Kidney TransplantationKIDNEYTIMENCT04285203
Living Donation and Kidney Transplantation Information
A study testing Educational Video Intervention in people with Kidney Transplantation, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to increase awareness and knowledge regarding the risks and benefits of kidney transplantation and living donation amongst patients seeking kidney transplantation and their family and friends in Buffalo, New York. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Educational Video Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 10 Feb 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be 18 years or older,
- understand and read English (or have a support person that helps them)
- have acceptable vision to watch videos
- be able to give consent
Who cannot join
- incarcerated
- involved in the former modeling phase of animation development.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Living Donation and Kidney Transplantation Information Made Easy (KIDNEYTIME) With Animated Video Education
The purpose of this study is to increase awareness and knowledge regarding the risks and benefits of kidney transplantation and living donation amongst patients seeking kidney transplantation and their family and friends in Buffalo, New York.
Read the detailed description
This prospective randomized parallel controlled trial of kidney transplant candidates receiving and educational intervention and standard of care education versus standard of care education only to improve informed decision making about kidney offers.
- Conditions
- Kidney Transplantation
- Being tested
- Educational Video Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Video InterventionOther
Educational videos
| Study group | Role | What they receive |
|---|---|---|
| Educational Video | Experimental | Participants were exposed to 2 educational videos in addition to standard of care education. Receives: Other: Educational Video Intervention |
| Standard of Care | No intervention | Participants received standard of care education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge
Assessed by knowledge survey pre and post exposure.
Measured: Baseline and immediately post exposure
Change in attitude about kidney offers
Assessed by attitude survey pre and post exposure.
Measured: Baseline and immediately post exposure
Secondary outcomes (2)
Change in subjective decisional self-efficacy
Assessed by self-efficacy survey pre and post exposure.
Measured: Baseline and immediately post exposure
Participation and decision making
Number of questions and value statements in regards to organ offers.
Measured: 1 day (During standard of care education at time of clinic visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start8 Apr 2019
- Primary completion29 Aug 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liise Kayler, State University of New York at Buffalo
- Investigators
- Liise Kayler, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285203
- Sponsor's protocol ID
- STUDY00002771
- Acronym
- KIDNEYTIME
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 26 Feb 2020
- 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 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Donation and Kidney Transplantation Information Made Easy (KIDNEYTIME) With Animated Video Education
- ClinicalTrials.gov ID
- NCT04285203
- Acronym / sponsor ID
- KIDNEYTIME / STUDY00002771
- Conditions
- Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 26 Feb 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.
The purpose of this study is to increase awareness and knowledge regarding the risks and benefits of kidney transplantation and living donation amongst patients seeking kidney transplantation and their family and friends in Buffalo, New York.
Detailed description
This prospective randomized parallel controlled trial of kidney transplant candidates receiving and educational intervention and standard of care education versus standard of care education only to improve informed decision making about kidney offers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Video | Experimental | Other: Educational Video InterventionParticipants were exposed to 2 educational videos in addition to standard of care education. |
| Standard of Care | No intervention | –Participants received standard of care education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be 18 years or older,
- understand and read English (or have a support person that helps them)
- have acceptable vision to watch videos
- be able to give consent
Key exclusion criteria (2 listed)
- incarcerated
- involved in the former modeling phase of animation development.
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 |
|---|---|---|
| Educational Video InterventionEducational videos | Other | Educational Video |
Primary outcome
Change in knowledge
Time frame: Baseline and immediately post exposure
Assessed by knowledge survey pre and post exposure.
Change in attitude about kidney offers
Time frame: Baseline and immediately post exposure
Assessed by attitude survey pre and post exposure.
2 secondary outcomes
Change in subjective decisional self-efficacy
Time frame: Baseline and immediately post exposure
Participation and decision making
Time frame: 1 day (During standard of care education at time of clinic visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No
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Hypothermic Kidney Machine Perfusion With Omnisol
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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.
Liise Kayler, MD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video Intervention in people with Kidney Transplantation, run by State University of New York at Buffalo 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 4 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: finished, as of the sponsor's last update on 26 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in knowledge (time frame: Baseline and immediately post exposure). The study lists 2 primary outcomes in all. 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 26 Feb 2020.