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Educational Intervention for Kidney Disease (KidneyTIME Trial)

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post baseline, 1 month, 6 month, and 12 months
Awards & highlights

KidneyTIME Trial 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.Check my eligibility
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.See study design
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.

KidneyTIME Trial 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.

KidneyTIME Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Living Donor Inquiry
Secondary outcome measures
LDKT Concerns Scale
LDKT Knowledge scale
LDKT Readiness
+1 more
Other outcome measures
Time to waiting-list placement

KidneyTIME 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.

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
246 Previous Clinical Trials
49,080 Total Patients Enrolled

Media Library

Kidney donation and transplant information made easy Clinical Trial Eligibility Overview. Trial Name: NCT05154773 — N/A
Kidney Disease Research Study Groups: KidneyTIME, Usual Care
Kidney Disease Clinical Trial 2023: Kidney donation and transplant information made easy Highlights & Side Effects. Trial Name: NCT05154773 — N/A
Kidney donation and transplant information made easy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05154773 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research accepting new recruits?

"Clinicaltrials.gov indicates that this ongoing medical trial began recruiting on April 1st, 2022 and underwent its latest update in May 11th of the same year."

Answered by AI

How many participants are eligible to join this experiment?

"Yes, it appears that the trial is currently recruiting. Originally posted on April 1st 2022 and last updated on May 11th, this medical investigation seeks to enroll 408 individuals across one centre."

Answered by AI
~31 spots leftby Jun 2024