Clinical trial NCT04219839: Duke Transplant University
Official title: Duke Transplant University: A Digital Patient Education Portal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant; Complications
Patient Empowerment
Medication Adherence
Patient Satisfaction
Keywords: patient education post-kidney transplant
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Haller Foundation
First posted: 2020-01-07
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 to either receive intervention (usual care + videos) or no intervention (usual care only.)
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in patient transplant knowledge during intervention as measured by the scores from the "Transplant Knowledge" block within the Duke Transplant University Assessment
timeFrame: Baseline to 3 months
measure: Change in perceptions of self-efficacy as measured by the scores from the "Self-Efficacy and Resiliency" assessment within the Duke Transplant University Assessment
timeFrame: Baseline to 3 months
measure: Number of medication errors made post-transplant as measured by pillbox errors
timeFrame: 1 month, 2 months and 3 months
Secondary outcomes:
measure: Patients' satisfaction with the transplant experience as measured by satisfaction ratings
timeFrame: Baseline and 6 months
measure: Number of hospital re-admissions post transplant
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John K Roberts, M.D.
role: PRINCIPAL_INVESTIGATOR
References: