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Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device (INCENTIVE)

Primary Purpose

Acute Coronary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fitbit Charge HR
Sponsored by
North Texas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Coronary Syndrome focused on measuring Percutaneous Transluminal Coronary Intervention, Cardiac Rehabilitation, Fitbit Charge HR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or greater
  • Willing and able to give informed consent
  • Successful, clinically-indicated PCI with no plan for staged procedure
  • Clinically stable and able to exercise
  • Access to smartphone (Apple or Android platform)
  • Completed 10 weeks of CR and is expected to graduate program.

Exclusion Criteria:

  • Plan for PCI or other major surgical procedure, which would limit exercise capability, within the 14 weeks following study enrollment.
  • Home oxygen requirement
  • Amputation, peripheral arterial disease, other musculoskeletal or neurological disease affecting mobility
  • End-stage renal disease
  • Ongoing Unstable angina or CCS IV angina
  • NYHA IV heart failure
  • Terminal illness
  • Dementia
  • Fall risk (inability to hold semi-tandem stance for 10 seconds)
  • Pregnant women and prisoners
  • Any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Fitbit Charge HR

    No Device

    Arm Description

    Use of the Fitbit Charge HR, a simple, user-friendly, wrist-worn, commercially available device which provides feedback on exercise goal adherence, in combination with the Fitbit mobile platform application. All patients will wear the Actigraph wGT3X-BT, from which data is extracted. Actigraph does not provide patient any feedback.

    No Fitbit used and no feedback on exercise goal adherence. All patients will wear the Actigraph wGT3X-BT, from which data is extracted. Actigraph does not provide patient any feedback.

    Outcomes

    Primary Outcome Measures

    Relative change in average number of steps taken per day

    Secondary Outcome Measures

    Relative change in average daily energy expenditure measured in % change in the average number of calories (kcal) expended per day
    Average daily energy expenditure will be measured in kcal/day by the Actigraph wGT3X-BT device.
    Relative change in average number of daily activity bouts measured in % change in the average number of activity bouts per day
    Activity bouts will be measured as periods of continuous activity recorded by the Actigraph wGT3X-BT device.
    Relative change in average number of daily sedentary bouts measured in % change in the average number of sedentary bouts per day
    Sedentary bouts will be measured as periods of prolonged inactivity recorded by the Actigraph wGT3X-BT device. Non-wear time periods are excluded from this analysis.
    Relative change in average daily sleep efficiency measured in % change in average sleep efficiency. Sleep efficiency will also be measured in %.
    Sleep efficiency will be measured in % using data from the Actigraph wGT3X-BT device.
    Relative change in average weekly moderate/vigorous physical activity, measured in % change in minutes spent in moderate/vigorous physical activity per week
    change in weekly time of moderate/vigorous physical activity (MVPA, defined as activity intensity of ≥3.0 metabolic equivalents [MET] or ≥100 steps/min) (minutes).
    Relative change in quality of life, measured in % change in SF-36 health survey questionnaire score
    change in quality of life (as assessed by the Short Form Health (SF36) questionnaire).
    Relative change in indicators of depression, measured in % change in PHQ9 questionnaire score
    change in indicators of depression (as assessed by the Patient Health (PHQ9) questionnaire).
    Relative change in medication adherence, measured in % change in MMAS questionnaire score
    change in medication adherence (as assessed by the Morisky Medication Adherence Scale (MMAS-8).
    Relative change in HDL and LDL cholesterol
    Relative change in BMI
    Relative change in resting heart rate
    Relative change in exercise stress test performance
    Relative change in blood pressure (BP)
    Relative change in waist circumference

    Full Information

    First Posted
    May 20, 2016
    Last Updated
    May 27, 2016
    Sponsor
    North Texas Veterans Healthcare System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02788929
    Brief Title
    Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device
    Acronym
    INCENTIVE
    Official Title
    INCreasing Exercise adhereNce After percuTaneous Coronary InterVEntion With the Fitbit Charge HR Device: the INCENTIVE Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    North Texas Veterans Healthcare System

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Design: Single center, prospective, randomized study that will compare activity levels in patients who complete cardiac rehabilitation after clinically indicated percutaneous coronary intervention with and without use of the wrist-worn Fitbit Charge HR device and mobile platform application. Primary Endpoint: The average number of steps taken per day will serve as the main marker of daily physical activity. Control: Patients who do not receive the device (Fitbit Charge HR). Secondary Endpoints: (1) change in daily energy expenditure (2) change in number of activity and sedentary bouts (3) change in sleep efficiency (4) change in weekly time of moderate/vigorous physical activity (5) change in quality of life (6) change in indicators of depression (7) change in medication adherence(8) change in HDL and LDL cholesterol (9) change in BMI and waist circumference (10) change in resting heart rate and blood pressure (11) change in exercise stress test performance (timeframe for all: baseline - 12 weeks)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Coronary Syndrome
    Keywords
    Percutaneous Transluminal Coronary Intervention, Cardiac Rehabilitation, Fitbit Charge HR

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fitbit Charge HR
    Arm Type
    Active Comparator
    Arm Description
    Use of the Fitbit Charge HR, a simple, user-friendly, wrist-worn, commercially available device which provides feedback on exercise goal adherence, in combination with the Fitbit mobile platform application. All patients will wear the Actigraph wGT3X-BT, from which data is extracted. Actigraph does not provide patient any feedback.
    Arm Title
    No Device
    Arm Type
    No Intervention
    Arm Description
    No Fitbit used and no feedback on exercise goal adherence. All patients will wear the Actigraph wGT3X-BT, from which data is extracted. Actigraph does not provide patient any feedback.
    Intervention Type
    Device
    Intervention Name(s)
    Fitbit Charge HR
    Intervention Description
    Patients randomized to the FitBit group will receive Fitbit Charge HR, a simple, user-friendly, wrist-worn, commercially available device which provides feedback on exercise goal adherence, in combination with the Fitbit mobile platform application.
    Primary Outcome Measure Information:
    Title
    Relative change in average number of steps taken per day
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Secondary Outcome Measure Information:
    Title
    Relative change in average daily energy expenditure measured in % change in the average number of calories (kcal) expended per day
    Description
    Average daily energy expenditure will be measured in kcal/day by the Actigraph wGT3X-BT device.
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in average number of daily activity bouts measured in % change in the average number of activity bouts per day
    Description
    Activity bouts will be measured as periods of continuous activity recorded by the Actigraph wGT3X-BT device.
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in average number of daily sedentary bouts measured in % change in the average number of sedentary bouts per day
    Description
    Sedentary bouts will be measured as periods of prolonged inactivity recorded by the Actigraph wGT3X-BT device. Non-wear time periods are excluded from this analysis.
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in average daily sleep efficiency measured in % change in average sleep efficiency. Sleep efficiency will also be measured in %.
    Description
    Sleep efficiency will be measured in % using data from the Actigraph wGT3X-BT device.
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in average weekly moderate/vigorous physical activity, measured in % change in minutes spent in moderate/vigorous physical activity per week
    Description
    change in weekly time of moderate/vigorous physical activity (MVPA, defined as activity intensity of ≥3.0 metabolic equivalents [MET] or ≥100 steps/min) (minutes).
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in quality of life, measured in % change in SF-36 health survey questionnaire score
    Description
    change in quality of life (as assessed by the Short Form Health (SF36) questionnaire).
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in indicators of depression, measured in % change in PHQ9 questionnaire score
    Description
    change in indicators of depression (as assessed by the Patient Health (PHQ9) questionnaire).
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in medication adherence, measured in % change in MMAS questionnaire score
    Description
    change in medication adherence (as assessed by the Morisky Medication Adherence Scale (MMAS-8).
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in HDL and LDL cholesterol
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in BMI
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in resting heart rate
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in exercise stress test performance
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in blood pressure (BP)
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation
    Title
    Relative change in waist circumference
    Time Frame
    Baseline and 12 weeks after completion of cardiac rehabilitation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or greater Willing and able to give informed consent Successful, clinically-indicated PCI with no plan for staged procedure Clinically stable and able to exercise Access to smartphone (Apple or Android platform) Completed 10 weeks of CR and is expected to graduate program. Exclusion Criteria: Plan for PCI or other major surgical procedure, which would limit exercise capability, within the 14 weeks following study enrollment. Home oxygen requirement Amputation, peripheral arterial disease, other musculoskeletal or neurological disease affecting mobility End-stage renal disease Ongoing Unstable angina or CCS IV angina NYHA IV heart failure Terminal illness Dementia Fall risk (inability to hold semi-tandem stance for 10 seconds) Pregnant women and prisoners Any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emmanouil S Brilakis, MD, PhD
    Organizational Affiliation
    North Texas Veterans Healthcare System
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22064601
    Citation
    Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011 Dec 6;124(23):e574-651. doi: 10.1161/CIR.0b013e31823ba622. Epub 2011 Nov 7. No abstract available. Erratum In: Circulation. 2012 Feb 28;125(8):e412. Dosage error in article text.
    Results Reference
    background
    PubMed Identifier
    21576654
    Citation
    Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.
    Results Reference
    background
    PubMed Identifier
    12576911
    Citation
    Moore SM, Dolansky MA, Ruland CM, Pashkow FJ, Blackburn GG. Predictors of women's exercise maintenance after cardiac rehabilitation. J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):40-9. doi: 10.1097/00008483-200301000-00008.
    Results Reference
    background
    PubMed Identifier
    20128541
    Citation
    Dolansky MA, Stepanczuk B, Charvat JM, Moore SM. Women's and men's exercise adherence after a cardiac event. Res Gerontol Nurs. 2010 Jan;3(1):30-8. doi: 10.3928/19404921-20090706-03. Epub 2010 Jan 27.
    Results Reference
    background
    PubMed Identifier
    16472039
    Citation
    Moore SM, Charvat JM, Gordon NH, Pashkow F, Ribisl P, Roberts BL, Rocco M. Effects of a CHANGE intervention to increase exercise maintenance following cardiac events. Ann Behav Med. 2006 Feb;31(1):53-62. doi: 10.1207/s15324796abm3101_9.
    Results Reference
    background
    PubMed Identifier
    18029834
    Citation
    Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
    Results Reference
    background
    PubMed Identifier
    15829777
    Citation
    Izawa KP, Watanabe S, Omiya K, Hirano Y, Oka K, Osada N, Iijima S. Effect of the self-monitoring approach on exercise maintenance during cardiac rehabilitation: a randomized, controlled trial. Am J Phys Med Rehabil. 2005 May;84(5):313-21. doi: 10.1097/01.phm.0000156901.95289.09.
    Results Reference
    background
    PubMed Identifier
    17911274
    Citation
    Bohannon RW. Number of pedometer-assessed steps taken per day by adults: a descriptive meta-analysis. Phys Ther. 2007 Dec;87(12):1642-50. doi: 10.2522/ptj.20060037. Epub 2007 Oct 2.
    Results Reference
    background
    PubMed Identifier
    15617619
    Citation
    VanWormer JJ, Boucher JL, Pronk NP, Thoennes JJ. Lifestyle behavior change and coronary artery disease: effectiveness of a telephone-based counseling program. J Nutr Educ Behav. 2004 Nov-Dec;36(6):333-4. doi: 10.1016/s1499-4046(06)60406-5. No abstract available.
    Results Reference
    background

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    Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device

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