- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02531022
Evaluating Increasing Physical Activity After Acute Coronary Syndrome
10. juli 2019 oppdatert av: University of Pennsylvania
A Randomized, Controlled Trial Evaluating Methods to Use Physical Activity to Improve Outcomes After Acute Coronary Syndrome
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 follow-up period.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
105
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Control
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.
|
Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
|
Eksperimentell: Intervention
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
|
Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
A daily financial incentive framed as a loss of $2 each day goal is not acheived
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Mean Daily Steps
Tidsramme: 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).
|
Baseline and end of Maintenance Period at Week 16
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Mean Daily Steps From Baseline to Follow-up Period
Tidsramme: Baseline and end of Follow Up Period at week 24
|
Secondary outcomes include change in mean daily steps from the baseline period to the follow-up period (weeks 17-24).
|
Baseline and end of Follow Up Period at week 24
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2016
Primær fullføring (Faktiske)
1. februar 2017
Studiet fullført (Faktiske)
3. april 2017
Datoer for studieregistrering
Først innsendt
19. august 2015
Først innsendt som oppfylte QC-kriteriene
20. august 2015
Først lagt ut (Anslag)
21. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juli 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juli 2019
Sist bekreftet
1. juli 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 823025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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