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Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This questionnaire has five different domains (physical, social, emotional, cognitive thinking and spiritual/well-being)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a guide to help patients know what to expect after getting a ventricular assist device (VAD), a pump that helps the heart move blood. The guide covers common concerns and sources of satisfaction at different times after surgery. The study is for adults scheduled for VAD surgery and VAD care team members who will review the guide.

There are a variety of educational documents available to help in a participant's decision for VAD implant, however there is little information available to potential participants to help understand areas of satisfaction and concern following a VAD implant as various time points. The investigators want to provide better patient care through increased education and awareness beyond surgical outcomes and contribute to patient understanding of "what to expect" following a VAD implant. The investigators have created an anticipatory guidance (AG) tool based upon previous responses recorded in a local program's database, from the Quality of Life with a Left Ventricular Assist Device (QoLVAD) questionnaire. This questionnaire has five different domains (physical, social, emotional, cognitive thinking and spiritual/well-being). Investigators have previously analyzed responses to determine common areas of satisfaction and concern at 3-, 6-, 12- and 24-months post-VAD implant to better understand quality of life when living with a VAD. Investigators have had both VAD clinicians and VAD patients initially evaluate the tool to determine accuracy and effectiveness of the anticipatory guidance (AG) tool.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must be scheduled for surgery to get a VAD.
  • Patients must speak English because the guide is only available in English.
  • Patients must be age 19 or older when they get the VAD.
  • People reviewing the guide as health care providers must be VAD care team members.

Who can't join

  • Patients who are not scheduled for VAD surgery.
  • Patients who do not speak English.
  • Patients younger than 19.
  • People who are not VAD care team members cannot take part in the health care provider review.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: (For patient inclusion): * scheduled for a VAD implantation * English-speaking as the VAD AG Tool v5.0 has not yet been translated beyond English age ≥19 years at the time of implant as most states in North America have an age of majority for consent signing. (-VAD clinician for the clinician evaluation process) Exclusion Criteria: * Not scheduled for VAD surgery * Non English speaking * \<19 yrs of age (Not a VAD Clinician for the clinician evaluation process)

Study sites (2)

NE

WI