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CompletedNCT04219839Updated Apr 19, 2022

Duke Transplant University

An interventional study of SOC + Educational Videos Designed Especially for post-transplant patients in Kidney Transplant; Complications, Patient Empowerment and Medication Adherence, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.

Sponsored by Duke University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Kidney Transplant; Complications
  • Patient Empowerment
  • Medication Adherence
  • Patient Satisfaction

Keywords

  • patient education post-kidney transplant
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • recent kidney transplant recipients
  • competent with the capacity to give legal written consent

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
83 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralSOC + 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 3 months

  2. 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.

    Time frame: Baseline to 3 months

  3. 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.

    Time frame: 1 month, 2 months and 3 months

Secondary outcomes

  1. 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.

    Time frame: Baseline and 6 months

  2. Number of hospital re-admissions post transplant

    Hospital re-admissions will be collected from patient report and review of electronic medical record

    Time frame: Baseline to 6 months

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04219839
Lead sponsor
Duke University
Collaborators
Haller Foundation
Responsible party
Sponsor
First posted
Jan 7, 2020
Start date
Nov 23, 2020
Primary completion
Dec 13, 2021
Completion
Dec 13, 2021
Last update
Apr 19, 2022

Study contacts

John K Roberts, M.D.
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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