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CPR Training: Video Self-Instruction Kit or Video-Only

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01514656
First received: December 12, 2011
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention Phase
Cardiovascular Risk Factors
Coronary Disease
Cardiac Arrest
Other: CPR Training using the Family and Friends CPR Anytime Video Self Instruction
Other: Implementation of a Hospital-based CPR Training Model
Other: Follow-up prompting to encourage skill retention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Hospital-based CPR Training for At-risk Family Members Using a Video-self Instruction Kit or Video-only

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • CPR Skills Performance and Retention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Assessing CPR Training Proctors (Nurses or Volunteers) [ Time Frame: At 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
    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.

  • Assess prompting to encourage CPR skills retention [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    To assess whether prompting subjects every two months encourages them to practice and retain the skills that they learned.


Estimated Enrollment: 5000
Study Start Date: November 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Video Self-Instruction (VSI) kit
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
Other: CPR Training using the Family and Friends CPR Anytime Video Self Instruction
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.
Experimental: Video-only
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
Other: CPR Training using the Family and Friends CPR Anytime Video Self Instruction
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.
Active Comparator: Recruitment with Volunteers
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.
Other: Implementation of a Hospital-based CPR Training Model
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.
Active Comparator: Recruitment with Nurses
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.
Other: Implementation of a Hospital-based CPR Training Model
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.
Active Comparator: Prompting to practice skills
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.
Other: Follow-up prompting to encourage skill retention
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
Active Comparator: No prompting to practice skills
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.
Other: Follow-up prompting to encourage skill retention
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Family Members of Patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.

Exclusion Criteria:

  • If someone is physically unable to undergo CPR Training
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514656

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Benjamin S. Abella, MD, MPhil University of Pennsylvania
  More Information

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01514656     History of Changes
Other Study ID Numbers: CRS- 814676
Study First Received: December 12, 2011
Last Updated: January 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Arrest
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014