Kidney Transplant; ComplicationsNCT04219839
Duke Transplant University
A study testing SOC + Educational Videos Designed Especially for post-transplant patients in people with Kidney Transplant; Complications and Patient Empowerment, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effectiveness of educational videos for patients who have just had kidney transplant compared to usual patient education practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Patient Empowerment, Medication Adherence
- What is being tested?
- SOC + Educational Videos Designed Especially for post-transplant patients
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2020to 13 Dec 2021
- 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
- recent kidney transplant recipients
- competent with the capacity to give legal written consent
Who cannot join
- Unable to sign informed consent.
- Patients with delirium, dementia, or other cognitive impairment that would not allow informed consent to enter the study.
- patients with severe vision or auditory impairment who are unable to view or hear electronic videos at close range.
- patients who are unable to understand the English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Duke Transplant University: A Digital Patient Education Portal
The purpose of this research study is to determine the effectiveness of educational videos for patients who have just had kidney transplant compared to usual patient education practices. Eligible patients will have the opportunity to enroll in this study after their transplant procedure either before hospital discharge or at their first follow up clinic visit.
Read the detailed description
Participants will then complete a demographic survey and knowledge assesment to establish their baseline of knowledge regarding post-transplant care, medication adherence and patient satisfaction. Participants will then be randomly selected to receive either the usual patient education care provided for patients following kidney transplant, or to receive the usual care plus access to educational videos designed especially for post- transplant patients. Videos can be viewed on a tablet computer with their transplant team during clinic visits and at home using a smartphone.
At 3 months post-transplant, all participants will be asked to repeat the knowledge assessment. Hospital re-admissions and patient satisfaction will be measured at 6 months after transplant.
- Conditions
- Kidney Transplant; Complications, Patient Empowerment, Medication Adherence, Patient Satisfaction
- Being tested
- SOC + Educational Videos Designed Especially for post-transplant patients
- Keywords
- patient education post-kidney transplant
- Medical subject headings
- Patient Participation, Medication Adherence, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOC + Educational Videos Designed Especially for post-transplant patientsBehavioural
Patient focused videos (3-5 minutes each) with topics that will include: What to Expect After Transplant, What is the Kidney, Understanding your Labs, Transplant Medications, General Medical Care Post-Transplant, When to Call your Coordinator, and Self-Management/Sick Day protocols. Video curriculum will be offered in two ways. First, tablet computers with active links to each video will be available in kidney transplant clinic. At provider/coordinator discretion, study participants may also view videos while waiting for other appointments. In addition, for patients with smartphones who consent to this, a desktop link will be provided to the transplant video curriculum webpage (mobile friendly view).
| Study group | Role | What they receive |
|---|---|---|
| SOC only patient education post- kidney transplant | No intervention | Participants in this group will receive only SOC patient education following kidney transplant |
| SOC + Videos for patient education post-kidney transplant | Experimental | Participants in this group receive SOC patient education following kidney transplant and access to educational videos designed specifically for post-kidney transplant patients. Receives: Behavioral: SOC + Educational Videos Designed Especially for post-transplant patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient transplant knowledge during intervention as measured by the scores from the "Transplant Knowledge" block within the Duke Transplant University Assessment
Change will be measured by comparing the scores from the Transplant Knowledge assessments completed at baseline and 3 months.
Measured: Baseline to 3 months
Change in perceptions of self-efficacy as measured by the scores from the "Self-Efficacy and Resiliency" assessment within the Duke Transplant University Assessment
Change will be measured by comparing the scores from the Self-Efficacy and Resiliency assessments completed at baseline and 3 months.
Measured: Baseline to 3 months
Number of medication errors made post-transplant as measured by pillbox errors
The number of medication errors will be measured by counting number of pill box errors identified by pharmacist's review of patient's pillbox during transplant follow up clinic visits conducted at 1 month, 2 months and 3 months.
Measured: 1 month, 2 months and 3 months
Secondary outcomes (2)
Patients' satisfaction with the transplant experience as measured by satisfaction ratings
Patients' satisfaction with the transplant experience will be measured by the rating scores from "general satisfaction" metrics.
Measured: Baseline and 6 months
Number of hospital re-admissions post transplant
Hospital re-admissions will be collected from patient report and review of electronic medical record
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start23 Nov 2020
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Duke 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 to either receive intervention (usual care + videos) or no intervention (usual care only.)
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Haller Foundation
- Responsible party
- Sponsor
- Investigators
- John K Roberts, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219839
- Sponsor's protocol ID
- PRO00102663
- Status last verified
- Oct 2021
- First submitted
- 3 Jan 2020
- Last updated
- 19 Apr 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duke Transplant University: A Digital Patient Education Portal
- ClinicalTrials.gov ID
- NCT04219839
- Acronym / sponsor ID
- PRO00102663
- Conditions
- Kidney Transplant; Complications, Patient Empowerment, Medication Adherence, Patient Satisfaction
- Keywords
- patient education post-kidney transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Haller Foundation
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 7 Jan 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 research study is to determine the effectiveness of educational videos for patients who have just had kidney transplant compared to usual patient education practices. Eligible patients will have the opportunity to enroll in this study after their transplant procedure either before hospital discharge or at their first follow up clinic visit.
Detailed description
Participants will then complete a demographic survey and knowledge assesment to establish their baseline of knowledge regarding post-transplant care, medication adherence and patient satisfaction. Participants will then be randomly selected to receive either the usual patient education care provided for patients following kidney transplant, or to receive the usual care plus access to educational videos designed especially for post- transplant patients. Videos can be viewed on a tablet computer with their transplant team during clinic visits and at home using a smartphone.
At 3 months post-transplant, all participants will be asked to repeat the knowledge assessment. Hospital re-admissions and patient satisfaction will be measured at 6 months after transplant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 to either receive intervention (usual care + videos) or no intervention (usual care only.)
| Arm | Type | Receives |
|---|---|---|
| SOC only patient education post- kidney transplant | No intervention | –Participants in this group will receive only SOC patient education following kidney transplant |
| SOC + Videos for patient education post-kidney transplant | Experimental | Behavioral: SOC + Educational Videos Designed Especially for post-transplant patientsParticipants in this group receive SOC patient education following kidney transplant and access to educational videos designed specifically for post-kidney transplant patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- recent kidney transplant recipients
- competent with the capacity to give legal written consent
Key exclusion criteria (4 listed)
- Unable to sign informed consent.
- Patients with delirium, dementia, or other cognitive impairment that would not allow informed consent to enter the study.
- patients with severe vision or auditory impairment who are unable to view or hear electronic videos at close range.
- patients who are unable to understand the English language.
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 |
|---|---|---|
| SOC + Educational Videos Designed Especially for post-transplant patientsPatient focused videos (3-5 minutes each) with topics that will include: What to Expect After Transplant, What is the Kidney, Understanding your Labs, Transplant Medications, General Medical Care Post-Transplant, When to Call your Coordinator, and Self-Management/Sick Day protocols. Video curriculum will be offered in two ways. First, tablet computers with active links to each video will be available in kidney transplant clinic. At provider/coordinator discretion, study participants may also view videos while waiting for other appointments. In addition, for patients with smartphones who consent to this, a desktop link will be provided to the transplant video curriculum webpage (mobile friendly view). | Behavioural | SOC + Videos for patient education post-kidney transplant |
Primary outcome
Change in patient transplant knowledge during intervention as measured by the scores from the "Transplant Knowledge" block within the Duke Transplant University Assessment
Time frame: Baseline to 3 months
Change will be measured by comparing the scores from the Transplant Knowledge assessments completed at baseline and 3 months.
Change in perceptions of self-efficacy as measured by the scores from the "Self-Efficacy and Resiliency" assessment within the Duke Transplant University Assessment
Time frame: Baseline to 3 months
Change will be measured by comparing the scores from the Self-Efficacy and Resiliency assessments completed at baseline and 3 months.
Number of medication errors made post-transplant as measured by pillbox errors
Time frame: 1 month, 2 months and 3 months
The number of medication errors will be measured by counting number of pill box errors identified by pharmacist's review of patient's pillbox during transplant follow up clinic visits conducted at 1 month, 2 months and 3 months.
2 secondary outcomes
Patients' satisfaction with the transplant experience as measured by satisfaction ratings
Time frame: Baseline and 6 months
Number of hospital re-admissions post transplant
Time frame: Baseline to 6 months
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 19 Apr 2022.
- Individual participant dataSharing planned: No
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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.
John K Roberts, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOC + Educational Videos Designed Especially for post-transplant patients in people with Kidney Transplant; Complications and Patient Empowerment, run by Duke University 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 2 inclusion and 4 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 19 Apr 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?
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 patient transplant knowledge during intervention as measured by the scores from the "Transplant Knowledge" block within the Duke Transplant University Assessment (time frame: Baseline to 3 months). The study lists 3 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 19 Apr 2022.