Cardiovascular Risk FactorsNCT01514656
CPR Training: Video Self-Instruction Kit or Video-Only
A study testing CPR Training using the Family and Friends CPR Anytime Video Self Instruction, Implementation of a Hospital-based CPR Training Model and Follow-up prompting to encourage skill retention in people with Cardiovascular Risk Factors and Coronary Disease, run by University of Pennsylvania at 3 sites in United States.
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 olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Coronary Disease, Cardiac Arrest
- What is being tested?
- CPR Training using the Family and Friends CPR Anytime Video Self Instruction, Implementation of a Hospital-based CPR Training Model and Follow-up prompting to encourage skill retention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,870 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family Members of Patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.
Who cannot join
- If someone is physically unable to undergo CPR Training
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Hospital-based CPR Training for At-risk Family Members Using a Video-self Instruction Kit or Video-only
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 education methods (video-only and video self-instruction (VSI) kit).
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 UPHS and local area hospitals to develop local implementation approaches, using either volunteers or nursing staff as training proctors. These stakeholders will be studied as a research subset. The training proctors will train family members or friends of patients at risk for cardiac arrest using either a video-only method or video self-instruction (VSI) kit, and empower them with the lifesaving skill of CPR. The investigators will use the American Heart Association's CPR Anytime VSI kit which comes equip with a DVD and inflatable manikin. For the group receiving the video-only method, the investigators will remove the inflatable manikin and train the subjects with the DVD. The investigators will randomize family members of high risk for CA to either the video-only or VSI kit method of training. The training proctors will be instructed to switch training methods every 6 months. The investigators will follow up with the study subjects and conduct CPR skills tests from 6 to 12 months from 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 the subjects to refresh their training skills. At the follow-up skills test at 6 to 12 months, we will administer a survey to assess whether the prompting encouraged the subjects to practice their skills.
- Being tested
- CPR Training using the Family and Friends CPR Anytime Video Self Instruction, Implementation of a Hospital-based CPR Training Model, Follow-up prompting to encourage skill retention
- Medical subject headings
- Coronary Disease, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR Training using the Family and Friends CPR Anytime Video Self InstructionOther
Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Program. The subject's will undergo training in-hospital then they will be encouraged to take the training materials home with them to practice CPR with their family members and friends.
Implementation of a Hospital-based CPR Training ModelOther
Nurses and Volunteers will be trained in the hospital-based CPR Training Model, and be encouraged to implement the training program in their respective hospitals.
Follow-up prompting to encourage skill retentionOther
Subjects will be contacted every two months and encouraged to practice the skills that they have learned. Means of contact include: a) email b) text blasts c) phone calls d) social media e) mail
| Study group | Role | What they receive |
|---|---|---|
| Video Self-Instruction (VSI) kit | Active comparator | Individuals will learn CPR using American Heart Association's Video Self-Instruction kit. Main data points being collected at various increments over 12 months are: 1) CPR quality at 6 to 12 months 2) Comfort Level using the skills they learned Receives: Other: CPR Training using the Family and Friends CPR Anytime Video Self Instruction |
| Video-only | Experimental | Individuals will learn CPR skills using a Video training method. Main data points being collected at various increments over 12 months are: 1) CPR Skills at 6 to 12 months 2) Comfort Level with using CPR Receives: Other: CPR Training using the Family and Friends CPR Anytime Video Self Instruction |
| Recruitment with Volunteers | Active comparator | Volunteer subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals. Receives: Other: Implementation of a Hospital-based CPR Training Model |
| Recruitment with Nurses | Active comparator | Nurse subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals. Receives: Other: Implementation of a Hospital-based CPR Training Model |
| Prompting to practice skills | Active comparator | Individuals will be prompted every two months and encouraged to practice the skills that they learned. Main data points being collected at various increments over 12 months are: 1) Comfort Level with using CPR 2) CPR Skills at 6 to 12 months. Receives: Other: Follow-up prompting to encourage skill retention |
| No prompting to practice skills | Active comparator | Individuals will not be prompted to practice skills. Main data points being collected at various increments over 12 months are: 1) Comfort Level with using CPR 2) CPR Skills at 6 to 12 months. Receives: Other: Follow-up prompting to encourage skill retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR Skills Performance and Retention
To assess skills performance and retention by trainees (family members and friends) taught using a video-only method or video self-instruction kit. To assess whether prompting or reminding subjects (family members and friends) might encourage the subjects to practice their CPR skills and improve skills at time of testing. Subjects skills will be tested at 6 and 12 months period of time.
Measured: 6 months
Secondary outcomes (2)
Assessing CPR Training Proctors (Nurses or Volunteers)
To determine if volunteers or nursing staff can adequately implement a CPR training program to "at risk" family members or friends of patients hospitalized for cardiac risk factors. Subjects will be surveyed every 3 months to assess feasibility.
Measured: At 3 months, 6 months, 9 months and 12 months
Assess prompting to encourage CPR skills retention
To assess whether prompting subjects every two months encourages them to practice and retain the skills that they learned.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,870 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin S. Abella, MD, MPhil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514656
- Sponsor's protocol ID
- CRS- 814676
- Status last verified
- May 2023
- First submitted
- 12 Dec 2011
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 21916007Blewer 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 22080629Blewer AL, Putt ME, Becker LB, Riegel BJ, Li J, Leary M, Shea JA, Kirkpatrick JN, Berg RA, Nadkarni VM, Groeneveld PW, Abella BS; CHIP Study Group*. Video-Only Cardiopulmonary Resuscitation Education for High-Risk Families Before Hospital Discharge: A Multicenter Pragmatic Trial. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):740-748. doi: 10.1161/CIRCOUTCOMES.116.002493. Epub 2016 Oct 4.
PubMed 27703033
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-based CPR Training for At-risk Family Members Using a Video-self Instruction Kit or Video-only
- ClinicalTrials.gov ID
- NCT01514656
- Acronym / sponsor ID
- CRS- 814676
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,870 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 23 Jan 2012 (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.
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 education methods (video-only and video self-instruction (VSI) kit).
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 UPHS and local area hospitals to develop local implementation approaches, using either volunteers or nursing staff as training proctors. These stakeholders will be studied as a research subset. The training proctors will train family members or friends of patients at risk for cardiac arrest using either a video-only method or video self-instruction (VSI) kit, and empower them with the lifesaving skill of CPR. The investigators will use the American Heart Association's CPR Anytime VSI kit which comes equip with a DVD and inflatable manikin. For the group receiving the video-only method, the investigators will remove the inflatable manikin and train the subjects with the DVD. The investigators will randomize family members of high risk for CA to either the video-only or VSI kit method of training. The training proctors will be instructed to switch training methods every 6 months. The investigators will follow up with the study subjects and conduct CPR skills tests from 6 to 12 months from 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 the subjects to refresh their training skills. At the follow-up skills test at 6 to 12 months, we will administer a survey to assess whether the prompting encouraged the subjects to practice their skills.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Video Self-Instruction (VSI) kit | Active comparator | Other: CPR Training using the Family and Friends CPR Anytime Video Self InstructionIndividuals will learn CPR using American Heart Association's Video Self-Instruction kit. Main data points being collected at various increments over 12 months are: 1) CPR quality at 6 to 12 months 2) Comfort Level using the skills they learned |
| Video-only | Experimental | Other: CPR Training using the Family and Friends CPR Anytime Video Self InstructionIndividuals will learn CPR skills using a Video training method. Main data points being collected at various increments over 12 months are: 1) CPR Skills at 6 to 12 months 2) Comfort Level with using CPR |
| Recruitment with Volunteers | Active comparator | Other: Implementation of a Hospital-based CPR Training ModelVolunteer subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals. |
| Recruitment with Nurses | Active comparator | Other: Implementation of a Hospital-based CPR Training ModelNurse subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals. |
| Prompting to practice skills | Active comparator | Other: Follow-up prompting to encourage skill retentionIndividuals will be prompted every two months and encouraged to practice the skills that they learned. Main data points being collected at various increments over 12 months are: 1) Comfort Level with using CPR 2) CPR Skills at 6 to 12 months. |
| No prompting to practice skills | Active comparator | Other: Follow-up prompting to encourage skill retentionIndividuals will not be prompted to practice skills. Main data points being collected at various increments over 12 months are: 1) Comfort Level with using CPR 2) CPR Skills at 6 to 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Family Members of Patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.
Key exclusion criteria (1 listed)
- If someone is physically unable to undergo CPR Training
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 |
|---|---|---|
| CPR Training using the Family and Friends CPR Anytime Video Self InstructionSubjects will be trained using the American Heart Association's Family and Friends CPR Anytime Program. The subject's will undergo training in-hospital then they will be encouraged to take the training materials home with them to practice CPR with their family members and friends. | Other | Video Self-Instruction (VSI) kit, Video-only |
| Implementation of a Hospital-based CPR Training ModelNurses and Volunteers will be trained in the hospital-based CPR Training Model, and be encouraged to implement the training program in their respective hospitals. | Other | Recruitment with Nurses, Recruitment with Volunteers |
| Follow-up prompting to encourage skill retentionSubjects will be contacted every two months and encouraged to practice the skills that they have learned. Means of contact include: a) email b) text blasts c) phone calls d) social media e) mail | Other | No prompting to practice skills, Prompting to practice skills |
Primary outcome
CPR Skills Performance and Retention
Time frame: 6 months
To assess skills performance and retention by trainees (family members and friends) taught using a video-only method or video self-instruction kit. To assess whether prompting or reminding subjects (family members and friends) might encourage the subjects to practice their CPR skills and improve skills at time of testing. Subjects skills will be tested at 6 and 12 months period of time.
2 secondary outcomes
Assessing CPR Training Proctors (Nurses or Volunteers)
Time frame: At 3 months, 6 months, 9 months and 12 months
Assess prompting to encourage CPR skills retention
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 21916007Blewer 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.
- Background: PubMed 22080629Blewer 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.
- Derived from this study: PubMed 27703033Blewer AL, Putt ME, Becker LB, Riegel BJ, Li J, Leary M, Shea JA, Kirkpatrick JN, Berg RA, Nadkarni VM, Groeneveld PW, Abella BS; CHIP Study Group*. Video-Only Cardiopulmonary Resuscitation Education for High-Risk Families Before Hospital Discharge: A Multicenter Pragmatic Trial. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):740-748. doi: 10.1161/CIRCOUTCOMES.116.002493. Epub 2016 Oct 4.
- Individual participant dataSharing planned: No
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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.
Benjamin S. Abella, MD, MPhil principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPR Training using the Family and Friends CPR Anytime Video Self Instruction, Implementation of a Hospital-based CPR Training Model and Follow-up prompting to encourage skill retention in people with Cardiovascular Risk Factors and Coronary Disease, run by University of Pennsylvania at 3 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 1 inclusion and 1 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
CPR Skills Performance and Retention (time frame: 6 months). 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 NCT01514656, which also lists 3 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 24 May 2023.