NCT02548793

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,679

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 17, 2019

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

August 31, 2015

Last Update Submit

January 15, 2019

Conditions

Keywords

Cardiac ArrestCPRFamily-centered CareHealth LiteracyHealth EducationEducation Dissemination

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 months

  • 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.

    6 months

Secondary Outcomes (2)

  • Secondary CPR training rates

    6 months

  • Incidence of bystander CPR provided by subjects

    6-12 months

Other Outcomes (1)

  • Qualitative analysis of patient's perspective of the family member's receiving hands-only CPR training using semi-structured

    6-12 months

Study Arms (2)

VSI Kit

ACTIVE COMPARATOR

Education: 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.

Other: Education: CPR Training using the CPR Anytime VSI Kit

Mobile Application

EXPERIMENTAL

Education: CPR Training via Mobile App Individuals will learn chest-compression only CPR (no rescue breaths) using a newly developed mobile training application.

Other: Education: CPR Training via Mobile App

Interventions

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

Also known as: CPR Training Cellphone App
Mobile Application

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.

Also known as: Family and Friends CPR Anytime, American Heart Association Family and Friends CPR Anytime, CPR Anytime Video Self Instruction (VSI)
VSI Kit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Crozer-Keystone Health System

Upland, Pennsylvania, 19013, United States

Location

The Chester County Hospital and Health System

West Chester, Pennsylvania, 19380, United States

Location

Related Publications (18)

  • 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.

    PMID: 21916007BACKGROUND
  • 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.

    PMID: 22080629BACKGROUND
  • 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.

    PMID: 24446411BACKGROUND
  • 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.

    PMID: 17159062BACKGROUND
  • 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.

    PMID: 15306666BACKGROUND
  • 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.

    PMID: 24045044BACKGROUND
  • 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.

    PMID: 10199427BACKGROUND
  • 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.

    PMID: 11320981BACKGROUND
  • 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.

    PMID: 18071072BACKGROUND
  • 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.

    PMID: 24247329BACKGROUND
  • 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.

    PMID: 18812533BACKGROUND
  • 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.

    PMID: 20123673BACKGROUND
  • 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.

    PMID: 18195177BACKGROUND
  • 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.

    PMID: 20347208BACKGROUND
  • 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.

    PMID: 15626005BACKGROUND
  • Brennan RT, Braslow A. Are we training the right people yet? A survey of participants in public cardiopulmonary resuscitation classes. Resuscitation. 1998 Apr;37(1):21-5. doi: 10.1016/s0300-9572(98)00026-4.

    PMID: 9667334BACKGROUND
  • Free C, Phillips G, Watson L, Galli L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis. PLoS Med. 2013;10(1):e1001363. doi: 10.1371/journal.pmed.1001363. Epub 2013 Jan 15.

    PMID: 23458994BACKGROUND
  • Blewer AL, Putt ME, McGovern SK, Murray AD, Leary M, Riegel B, Shea JA, Berg RA, Asch DA, Viera AJ, Merchant RM, Nadkarni VM, Abella BS; CHIP Study Group. A pragmatic randomized trial of cardiopulmonary resuscitation training for families of cardiac patients before hospital discharge using a mobile application. Resuscitation. 2020 Jul;152:28-35. doi: 10.1016/j.resuscitation.2020.04.026. Epub 2020 May 3.

Related Links

MeSH Terms

Conditions

Coronary DiseaseHeart ArrestHealth Education

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Benjamin S Abella, MD, MPhil

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 14, 2015

Study Start

January 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

January 17, 2019

Record last verified: 2018-10

Locations