Heart FailureSimVADNCT03073005

Use of Simulation to Improve VAD Self-management

A study testing Simulation-based Mastery Learning (SBML) in people with Heart Failure, run by Northwestern University at 1 site 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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Heart Failure
What is being tested?: Simulation-based Mastery Learning (SBML)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 143 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2017to 30 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

None listed.

Who cannot join

Vulnerable populations of patients will not be included in this study (including fetuses, neonates, children, pregnant women, prisoners, mentally retarded or incompetent individuals, institutionalized individuals, or individuals unable to give consent due to their medical condition). Fetuses and neonates are not the focus of our study.
Pregnant women will not be included since pregnancy is a contraindication to VAD implantation It is possible that VAD caregivers may be pregnant at the time of the study.
Patients with mental retardation, mental incompetence, or patients who are unable to give consent due to their medical condition will not be included as they will not be able to complete measures.
Lastly, institutionalized individuals will not be included as access will be a problem, and these individuals are rarely referred for VAD implantation

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Use of Simulation to Improve Ventricular Assist Device Self-management

This study will evaluate the performance of a curriculum using medical simulators to train patients with advanced heart failure and their caregivers to master the self-management of ventricular assist devices (a device implanted into the heart to help circulate the blood). The investigators expect this training will improve self-management skills, and reduce VAD-related infections and re-hospitalizations. In addition to providing innovative training to the patients and their caregivers, the study will advance our knowledge of the effects of simulation-based training on patient self-management and safety.

Conditions: Heart Failure
Being tested: Simulation-based Mastery Learning (SBML)
Keywords: ventricular assist device (VAD), heart failure, simulation
Medical subject headings: Heart Failure

What participants receive

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

Simulation-based Mastery Learning (SBML)Other
The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.

Study groups in NCT03073005
Study group	Role	What they receive
Traditional VAD training	No intervention	Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
Simulation-based VAD training	Experimental	Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management Receives: Other: Simulation-based Mastery Learning (SBML)

What is being measured

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

Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups
The investigators will compare the performance of the SBML intervention group to the usual VAD training group during actual VAD care activities (controller change, power source change and dressing change) plus a written examination. Only caregivers were assessed on dressing change as patients do not independently complete this task.
Measured: 3 months

Secondary outcomes (3)

Infections and Re-hospitalizations up to 3 Months After VAD Implant
All VAD related driveline infections and re-hospitalizations between the SBML intervention group as compared to the usual VAD training group
Measured: 3 months after discharge
Self-management Skill Decay in the Five Domains
The investigators will measure the change in skill decay on the patient from 0 (time of implant), one and three months using VAD self-management checklists (controller change, power source change and dressing change) throughout the study period.
Measured: 1 month and 3 months after discharge (*1 month SBML-trained only)
Comparisons of Self-confidence Between Groups
Simulation-based Mastery Learning (SBML) Trained and Usual Trained Patient and Caregiver Reported Self-Confidence (0=very low confidence to 100=very high confidence) before Discharge Testing on Five VAD Skills.
Measured: 3 months

Timeline

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

1 Jun 201730 Oct 2019

First posted8 Mar 2017
Study start1 Jun 2017
Primary completion30 Oct 2019
Study completion30 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03073005
Sponsor's protocol ID: STU00203530
Other IDs: 5R21NR016745-02
Acronym: SimVAD
Status last verified: May 2021
First submitted: 20 Feb 2017
Last updated: 10 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Barsuk JH, Wilcox JE, Cohen ER, Harap RS, Shanklin KB, Grady KL, Kim JS, Nonog GP, Schulze LE, Jirak AM, Wayne DB, Cameron KA. Simulation-Based Mastery Learning Improves Patient and Caregiver Ventricular Assist Device Self-Care Skills: A Randomized Pilot Trial. Circ Cardiovasc Qual Outcomes. 2019 Oct;12(10):e005794. doi: 10.1161/CIRCOUTCOMES.119.005794. Epub 2019 Oct 11.
PubMed 31601111

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Simulation to Improve Ventricular Assist Device Self-management
ClinicalTrials.gov ID: NCT03073005
Acronym / sponsor ID: SimVAD / STU00203530
Conditions: Heart Failure
Keywords: ventricular assist device (VAD), heart failure, simulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 1 Jun 2017 (actual)
Primary completion: 30 Oct 2019 (actual)
Study completion: 30 Oct 2019 (actual)
First posted: 8 Mar 2017 (actual)
Results: Posted 10 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Traditional VAD training	No intervention	–Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
Simulation-based VAD training	Experimental	Other: Simulation-based Mastery Learning (SBML)Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (4 listed)

Vulnerable populations of patients will not be included in this study (including fetuses, neonates, children, pregnant women, prisoners, mentally retarded or incompetent individuals, institutionalized individuals, or individuals unable to give consent due to their medical condition). Fetuses and neonates are not the focus of our study.
Pregnant women will not be included since pregnancy is a contraindication to VAD implantation It is possible that VAD caregivers may be pregnant at the time of the study.
Patients with mental retardation, mental incompetence, or patients who are unable to give consent due to their medical condition will not be included as they will not be able to complete measures.
Lastly, institutionalized individuals will not be included as access will be a problem, and these individuals are rarely referred for VAD implantation

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
Simulation-based Mastery Learning (SBML)The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.	Other	Simulation-based VAD training

Primary outcome

Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups
Time frame: 3 months
The investigators will compare the performance of the SBML intervention group to the usual VAD training group during actual VAD care activities (controller change, power source change and dressing change) plus a written examination. Only caregivers were assessed on dressing change as patients do not independently complete this task.

3 secondary outcomes

Infections and Re-hospitalizations up to 3 Months After VAD Implant
Time frame: 3 months after discharge
Self-management Skill Decay in the Five Domains
Time frame: 1 month and 3 months after discharge (*1 month SBML-trained only)
Comparisons of Self-confidence Between Groups
Time frame: 3 months

Results and safety

Results posted to the registry on 10 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Traditional VAD Training (Patients)	33	25
Traditional VAD Training (Caregivers)	37	25
Simulation-based VAD Training (Patients)	36	24
Simulation-based VAD Training (Caregivers)	37	24

Primary outcome: Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups

Time frame: 3 months. Median (Inter-Quartile Range). Unit: percentage of checklist items correct

Measure	Traditional VAD Training (Patients) n = 25	Traditional VAD Training (Caregivers) n = 25	Simulation-based VAD Training (Patients) n = 24	Simulation-based VAD Training (Caregivers) n = 24
Written examination	100 (97.1 to 100)	97.1 (97.1 to 100)	100 (97.1 to 100)	100 (97.1 to 100)
Controller change	92.9 (78.6 to 100)	100 (100 to 100)	100 (100 to 100)	100 (100 to 100)
Power source change	88.9 (88.9 to 88.9)	88.9 (88.9 to 96.2)	100 (100 to 100)	100 (100 to 100)
Dressing change	–	81.3 (68.8 to 87.5)	–	100 (100 to 100)

Population analysed: Patient and caregiver pairs were included if both the patient and their caregiver completed training and assessments through discharge testing. (\*Note- Only caregivers were assessed on dressing change as patients do not independently complete this task.)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year post patient discharge. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Traditional VAD Training (Patients)	0 of 33 (0%)	0 of 33 (0%)	10 of 33
Simulation-based VAD Training (Patients)	0 of 36 (0%)	0 of 36 (0%)	10 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31601111Barsuk JH, Wilcox JE, Cohen ER, Harap RS, Shanklin KB, Grady KL, Kim JS, Nonog GP, Schulze LE, Jirak AM, Wayne DB, Cameron KA. Simulation-Based Mastery Learning Improves Patient and Caregiver Ventricular Assist Device Self-Care Skills: A Randomized Pilot Trial. Circ Cardiovasc Qual Outcomes. 2019 Oct;12(10):e005794. doi: 10.1161/CIRCOUTCOMES.119.005794. Epub 2019 Oct 11.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction

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.

Jeffrey Barsuk, MD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Simulation-based Mastery Learning (SBML) in people with Heart Failure, run by Northwestern University at 1 site 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 0 inclusion and 4 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups (time frame: 3 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 NCT03073005, which also lists 1 linked publication.

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 10 May 2021; AzTrials last refreshed its copy on 31 Oct 2026.