← Back to Search

Other

Immunization App for Transplant Candidates

Q: Is the recruitment process currently active for this trial?

<p>According to clinicaltrials.gov, the trial kick-started on January 1st 2022 and has been recently updated on October 10th of the same year. As such, it is currently searching for volunteers.</p>

Q: What is the participant capacity for this clinical trial?

<p>Affirmative. According to clinicaltrials.gov, this medical research project was posted on January 1st and has been actively recruiting since then, with the most recent update occurring on October 10th. To date they have secured 45 participants from a single site.</p>

N/A

Recruiting

Led By Amy Feldman, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parent, primary care provider and sub-specialist of a child awaiting heart, liver or kidney transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of transplantation (up to 3 years post-enrollment)

Awards & highlights

Study Summary

This trial is testing a new tool to help improve immunization rates for kids who are getting solid organ transplants.

Who is the study for?

This trial is for parents, primary care providers, and sub-specialists of children waiting for a heart, liver, or kidney transplant. Participants must speak English and have access to a smartphone or computer.Check my eligibility

What is being tested?

The study is testing an immunization app designed to increase vaccination rates in pediatric solid organ transplant candidates to prevent infections post-transplant.See study design

What are the potential side effects?

Since the intervention involves using an app rather than medication, there are no direct medical side effects. However, users may experience technical issues or stress related to technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am the parent or caregiver of a child waiting for a heart, liver, or kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of transplantation (up to 3 years post-enrollment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of transplantation (up to 3 years post-enrollment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of transplantation (up to 3 years post-enrollment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effectiveness of Transplant Immunization Tool, as measured by number of patients with up-to-date vaccinations

Secondary outcome measures

Acceptability and Feasibility of the Transplant Immunization Tool, as assessed by a questionnaire

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592

27%

Injection site pain

25%

Pyrexia

14%

Decreased appetite

14%

Upper respiratory tract infection

14%

Diarrhea

10%

Injection site erythema

Nasopharyngitis

Irritability postvaccinal

Headache

Vomiting

Injection site induration

Myalgia

Hypersomnia

Injection site swelling

Fatigue

Crying

Injection site hemorrhage

Gastroenteritis

Pneumonia

Animal Bite

100%

80%

60%

40%

20%

Study treatment Arm

ATIV (6 to <72 Months)

TIV (6 to <72 Months)

Comparator TIV (6 to <72 Months)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Immunization Tool UsersExperimental Treatment1 Intervention

Users will trial a novel transplant-specific immunization tool (app)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,735 Previous Clinical Trials

2,149,126 Total Patients Enrolled

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,822,303 Total Patients Enrolled

Amy Feldman, MDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

Media Library

Immunization App (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04336735 — N/A

Transplant Infection Research Study Groups: Immunization Tool Users

Transplant Infection Clinical Trial 2023: Immunization App Highlights & Side Effects. Trial Name: NCT04336735 — N/A

Immunization App (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04336735 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment process currently active for this trial?

"According to clinicaltrials.gov, the trial kick-started on January 1st 2022 and has been recently updated on October 10th of the same year. As such, it is currently searching for volunteers."

Answered by AI

What is the participant capacity for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical research project was posted on January 1st and has been actively recruiting since then, with the most recent update occurring on October 10th. To date they have secured 45 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Immunization Rates in Transplant Candidates Through the Use of a Health Information Technology Tool

2022. "Improving Immunization Rates in Transplant Candidates Through the Use of a Health Information Technology Tool". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04336735.