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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
Select...
I am currently taking immediate-release tacrolimus and mycophenolate mofetil.
Select...
I have received a kidney or kidney/pancreas transplant.

Timeline

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

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,810 Previous Clinical Trials
6,385,090 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
~6 spots leftby Jun 2025
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