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OpenTrials
Completed

NCT Number: NCT04219839

Duke Transplant University

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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

    Time frame: Baseline to 3 months

    Change will be measured by comparing the scores from the Transplant Knowledge assessments completed at baseline and 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

    Time frame: Baseline to 3 months

    Change will be measured by comparing the scores from the Self-Efficacy and Resiliency assessments completed at baseline and 3 months.

  3. Number of medication errors made post-transplant as measured by pillbox errors

    Time frame: 1 month, 2 months and 3 months

    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.

Secondary outcomes

  1. Patients' satisfaction with the transplant experience as measured by satisfaction ratings

    Time frame: Baseline and 6 months

    Patients' satisfaction with the transplant experience will be measured by the rating scores from "general satisfaction" metrics.

  2. Number of hospital re-admissions post transplant

    Time frame: Baseline to 6 months

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Haller Foundation

Registry information

Official study title

Duke Transplant University: A Digital Patient Education Portal

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2020
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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