Physical ActivityNCT02531022

Evaluating Increasing Physical Activity After Acute Coronary Syndrome

A study testing Financial incentive and Daily feedback in people with Physical Activity and Acute Coronary Syndrome, run by University of Pennsylvania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives. All participants in will establish a baseline step count during the first two weeks and then proceed to a 16-week intervention period and 8-week… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Physical Activity, Acute Coronary Syndrome
What is being tested?: Financial incentive and Daily feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: No sites listed yet
Study dates: Feb 2016to 3 Apr 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥18 years;
ability to read and provide informed consent to participate in the study;
History of a) acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction); or b) patients having undergone coronary catheterization for suspected coronary artery disease.

Who cannot join

Inability to provide informed consent;
does not have daily access to a smartphone compatible with the wearable device;
unable or unwilling to complete the baseline 6-minute walk test and return to perform the 6-minute walk test at 10 and 18 weeks;
already enrolled in an exercise cardiac rehabilitation program prior to hospital admission;
hemodynamic instability or New York Heart Association III-IV heart failure;
any other medical conditions that would prohibit participation in an 18-week physical activity program;
not being discharged to home if recently admitted.

About this study

Official title: A Randomized, Controlled Trial Evaluating Methods to Use Physical Activity to Improve Outcomes After Acute Coronary Syndrome

Read the detailed description

Cardiovascular disease is the leading cause of mortality in the United States. Among patients that survive an acute myocardial infarction (AMI), cardiac rehabilitation (CR) has been demonstrated to effectively reduce risk of re-infarction, cardiac mortality, and all-cause mortality. However, despite cardiac rehabilitation being a Class I (standard of care) recommendation in multiple American Heart Association acute myocardial infarction guidelines, more than 80% of eligible patients do not receive appropriate cardiac rehabilitation and much of this is due to challenges in access to these programs. Recent innovations in technology allow us to passively monitor an individual's physical activity using wearable devices. Incentives designed using insights from behavioral economics have been demonstrated to motivate device engagement and behavior change. A remotely-monitored cardiac rehabilitation program could improve access for many individuals and potentially be more cost-effective because it is less resource- and personnel-intensive. The objective of this study is to use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives.

Conditions: Physical Activity, Acute Coronary Syndrome
Being tested: Financial incentive, Daily feedback
Medical subject headings: Motor Activity, Acute Coronary Syndrome

What participants receive

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

Financial incentiveBehavioural
A daily financial incentive framed as a loss of $2 each day goal is not acheived
Daily feedbackBehavioural
Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns

Study groups in NCT02531022
Study group	Role	What they receive
Control	Active comparator	Participants will be given standard exercise recommendations that are given to all patients based on the federal guidelines. They will monitor their step counts using a wearable device and receive daily feedback. Receives: Behavioral: Daily feedback
Intervention	Experimental	Participants will be given a wearable device to monitor daily step counts with automated daily feedback on goal attainment via text message or email. A baseline step count will be calculated for each participant (weeks 1-2) and then they will be given a daily step goal with an increase of 15 percentage point each week during the 8-week ramp-up period (weeks 3-10) with a maximum goal of 10,000 steps. Then they'll be asked to maintain that step count (maintenance period). During the ramp-up and maintenance period they'll have a financial incentive of $14 allocated each week and $2 taken away each day the goal is not achieved. They'll be followed up for 8 weeks without incentives Receives: Behavioral: Financial incentive; Behavioral: Daily feedback

What is being measured

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

Change in Mean Daily Steps
The primary outcome variable is the change in mean daily step count from the baseline period to the maintenance period (weeks 9-16).
Measured: Baseline and end of Maintenance Period at Week 16

Secondary outcomes (1)

Change in Mean Daily Steps From Baseline to Follow-up Period
Secondary outcomes include change in mean daily steps from the baseline period to the follow-up period (weeks 17-24).
Measured: Baseline and end of Follow Up Period at week 24

Timeline

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

Feb 20163 Apr 2017

First posted21 Aug 2015 (estimated)
Study startFeb 2016
Primary completionFeb 2017
Study completion3 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Physical ActivityStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02531022
Sponsor's protocol ID: 823025
Status last verified: Jul 2019
First submitted: 19 Aug 2015
Last updated: 11 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Fortunato M, Adusumalli S, Chokshi N, Harrison J, Rareshide C, Patel M. Usability of Wearable Devices to Remotely Monitor Sleep Patterns Among Patients With Ischemic Heart Disease: Observational Study. JMIR Form Res. 2020 Apr 7;4(4):e14508. doi: 10.2196/14508.
PubMed 32254044
Chokshi NP, Adusumalli S, Small DS, Morris A, Feingold J, Ha YP, Lynch MD, Rareshide CAL, Hilbert V, Patel MS. Loss-Framed Financial Incentives and Personalized Goal-Setting to Increase Physical Activity Among Ischemic Heart Disease Patients Using Wearable Devices: The ACTIVE REWARD Randomized Trial. J Am Heart Assoc. 2018 Jun 13;7(12):e009173. doi: 10.1161/JAHA.118.009173.
PubMed 29899015

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

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All Physical Activity trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Trial Evaluating Methods to Use Physical Activity to Improve Outcomes After Acute Coronary Syndrome
ClinicalTrials.gov ID: NCT02531022
Acronym / sponsor ID: 823025
Conditions: Physical Activity, Acute Coronary Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: Feb 2016 (actual)
Primary completion: Feb 2017 (actual)
Study completion: 3 Apr 2017 (actual)
First posted: 21 Aug 2015 (estimated)
Results: Posted 11 Jul 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Behavioral: Daily feedbackParticipants will be given standard exercise recommendations that are given to all patients based on the federal guidelines. They will monitor their step counts using a wearable device and receive daily feedback.
Intervention	Experimental	Behavioral: Financial incentive, Behavioral: Daily feedbackParticipants will be given a wearable device to monitor daily step counts with automated daily feedback on goal attainment via text message or email. A baseline step count will be calculated for each participant (weeks 1-2) and then they will be given a daily step goal with an increase of 15 percentage point each week during the 8-week ramp-up period (weeks 3-10) with a maximum goal of 10,000 steps. Then they'll be asked to maintain that step count (maintenance period). During the ramp-up and maintenance period they'll have a financial incentive of $14 allocated each week and $2 taken away each day the goal is not achieved. They'll be followed up for 8 weeks without incentives

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥18 years;
ability to read and provide informed consent to participate in the study;
History of a) acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction); or b) patients having undergone coronary catheterization for suspected coronary artery disease.

Key exclusion criteria (7 listed)

Inability to provide informed consent;
does not have daily access to a smartphone compatible with the wearable device;
unable or unwilling to complete the baseline 6-minute walk test and return to perform the 6-minute walk test at 10 and 18 weeks;
already enrolled in an exercise cardiac rehabilitation program prior to hospital admission;
hemodynamic instability or New York Heart Association III-IV heart failure;

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
Financial incentiveA daily financial incentive framed as a loss of $2 each day goal is not acheived	Behavioural	Intervention
Daily feedbackDaily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns	Behavioural	Control, Intervention

Primary outcome

Change in Mean Daily Steps
Time frame: Baseline and end of Maintenance Period at Week 16
The primary outcome variable is the change in mean daily step count from the baseline period to the maintenance period (weeks 9-16).

1 secondary outcome

Change in Mean Daily Steps From Baseline to Follow-up Period
Time frame: Baseline and end of Follow Up Period at week 24

Results and safety

Results posted to the registry on 11 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Exercise/Control	55	55
Daily Feedback With Financial Incentive	50	48

Primary outcome: Change in Mean Daily Steps

Time frame: Baseline and end of Maintenance Period at Week 16. Mean (95% Confidence Interval). Unit: Steps

Measure	Control n = 55	Intervention n = 50
Value	264 (95 to 433)	1501 (1280 to 1722)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through study completion (6 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 55 (0%)	0 of 55 (0%)	0 of 55
Intervention	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): Patients were from 4 hospitals in Southeastern Pennsylvania and had to use a smartphone or tablet. Physical activity measures were limited to only step counts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32254044Fortunato M, Adusumalli S, Chokshi N, Harrison J, Rareshide C, Patel M. Usability of Wearable Devices to Remotely Monitor Sleep Patterns Among Patients With Ischemic Heart Disease: Observational Study. JMIR Form Res. 2020 Apr 7;4(4):e14508. doi: 10.2196/14508.
Derived from this study: PubMed 29899015Chokshi NP, Adusumalli S, Small DS, Morris A, Feingold J, Ha YP, Lynch MD, Rareshide CAL, Hilbert V, Patel MS. Loss-Framed Financial Incentives and Personalized Goal-Setting to Increase Physical Activity Among Ischemic Heart Disease Patients Using Wearable Devices: The ACTIVE REWARD Randomized Trial. J Am Heart Assoc. 2018 Jun 13;7(12):e009173. doi: 10.1161/JAHA.118.009173.
Individual participant dataSharing planned: No

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Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
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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.

Mitesh Patel, MD, MBA, MS principal investigator

University of Pennsylvania

Questions about this trial

What is this clinical trial studying?

A study testing Financial incentive and Daily feedback in people with Physical Activity and Acute Coronary Syndrome, run by University of Pennsylvania.

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 3 inclusion and 7 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: finished, as of the sponsor's last update on 11 Jul 2019. 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?

Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Mean Daily Steps (time frame: Baseline and end of Maintenance Period at Week 16). 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 NCT02531022, which also lists 2 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 11 Jul 2019.