Does Activity Feedback Increase ICD Patient Activity Levels?
NCT ID: NCT03084458
Last Updated: 2021-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2017-02-14
2018-06-11
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control
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.
No interventions assigned to this group
Fitbit
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.
Fitbit
The Fitbit device will allow experimental group participant access to their daily step count.
Interventions
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Fitbit
The Fitbit device will allow experimental group participant access to their daily step count.
Eligibility Criteria
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Inclusion Criteria
* access to a smartphone, tablet, or computer with internet access
* English speaking
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
University of North Carolina, Chapel Hill
OTHER
Ashley Burch
OTHER
Responsible Party
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Ashley Burch
PI
Principal Investigators
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Ashley Burch
Role: PRINCIPAL_INVESTIGATOR
East Carolina Univerity
Samuel Sears
Role: PRINCIPAL_INVESTIGATOR
East Carolina Univerity
Locations
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University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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CR3535
Identifier Type: -
Identifier Source: org_study_id
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