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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

Must not have

History of multi-organ transplant (other than pancreas)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Select...

I have received a kidney or kidney/pancreas transplant.

Exclusion Criteria

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

Select...

I have had a transplant of multiple organs, not including the pancreas.

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

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

Primary study objectives

Successful home-based therapeutic drug monitoring

Secondary study objectives

Bioanalytical assay agreement for mycophenolic acid

Bioanalytical assay agreement for tacrolimus

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: 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 / 3Eligibility criteria met