Duke Transplant University

Medication Adherence Clinical Trial

Official title:

Duke Transplant University: A Digital Patient Education Portal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219839
• Other study ID #: PRO00102663
• Status: Completed
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: December 13, 2021

Study information

• Verified date: October 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Haller Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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