Transplant PatientsEarly Phase 1NCT02828605
Virtual Interactive Platform (VIP) Transplant Research Study
A Early Phase 1 study testing Virtual Interactive Platform (VIP) Transplant in people with Transplant Patients, run by Yale University.
Trial summary
The purpose of this study is to test a tablet-based application called VIP Transplant, devised to improve the recovery experience of patients that have recently had organ transplant surgery. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplant Patients
- What is being tested?
- Virtual Interactive Platform (VIP) Transplant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2016to 30 Dec 2016
- Phase
- Early Phase 1
- 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 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Willing to participate
- Familiarity with English
- Familiarity with iPad usage/technologically adept
Who cannot join
None listed.
About this study
The purpose of this study is to test a tablet-based application called VIP Transplant, devised to improve the recovery experience of patients that have recently had organ transplant surgery. The study will consist of two non-randomized arms: the first arm will consist of usual care and the second will be using the newly developed app for 21 days to replace their in-person visits. Using questionnaires and in-app usage metrics, the research team will track whether patients have a better medical outcome, greater patient satisfaction with care, and greater compliance rates as compared to patients who do not use VIP Transplant to manage their care.
Read the detailed description
An organ transplant requires a large time and financial investment for both the patient and provider over the course of a lifetime of follow-up visits and lifestyle monitoring. Patients return to the clinic 2-3 times a week for the first three months after surgery, and then visit the clinic twice a month with labs once a week 91-210 days post surgery. Check-ins for patients without complications occur 1-2 times a year, and these re-evaluations require patients to take time off work and travel to the transplant center often 2 hours away. Dr. David Mulligan, Chief of Transplant at Yale wanted to help patients reduce the time and cost associated with their regular checkups after surgery. Thus, we created VIP Transplant. The Virtual Interactive Platform allows patients to have a secure videoconference with their provider in order to eliminate the need for recurring travel and waiting in congested clinics for a short appointment. It will save patient time and cost to travel to the clinic. The application is integrated into the provider network in order to have a system that supports seamless communication between the patient and provider capabilities.
Research plan:
Dr. Mulligan will contact 8 of his patients who are willing to participate in the study. 4 of the patients will be assigned to the control group and the other 4 will be assigned to the experimental group.
Control group:
On day 1 after their surgery, patient will be asked to fill out a survey on their transplant care. On day 21, patient will be asked to fill out the same survey. The surgeon will be asked to take a survey to evaluate their each patient's progress.
Experimental group:
When the 4 patients attend orientation, patient will each be given the iPad with the VIP Transplant app and shown how to use the app. Patient will then be asked to fill out the survey on day 1 after their surgery and then asked to use VIP Transplant for their transplant care in the following days. Patient will then be asked to fill out the survey again on day 21, at the end of the study. The surgeon will be asked to take a survey to evaluate each of their patient's progress.
- Conditions
- Transplant Patients
- Being tested
- Virtual Interactive Platform (VIP) Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Interactive Platform (VIP) TransplantDevice
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Only receive surveys. |
| Experimental Group | Experimental | Receive VIP Transplant App and surveys. Receives: Device: Virtual Interactive Platform (VIP) Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to travel from home to Yale New Haven Hospital
Questionnaire, Scales of 1 to 10
Measured: 30 days
Cost to travel from home to Yale New Haven Hospital
Questionnaire, Scales of 1 to 10
Measured: 30 days
Patient Satisfaction with Care
Questionnaire, Scales of 1 to 10
Measured: 30 days
Physician Satisfaction with Care
Questionnaire, Scales of 1 to 10
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start15 Jul 2016
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant PatientsStudies of the same condition, open and under way.
- More trials run by Yale 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828605
- Sponsor's protocol ID
- 1607018023
- Status last verified
- Sep 2020
- First submitted
- 7 Jul 2016
- Last updated
- 28 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Interactive Platform (VIP) Transplant Research Study
- ClinicalTrials.gov ID
- NCT02828605
- Acronym / sponsor ID
- 1607018023
- Conditions
- Transplant Patients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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 test a tablet-based application called VIP Transplant, devised to improve the recovery experience of patients that have recently had organ transplant surgery. The study will consist of two non-randomized arms: the first arm will consist of usual care and the second will be using the newly developed app for 21 days to replace their in-person visits. Using questionnaires and in-app usage metrics, the research team will track whether patients have a better medical outcome, greater patient satisfaction with care, and greater compliance rates as compared to patients who do not use VIP Transplant to manage their care.
Detailed description
An organ transplant requires a large time and financial investment for both the patient and provider over the course of a lifetime of follow-up visits and lifestyle monitoring. Patients return to the clinic 2-3 times a week for the first three months after surgery, and then visit the clinic twice a month with labs once a week 91-210 days post surgery. Check-ins for patients without complications occur 1-2 times a year, and these re-evaluations require patients to take time off work and travel to the transplant center often 2 hours away. Dr. David Mulligan, Chief of Transplant at Yale wanted to help patients reduce the time and cost associated with their regular checkups after surgery. Thus, we created VIP Transplant. The Virtual Interactive Platform allows patients to have a secure videoconference with their provider in order to eliminate the need for recurring travel and waiting in congested clinics for a short appointment. It will save patient time and cost to travel to the clinic. The application is integrated into the provider network in order to have a system that supports seamless communication between the patient and provider capabilities.
Research plan:
Dr. Mulligan will contact 8 of his patients who are willing to participate in the study. 4 of the patients will be assigned to the control group and the other 4 will be assigned to the experimental group.
Control group:
On day 1 after their surgery, patient will be asked to fill out a survey on their transplant care. On day 21, patient will be asked to fill out the same survey. The surgeon will be asked to take a survey to evaluate their each patient's progress.
Experimental group:
When the 4 patients attend orientation, patient will each be given the iPad with the VIP Transplant app and shown how to use the app. Patient will then be asked to fill out the survey on day 1 after their surgery and then asked to use VIP Transplant for their transplant care in the following days. Patient will then be asked to fill out the survey again on day 21, at the end of the study. The surgeon will be asked to take a survey to evaluate each of their patient's progress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Only receive surveys. |
| Experimental Group | Experimental | Device: Virtual Interactive Platform (VIP) TransplantReceive VIP Transplant App and surveys. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to participate
- Familiarity with English
- Familiarity with iPad usage/technologically adept
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Virtual Interactive Platform (VIP) Transplant | Device | Experimental Group |
Primary outcome
Time to travel from home to Yale New Haven Hospital
Time frame: 30 days
Questionnaire, Scales of 1 to 10
Cost to travel from home to Yale New Haven Hospital
Time frame: 30 days
Questionnaire, Scales of 1 to 10
Patient Satisfaction with Care
Time frame: 30 days
Questionnaire, Scales of 1 to 10
Physician Satisfaction with Care
Time frame: 30 days
Questionnaire, Scales of 1 to 10
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 28 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Virtual Interactive Platform (VIP) Transplant in people with Transplant Patients, run by Yale University.
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 3 inclusion and 0 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 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to travel from home to Yale New Haven Hospital (time frame: 30 days). The study lists 4 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 28 Sep 2020.