Clinical trial NCT03084458: Does Activity Feedback Increase ICD Patient Activity Levels?
Official title: Does Activity Feedback Increase ICD Patient Activity Levels?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICD Patients
Keywords: Increasing daily physical activity
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: Medtronic
name: University of North Carolina, Chapel Hill
First posted: 2017-03-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, between subjects design will allow for comparisons between the experimental and control groups.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Does increased access to information on daily activity level (FitBit) increase device (ICD) coded total activity (step count) over usual care?
timeFrame: 12 weeks
measure: Does activity level feedback have a greater impact on Quality of Life (QOL) than usual care? Indices of QOL will be multiple questionnaire scores entered together in a single analysis.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
Study officials:
affiliation: East Carolina Univerity
name: Ashley Burch
role: PRINCIPAL_INVESTIGATOR
affiliation: East Carolina Univerity
name: Samuel Sears
role: PRINCIPAL_INVESTIGATOR
References: