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Cardiovascular Risk FactorsNCT02548793

CPR Education Via a Mobile Application Compared to VSI Kit

A study testing Education: CPR Training via Mobile App and Education: CPR Training using the CPR Anytime VSI Kit in people with Cardiovascular Risk Factors and Coronary Disease, run by University of Pennsylvania at 7 sites in United States.

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

Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than one third of witnessed SCA events. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Education: CPR Training via Mobile App and Education: CPR Training using the CPR Anytime VSI Kit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,679 participants
Where
7 sitesUnited States
Study dates
Jan 2016to Oct 2018
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

  • Subjects must be present with their family member at the hospital
  • The family member must be at high risk for cardiac arrest (CA), including:
  • previous myocardial infarction (MI)
  • previous CA
  • history of diabetes
  • history of high cholesterol
  • history of high blood pressure
  • This includes subjects with family members being discharged from the Cardiac Intermediate Care Unit (CICU), Telemetry units, ICU, Cardiac Care Unit (CCU), cardiology clinics, or physicians office within the participating hospitals/health systems

Who cannot join

  • Volunteers and subjects must be 18 years of age or older
  • Individual must be fit and able to perform moderate physical activity
  • Volunteers must be English speaking and/or Spanish speaking

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19106

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Crozer-Keystone Health System

    Upland, Pennsylvania, 19013

  • The Chester County Hospital and Health System

    West Chester, Pennsylvania, 19380

Other trials in United States

About this study

Official title: CPR Education for Families of Cardiac Patients Before Hospital Discharge

Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than one third of witnessed SCA events. A number of barriers to bystander CPR training have been identified including time and cost of the training course. Since the large majority of arrest events occur in the home environment, studies have suggested that providing CPR training to family members of hospitalized cardiac patients may serve as a useful approach to address an environment in which bystander CPR is frequently not provided. Utilizing an existing in-hospital program to train adult family members, the investigators will assess the skills of those who learn CPR through two different educational methods: a mobile app and video self-instruction (VSI).

Read the detailed description

The long term goal of the investigators work is to implement real world CPR training strategies that match training locales with at-risk populations, maximize resuscitation skill retention, and promote willingness to act. To accomplish this, the investigators will empower stakeholders at the University of Pennsylvania Health System (UPHS) and local area hospitals to develop local implementation approaches, using either volunteer hospital personnel or paid research assistants as training proctors. These stakeholders will be studied as a research subset. The training proctors will educate family members or friends of patients at risk for cardiac arrest using a mobile application "app" or VSI kit (RCT), and empower them with the lifesaving skill of CPR. The investigators will follow up with the study subjects and conduct CPR skills tests 6 to 12 months from the time of training to assess whether the subjects retained their skills or if they had an opportunity to use the skills that they learned. The investigators will also gather information on how the subjects would like to be encouraged to practice their skills. The investigators will send a reminder notification every two months following training, to encourage subjects to refresh their training skills. At the follow-up skills test at 6 to 12 months, the investigators will administer a survey to assess whether the prompting encouraged the subjects to practice their skills. Additionally the investigators will encourage the individuals trained in-hospital to share the kit or mobile app with others. The investigators will follow-up with those who are identified as secondary trainees to assess the environment in which secondary training took place.

Being tested
Education: CPR Training via Mobile App, Education: CPR Training using the CPR Anytime VSI Kit
Keywords
Cardiac Arrest, CPR, Family-centered Care, Health Literacy, Health Education, Education Dissemination
Medical subject headings
Coronary Disease, Heart Arrest, Health Education

What participants receive

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

  • Education: CPR Training via Mobile AppOther

    Also called CPR Training Cellphone App

    Using a mobile app to train users on chest-compression only CPR. Subjects will be encouraged to share the app with family and friends.

  • Education: CPR Training using the CPR Anytime VSI KitOther

    Also called Family and Friends CPR Anytime, American Heart Association Family and Friends CPR Anytime, CPR Anytime Video Self Instruction (VSI)

    Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit. Subjects will undergo training in-hospital and will be encouraged to take the kit home to share with their family members and friends.

Study groups in NCT02548793
Study groupRoleWhat they receive
VSI KitActive comparatorEducation: CPR Training using the CPR Anytime VSI Kit Individuals will learn chest-compression only CPR (no rescue breaths) using the American Heart Association's Family and Friends CPR Anytime Kit. Subjects will undergo training in-hospital and will be encouraged to take the kit home to share with their family members and friends.
Receives: Other: Education: CPR Training using the CPR Anytime VSI Kit
Mobile ApplicationExperimentalEducation: CPR Training via Mobile App Individuals will learn chest-compression only CPR (no rescue breaths) using a newly developed mobile training application.
Receives: Other: Education: CPR Training via Mobile App

What is being measured

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

  1. Chest compression depth

    Depth of chest compression performed by the subject, recorded using the Laerdal SimPad®. This metric will be measured in millimeters (mm). This outcome measure will be collected by research coordinators during 6-month in-home follow-up visits.

    Measured: 6 months

  2. Chest compression rate

    Rate of chest compressions performed by the subject, recorded using the Laerdal SimPad®. This metric will be measured as the number of compressions performed in a 2 minute window. This outcome measure will be collected by research coordinators during 6-month in-home follow-up visits.

    Measured: 6 months

Secondary outcomes (2)
  1. Secondary CPR training rates

    Calculate the number of secondary trainees based on study participant self-reporting (via survey) collected during the 6-month follow-up.

    Measured: 6 months

  2. Incidence of bystander CPR provided by subjects

    Using 6 month and 12 month follow-up surveys, subjects will be asked if they had an opportunity to use their CPR skills in a real-life situation and whether or not they performed CPR in the aforementioned situation.

    Measured: 6-12 months

Timeline

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

  1. First posted14 Sep 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionOct 2018
  4. Study completionOct 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,679 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02548793
Sponsor's protocol ID
822593
Status last verified
Oct 2018
First submitted
31 Aug 2015
Last updated
17 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Blewer AL, Leary M, Decker CS, Andersen JC, Fredericks AC, Bobrow BJ, Abella BS. Cardiopulmonary resuscitation training of family members before hospital discharge using video self-instruction: a feasibility trial. J Hosp Med. 2011 Sep;6(7):428-32. doi: 10.1002/jhm.847. Epub 2010 Nov 8.

    PubMed 21916007
  • Blewer AL, Leary M, Esposito EC, Gonzalez M, Riegel B, Bobrow BJ, Abella BS. Continuous chest compression cardiopulmonary resuscitation training promotes rescuer self-confidence and increased secondary training: a hospital-based randomized controlled trial*. Crit Care Med. 2012 Mar;40(3):787-92. doi: 10.1097/CCM.0b013e318236f2ca.

    PubMed 22080629
  • Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.

    PubMed 24446411
  • Rea TD, Helbock M, Perry S, Garcia M, Cloyd D, Becker L, Eisenberg M. Increasing use of cardiopulmonary resuscitation during out-of-hospital ventricular fibrillation arrest: survival implications of guideline changes. Circulation. 2006 Dec 19;114(25):2760-5. doi: 10.1161/CIRCULATIONAHA.106.654715. Epub 2006 Dec 11.

    PubMed 17159062
  • Stiell IG, Wells GA, Field B, Spaite DW, Nesbitt LP, De Maio VJ, Nichol G, Cousineau D, Blackburn J, Munkley D, Luinstra-Toohey L, Campeau T, Dagnone E, Lyver M; Ontario Prehospital Advanced Life Support Study Group. Advanced cardiac life support in out-of-hospital cardiac arrest. N Engl J Med. 2004 Aug 12;351(7):647-56. doi: 10.1056/NEJMoa040325.

    PubMed 15306666
  • Bagai A, McNally BF, Al-Khatib SM, Myers JB, Kim S, Karlsson L, Torp-Pedersen C, Wissenberg M, van Diepen S, Fosbol EL, Monk L, Abella BS, Granger CB, Jollis JG. Temporal differences in out-of-hospital cardiac arrest incidence and survival. Circulation. 2013 Dec 17;128(24):2595-602. doi: 10.1161/CIRCULATIONAHA.113.004164. Epub 2013 Sep 17.

    PubMed 24045044
  • Cobb LA, Fahrenbruch CE, Walsh TR, Copass MK, Olsufka M, Breskin M, Hallstrom AP. Influence of cardiopulmonary resuscitation prior to defibrillation in patients with out-of-hospital ventricular fibrillation. JAMA. 1999 Apr 7;281(13):1182-8. doi: 10.1001/jama.281.13.1182.

    PubMed 10199427
  • Holmberg M, Holmberg S, Herlitz J; Swedish Cardiac Arrest Registry. Factors modifying the effect of bystander cardiopulmonary resuscitation on survival in out-of-hospital cardiac arrest patients in Sweden. Eur Heart J. 2001 Mar;22(6):511-9. doi: 10.1053/euhj.2000.2421.

    PubMed 11320981
  • Iwami T, Kawamura T, Hiraide A, Berg RA, Hayashi Y, Nishiuchi T, Kajino K, Yonemoto N, Yukioka H, Sugimoto H, Kakuchi H, Sase K, Yokoyama H, Nonogi H. Effectiveness of bystander-initiated cardiac-only resuscitation for patients with out-of-hospital cardiac arrest. Circulation. 2007 Dec 18;116(25):2900-7. doi: 10.1161/CIRCULATIONAHA.107.723411. Epub 2007 Dec 10.

    PubMed 18071072
  • Anderson ML, Cox M, Al-Khatib SM, Nichol G, Thomas KL, Chan PS, Saha-Chaudhuri P, Fosbol EL, Eigel B, Clendenen B, Peterson ED. Rates of cardiopulmonary resuscitation training in the United States. JAMA Intern Med. 2014 Feb 1;174(2):194-201. doi: 10.1001/jamainternmed.2013.11320.

    PubMed 24247329
  • Nichol G, Thomas E, Callaway CW, Hedges J, Powell JL, Aufderheide TP, Rea T, Lowe R, Brown T, Dreyer J, Davis D, Idris A, Stiell I; Resuscitation Outcomes Consortium Investigators. Regional variation in out-of-hospital cardiac arrest incidence and outcome. JAMA. 2008 Sep 24;300(12):1423-31. doi: 10.1001/jama.300.12.1423.

    PubMed 18812533
  • Sasson C, Rogers MA, Dahl J, Kellermann AL. Predictors of survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):63-81. doi: 10.1161/CIRCOUTCOMES.109.889576. Epub 2009 Nov 10.

    PubMed 20123673
  • Abella BS, Aufderheide TP, Eigel B, Hickey RW, Longstreth WT Jr, Nadkarni V, Nichol G, Sayre MR, Sommargren CE, Hazinski MF; American Heart Association. Reducing barriers for implementation of bystander-initiated cardiopulmonary resuscitation: a scientific statement from the American Heart Association for healthcare providers, policymakers, and community leaders regarding the effectiveness of cardiopulmonary resuscitation. Circulation. 2008 Feb 5;117(5):704-9. doi: 10.1161/CIRCULATIONAHA.107.188486. Epub 2008 Jan 14. No abstract available.

    PubMed 18195177
  • Cho GC, Sohn YD, Kang KH, Lee WW, Lim KS, Kim W, Oh BJ, Choi DH, Yeom SR, Lim H. The effect of basic life support education on laypersons' willingness in performing bystander hands only cardiopulmonary resuscitation. Resuscitation. 2010 Jun;81(6):691-4. doi: 10.1016/j.resuscitation.2010.02.021. Epub 2010 Mar 26.

    PubMed 20347208
  • Swor R, Compton S. Estimating cost-effectiveness of mass cardiopulmonary resuscitation training strategies to improve survival from cardiac arrest in private locations. Prehosp Emerg Care. 2004 Oct-Dec;8(4):420-3. doi: 10.1016/j.prehos.2004.06.012.

    PubMed 15626005

Questions about this trial

What is this clinical trial studying?

A study testing Education: CPR Training via Mobile App and Education: CPR Training using the CPR Anytime VSI Kit in people with Cardiovascular Risk Factors and Coronary Disease, run by University of Pennsylvania at 7 sites in United States.

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 8 inclusion and 3 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 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Chest compression depth (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02548793, which also lists 18 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 17 Jan 2019.

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