Duke Transplant University

NCT04219839 | Completed

• 1 other identifier: PRO00102663
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

patient education post-kidney transplant

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Patients' satisfaction with the transplant experience as measured by satisfaction ratings

  Baseline and 6 months

• Number of hospital re-admissions post transplant

  Baseline to 6 months

Study Arms (2)

SOC only patient education post- kidney transplant

NO INTERVENTION

Participants in this group will receive only SOC patient education following kidney transplant

SOC + Videos for patient education post-kidney transplant

EXPERIMENTAL

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

SOC + Educational Videos Designed Especially for post-transplant patients BEHAVIORAL

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).

SOC + Videos for patient education post-kidney transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Haller Foundation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Patient Participation; Medication Adherence; Patient Satisfaction

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Compliance

Study Officials

• John K Roberts, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 to either receive intervention (usual care + videos) or no intervention (usual care only.)

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: November 23, 2020
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: April 19, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)