Transplantation InfectionNCT04336735
Improving Immunization Rates in Transplant Candidates Through the Use of a Health Information Technology Tool
A study testing immunization app in people with Transplantation Infection and Vaccination, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Vaccine preventable infections are a serious complication following pediatric solid organ transplant. Immunizations are a minimally invasive and cost-effective was to reduce these infections. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Transplantation Infection, Vaccination
- What is being tested?
- immunization app
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to Aug 2024
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent, primary care provider and sub-specialist of a child awaiting heart, liver or kidney transplant
Who cannot join
- Non English speaking
- No access to a smart phone or computer
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Childrens Hospital Colorado
Aurora, Colorado, 80045
Amy Feldman, MD
About this study
Vaccine preventable infections are a serious complication following pediatric solid organ transplant. Immunizations are a minimally invasive and cost-effective was to reduce these infections. Despite the importance of pre-transplant vaccination, the majority of pediatric solid organ transplant recipients are not up-to-date on age-appropriate immunizations at the time of transplant. The goal of this study is to pilot a novel health information technology immunization tool to improve immunization rates in pediatric solid organ transplant candidates.
Read the detailed description
Triads of parents, primary care physicians, and transplant sub-specialists will be enrolled to use a pre-transplant immunization tool while their child awaits transplant. The tool will provide information about vaccines, information about vaccine-preventable infections in the transplant population, a central easily accessible vaccine record, and a communication portal. The tool will also send vaccine reminders when vaccinations are due. The investigators will assess 1) the effectiveness of the tool in improving pre-transplant immunization rates, 2) the acceptability of the tool to users and 3) the feasibility of the tool.
- Conditions
- Transplantation Infection, Vaccination
- Being tested
- immunization app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunization appOther
A transplant specific immunization app will be trialed that 1) provides vaccine information and education, 2) stores vaccine records and 3) provides reminders when vaccines are due
| Study group | Role | What they receive |
|---|---|---|
| Immunization Tool Users | Experimental | Users will trial a novel transplant-specific immunization tool (app) Receives: Other: immunization app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Transplant Immunization Tool, as measured by number of patients with up-to-date vaccinations
We will assess whether the novel immunization tool improves pre-transplant vaccination rates. The number of participants who are up to date with vaccinations will be reported.
Measured: Date of transplantation (up to 3 years post-enrollment)
Secondary outcomes (1)
Acceptability and Feasibility of the Transplant Immunization Tool, as assessed by a questionnaire
We will assess whether the novel immunization tool is feasible and acceptable to users using a Likert scale with possible scores of 1-5, with 1 being least feasible/acceptable to the participant and 5 being the most feasible/acceptable.
Measured: Date of transplantation (up to 3 years post-enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Jan 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation InfectionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 45 triads of parents, primary care physicians and subspecialists of children awaiting heart, liver and kidney transplantation will be enrolled to use a novel immunization tool (app).
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Amy Feldman, Principal investigator, UCD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336735
- Sponsor's protocol ID
- 20-0527
- Other IDs
- K08HS026510
- Status last verified
- Jan 2022
- First submitted
- 3 Apr 2020
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Immunization Rates in Transplant Candidates Through the Use of a Health Information Technology Tool
- ClinicalTrials.gov ID
- NCT04336735
- Acronym / sponsor ID
- 20-0527
- Conditions
- Transplantation Infection, Vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 7 Apr 2020 (actual)
- 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.
Vaccine preventable infections are a serious complication following pediatric solid organ transplant. Immunizations are a minimally invasive and cost-effective was to reduce these infections. Despite the importance of pre-transplant vaccination, the majority of pediatric solid organ transplant recipients are not up-to-date on age-appropriate immunizations at the time of transplant. The goal of this study is to pilot a novel health information technology immunization tool to improve immunization rates in pediatric solid organ transplant candidates.
Detailed description
Triads of parents, primary care physicians, and transplant sub-specialists will be enrolled to use a pre-transplant immunization tool while their child awaits transplant. The tool will provide information about vaccines, information about vaccine-preventable infections in the transplant population, a central easily accessible vaccine record, and a communication portal. The tool will also send vaccine reminders when vaccinations are due. The investigators will assess 1) the effectiveness of the tool in improving pre-transplant immunization rates, 2) the acceptability of the tool to users and 3) the feasibility of the tool.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 45 triads of parents, primary care physicians and subspecialists of children awaiting heart, liver and kidney transplantation will be enrolled to use a novel immunization tool (app).
| Arm | Type | Receives |
|---|---|---|
| Immunization Tool Users | Experimental | Other: immunization appUsers will trial a novel transplant-specific immunization tool (app) |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parent, primary care provider and sub-specialist of a child awaiting heart, liver or kidney transplant
Key exclusion criteria (2 listed)
- Non English speaking
- No access to a smart phone or computer
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 |
|---|---|---|
| immunization appA transplant specific immunization app will be trialed that 1) provides vaccine information and education, 2) stores vaccine records and 3) provides reminders when vaccines are due | Other | Immunization Tool Users |
Primary outcome
Effectiveness of Transplant Immunization Tool, as measured by number of patients with up-to-date vaccinations
Time frame: Date of transplantation (up to 3 years post-enrollment)
We will assess whether the novel immunization tool improves pre-transplant vaccination rates. The number of participants who are up to date with vaccinations will be reported.
1 secondary outcome
Acceptability and Feasibility of the Transplant Immunization Tool, as assessed by a questionnaire
Time frame: Date of transplantation (up to 3 years post-enrollment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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HIV, Hematologic Malignancies
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.
Amy Feldman principal investigator
UCD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunization app in people with Transplantation Infection and Vaccination, run by University of Colorado, Denver 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Feldman, MD (720-777-5354, amy.feldman@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Transplant Immunization Tool, as measured by number of patients with up-to-date vaccinations (time frame: Date of transplantation (up to 3 years post-enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2022.