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Educational Intervention for Kidney Disease (KidneyTIME Trial)

N/A

Waitlist Available

Led By Liise Kayler, MD

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years and older

Referred to the transplant center for a kidney transplant

Must not have

Previously exposed to any component of the intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately post baseline, 1 month, 6 month, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of a patient-based self-learning and outreach intervention about living-donor kidney transplantation (KidneyTIME) versus usual care for living-donor kidney transplant knowledge, concerns, readiness, access behaviors, and living-donor inquiries over 12 months follow-up.

Who is the study for?

This trial is for adults over 18 who speak English, have internet access, and are referred to the transplant center for a kidney transplant. It's not open to those who've already seen parts of the intervention.

What is being tested?

The study compares KidneyTIME—a video-based education and mobile communication tool about living-donor kidney transplants—with usual care. Participants are randomly placed into two groups to see if KidneyTIME improves knowledge and readiness over a year.

What are the potential side effects?

Since this trial focuses on educational interventions rather than medical treatments, there are no direct side effects from drugs or procedures. However, participants may experience stress or anxiety related to learning about their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am referred for a kidney transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a component of the study intervention before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately post baseline, 1 month, 6 month, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately post baseline, 1 month, 6 month, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post baseline, 1 month, 6 month, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Living Donor Inquiry

Secondary study objectives

LDKT Concerns Scale

LDKT Knowledge scale

LDKT Readiness

+1 more

Other study objectives

Time to waiting-list placement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: KidneyTIMEExperimental Treatment1 Intervention

KidneyTIME is a self-directed digital intervention. It contains 26 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. We chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. After completing the proscribed videos and an immediate-post exposure survey, everyone then received a link to access all 26 videos centralized on a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website could be accessed using this link from any electronic device throughout the study. Prompts to use the intervention were sent once a week for 3 weeks and then monthly for 12 months.

Group II: Usual CareActive Control1 Intervention

Routine educational materials from non-study sources through usual Transplant Center protocols including booklets, nurse communications, and the usual care video, a nurse-narrated power-point presentation outlining recipient and donor evaluation, surgery, and recovery processes and outcomes.

0 / 3Eligibility criteria met