Duke Transplant University

Study Overview
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Brief Summary
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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
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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.

Official Title
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Duke Transplant University: A Digital Patient Education Portal

Conditions
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Kidney Transplant; Complications, Patient Empowerment, Medication Adherence, Patient Satisfaction

Intervention / Treatment
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* Behavioral: SOC + Educational Videos Designed Especially for post-transplant patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: recent kidney transplant recipients competent with the capacity to give legal written consent Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized 1:1 to either receive intervention (usual care + videos) or no intervention (usual care only.)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: SOC only patient education post- kidney transplant<br>Participants in this group will receive only SOC patient education following kidney transplant | |
| Experimental: SOC + Videos for patient education post-kidney transplant<br>Participants in this group receive SOC patient education following kidney transplant and access to educational videos designed specifically for post-kidney transplant patients. | Behavioral: SOC + Educational Videos Designed Especially for post-transplant patients<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 1 month, 2 months and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient education post-kidney transplant