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Behavioral Intervention

mHealth Messaging for Transplant Medication Adherence

N/A

Recruiting

Led By Cyd Eaton, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Currently prescribed tacrolimus or sirolimus

Be younger than 65 years old

Must not have

Currently receiving dialysis

No access to a mobile device that supports text messaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a mobile technology intervention can help young people who have had kidney or liver transplants to remember to take their medication on time. The intervention includes an electronic pillbox and text

Who is the study for?

This trial is for young people aged 13-25 who had a kidney or liver transplant at least 6 months ago and are taking specific anti-rejection drugs (tacrolimus or sirolimus).

What is being tested?

The study tests if a mobile tech intervention with electronic pillbox monitoring and text message reminders can help these patients take their medication on time to prevent organ rejection.

What are the potential side effects?

Since the intervention involves technology use rather than medications, there aren't direct side effects like those from drugs. However, participants may experience stress or anxiety related to adherence notifications.

Eligibility Criteria

Inclusion Criteria

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

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I am currently taking tacrolimus or sirolimus.

Exclusion Criteria

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

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I am currently undergoing dialysis.

Select...

I do not have a mobile device that can send or receive texts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 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

Pharmaceutical Preparations

Secondary study objectives

Standard deviation of antirejection medication dose timing

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mobile health (mHealth) text messaging interventionExperimental Treatment1 Intervention

During baseline (4 weeks), adherence will be monitored daily via electronic pill boxes and no text messages will be sent. After baseline, participants will begin the 12-week micro-randomized trial of the intervention (a within-person study design). During this 12-week micro-randomized trial, daily adherence will be electronically monitored with the electronic pill boxes and participants will be randomized to receive (1) adherence support text messages or (2) no text message after each missed dose, and (1) praise text message or (2) no text message after each on time dose. For 12 months post-intervention, participants will keep using the electronic pill boxes (no text messages will be sent).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mHealth Messaging Intervention Group

2018

N/A

~40

0 / 3Eligibility criteria met