Inc. manufactures a line of wireless-enabled activity, wearable trackers that are used in conjunction with a mobile device. The Fitbit trackers use three-dimensional accelerometers to sense and record movement. This technology represents a new frontier for patients and their health care providers to understand and track physical activity in real time. The primary aim of the current project is to assess whether activity feedback using FitBit technology affects implantable cardioverter defibrillator (ICD) patient activity level as measured by the ICD accelerometer. The investigators will also examine the perceived added value of Fitbit technology to an ICD patient user experience.

Approximately 50 participants will be recruited. Participants in the experimental group (n = 25) will use the Fitbit device for 12 weeks. The experimental group will receive fitness goals (number of steps per day) to increase activity from a baseline value to a minimum of 7000 steps per day by week 9 of the intervention. Both groups will receive weekly texts messages to encourage activity. Feedback about technology satisfaction, cardiac anxiety, cardiac self-care, and health care utilization will be elicited from patients at multiple time points. Additional information will be gained about patient decision-making as participants may elect to continue Fitbit use beyond the study period; this will allow for behavioral evidence of the perceived value of adding this technology.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• has a Medtronic ICD
• access to a smartphone, tablet, or computer with internet access
• English speaking

Exclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Control

No Intervention group

Description:

Once consented, recruited ICD patients will complete the baseline psychosocial and quality of life measures. At the first and final visit, a 6-minute walk test will be administered. Participants will be sent text messages to encourage physical activity. Participants will be re-assessed with psychosocial and quality of life measures at 30 and 90 days post enrollment. At the final (90 day) visit participants ICD will be interrogated to obtain accelerometer activity data.

Fitbit

Experimental group

Description:

Same as control condition. In addition, participants in the experimental group will receive a Fitbit device with full instructions and troubleshooting. These participants will be given daily step goals, which will be increased during the course of the study, and be able to monitor their progress using the Fitbit app.

Treatment:

Behavioral: Fitbit