Duke Transplant University

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence; Patient Satisfaction; Kidney Transplant; Complications; Patient Empowerment
• Intervention / Treatment: Behavioral: SOC + Educational Videos Designed Especially for post-transplant patients

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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: SOC only patient education post- kidney transplant; Participants in this group will receive only SOC patient education following kidney transplant
Experimental: SOC + Videos for patient education post-kidney transplant; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Haller Foundation
• Investigators: Principal Investigator: John K Roberts, M.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: patient education post-kidney transplant
• Other Study ID Numbers: PRO00102663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No