Acute Coronary SyndromeINCENTIVENCT02788929

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

A study testing Fitbit Charge HR in people with Acute Coronary Syndrome, run by North Texas Veterans Healthcare System.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Fitbit Charge HR
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: May 2016to May 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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.

About this study

Official title: INCreasing Exercise adhereNce After percuTaneous Coronary InterVEntion With the Fitbit Charge HR Device: the INCENTIVE Trial

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)

Conditions: Acute Coronary Syndrome
Being tested: Fitbit Charge HR
Keywords: Percutaneous Transluminal Coronary Intervention, Cardiac Rehabilitation, Fitbit Charge HR
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fitbit Charge HRDevice
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.

Study groups in NCT02788929
Study group	Role	What they receive
Fitbit Charge HR	Active comparator	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. Receives: Device: Fitbit Charge HR
No Device	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative change in average number of steps taken per day
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation

Secondary outcomes (14)

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.
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
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.
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
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.
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
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.
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
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).
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
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).
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
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).
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
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).
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in HDL and LDL cholesterol
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in BMI
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in resting heart rate
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in exercise stress test performance
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in blood pressure (BP)
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in waist circumference
Measured: Baseline and 12 weeks after completion of cardiac rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016May 2017

First posted2 Jun 2016 (estimated)
Study startMay 2016
Primary completionMay 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02788929
Sponsor's protocol ID: 16-008
Acronym: INCENTIVE
Status last verified: May 2016
First submitted: 20 May 2016
Last updated: 2 Jun 2016
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 22064601
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.
PubMed 21576654
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.
PubMed 12576911
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.
PubMed 20128541
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.
PubMed 16472039
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.
PubMed 18029834
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.
PubMed 15829777
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.
PubMed 17911274
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.
PubMed 15617619

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Enrolling by invitationObservational study
Prevalence of CYP2C19 Genetic Polymorphisms Among Egyptian Patients Receiving Clopidogrel Following PCI
Acute Coronary Syndrome

All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: INCreasing Exercise adhereNce After percuTaneous Coronary InterVEntion With the Fitbit Charge HR Device: the INCENTIVE Trial
ClinicalTrials.gov ID: NCT02788929
Acronym / sponsor ID: INCENTIVE / 16-008
Conditions: Acute Coronary Syndrome
Keywords: Percutaneous Transluminal Coronary Intervention, Cardiac Rehabilitation, Fitbit Charge HR
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: North Texas Veterans Healthcare SystemUS federal agency
Study start: May 2016
Primary completion: May 2017 (estimated)
First posted: 2 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fitbit Charge HR	Active comparator	Device: Fitbit Charge HRUse 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 Device	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fitbit Charge HRPatients 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.	Device	Fitbit Charge HR

Primary outcome

Relative change in average number of steps taken per day
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation

14 secondary outcomes

Relative change in average daily energy expenditure measured in % change in the average number of calories (kcal) expended per day
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in average number of daily activity bouts measured in % change in the average number of activity bouts per day
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in average number of daily sedentary bouts measured in % change in the average number of sedentary bouts per day
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in average daily sleep efficiency measured in % change in average sleep efficiency. Sleep efficiency will also be measured in %.
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in average weekly moderate/vigorous physical activity, measured in % change in minutes spent in moderate/vigorous physical activity per week
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in quality of life, measured in % change in SF-36 health survey questionnaire score
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in indicators of depression, measured in % change in PHQ9 questionnaire score
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in medication adherence, measured in % change in MMAS questionnaire score
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in HDL and LDL cholesterol
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in BMI
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in resting heart rate
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in exercise stress test performance
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in blood pressure (BP)
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in waist circumference
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
Background: PubMed 22064601Levine 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.
Background: PubMed 21576654Goel 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.
Background: PubMed 12576911Moore 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.
Background: PubMed 20128541Dolansky 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.
Background: PubMed 16472039Moore 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.
Background: PubMed 18029834Bravata 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.
Background: PubMed 15829777Izawa 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.
Background: PubMed 17911274Bohannon 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.
Background: PubMed 15617619VanWormer 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.

Related trials for Acute Coronary Syndrome

Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Enrolling by invitationObservational study
Prevalence of CYP2C19 Genetic Polymorphisms Among Egyptian Patients Receiving Clopidogrel Following PCI
Acute Coronary Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emmanouil S Brilakis, MD, PhD study chair

North Texas Veterans Healthcare System

Questions about this trial

What is this clinical trial studying?

A study testing Fitbit Charge HR in people with Acute Coronary Syndrome, run by North Texas Veterans Healthcare System.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in average number of steps taken per day (time frame: Baseline and 12 weeks after completion of cardiac rehabilitation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02788929, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.