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OpenTrials
Completed

NCT Number: NCT03084458

Does Activity Feedback Increase ICD Patient Activity Levels?

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.

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Key information

Conditions

ICD Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Fitbit

Behavioral

The Fitbit device will allow experimental group participant access to their daily step count.

Primary outcomes

  1. Does increased access to information on daily activity level (FitBit) increase device (ICD) coded total activity (step count) over usual care?

    Time frame: 12 weeks

    At the final study visit, the ICD will be interrogated. Accelerometer data will be captured and used as a precise measure of physical activity, specifically, steps per day.

    Analyses will be conducted to determine activity (step count) changes between groups and over time.

  2. 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.

    Time frame: 12 weeks

    Questionnaires that will be used include: Cardiac Anxiety Questionnaire, Duke Activity Status Index, Fitbit Technology Satisfaction, Florida Patient Acceptance Survey, Florida Shock Anxiety Scale, Patient Health Security, Self-Care of Heart Failure Index, and the Short-Form 12 Health Survey. Analyses will be conducted to determine quality of life changes between groups and over time from the baseline, month 1, and month 3 visits.

Sponsors and collaborators

Lead sponsor

Ashley Burch

Other

Collaborators

  • Medtronic
  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2017
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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