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Text Message Reminders for Kidney Transplant Patients

N/A

Waitlist Available

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Receiving immediate-release tacrolimus and mycophenolate mofetil

Recipient of a kidney or kidney/pancreas transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial will test if text messages can help kidney transplant patients remember to take their medication and collect blood samples at home for therapeutic drug monitoring.

Who is the study for?

This trial is for kidney transplant recipients who can read and speak English, are willing to use their mobile device to receive text messages, and consent to the study. They must be taking tacrolimus and mycophenolate mofetil medications and agree to standard lab tests at a Michigan Medicine site twice. Those with multi-organ transplants (besides pancreas) or allergies to tape adhesives cannot participate.Check my eligibility

What is being tested?

The trial is testing if automated text reminders sent to patients' mobile devices can help them better collect blood samples at home for drug monitoring of tacrolimus and mycophenolate. The goal is to see if these reminders improve the quality of self-collected blood samples.See study design

What are the potential side effects?

There may not be direct side effects from receiving text message reminders; however, participants will need to use a lancet device for blood collection which could cause minor discomfort or bruising at the puncture site.

Eligibility Criteria

Inclusion Criteria

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

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I am currently taking immediate-release tacrolimus and mycophenolate mofetil.

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I have received a kidney or kidney/pancreas transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Successful home-based therapeutic drug monitoring

Secondary outcome measures

Bioanalytical assay agreement for mycophenolic acid

Bioanalytical assay agreement for tacrolimus

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bidirectional Text CommunicationExperimental Treatment1 Intervention

Participants in the bidirectional text communication arm will also receive automated messages to remind them to collect blood samples 48 hours before, 12 hours before, and the morning of the planned sample collection but they will be asked to confirm the planned day or reschedule. On the day of sample collection participants will also reply with the time the samples are collected to trigger future reminder messages for each of the 4 samples. N=30

Group II: Unidirectional Text RemindersActive Control1 Intervention

Participants in the unidirectional text reminder arm will receive automated text messages to remind them to collect blood samples 48 hours before, 12 hours before, and the morning of the planned sample collection. N=15

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,796 Previous Clinical Trials

6,377,941 Total Patients Enrolled

Media Library

Automated text messages Clinical Trial Eligibility Overview. Trial Name: NCT05005221 — N/A

Kidney Transplant Research Study Groups: Unidirectional Text Reminders, Bidirectional Text Communication

Kidney Transplant Clinical Trial 2023: Automated text messages Highlights & Side Effects. Trial Name: NCT05005221 — N/A

Automated text messages 2023 Treatment Timeline for Medical Study. Trial Name: NCT05005221 — N/A

Frequently Asked Questions

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

Are adolescents within the accepted age range for participating in this medical study?

"According to the inclusion criteria of this clinical study, eligible participants must be between 18 and 99 years old."

Answered by AI

For which patient demographic is this clinical trial available?

"To qualify to join this medical trial, individuals must possess healthy kidneys and be aged 18-99. A total of 45 patients will be admitted into the study."

Answered by AI

Is recruitment still in progress for this clinical trial?

"Affirmative. Clinicaltrials.gov has the most recent information that this research is currently searching for participants, with a total of 45 individuals needed from one location since its initial posting on November 8th 2022."

Answered by AI

What is the current enrollment capacity for this research?

"Affirmative. Clinicaltrials.gov has made the public aware that this clinical trial seeks 45 participants from 1 site and is still recruiting since its initial posting on November 8th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Home-based Therapeutic Drug Monitoring in Kidney Transplantation

Manjunath Prakash Pai 2022. "Home-based Therapeutic Drug Monitoring in Kidney Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05005221.

All > Kidney Transplant