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Behavioral Intervention

Mobile health (mHealth) text messaging intervention for Kidney Failure

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 months

Awards & highlights

Study 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).Check my eligibility

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.See study design

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

Select...

I am currently taking tacrolimus or sirolimus.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pharmaceutical Preparations

Secondary outcome measures

Standard deviation of antirejection medication dose timing

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,447 Total Patients Enrolled

2 Trials studying Kidney Failure

795 Patients Enrolled for Kidney Failure

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,542 Total Patients Enrolled

10 Trials studying Kidney Failure

10,720 Patients Enrolled for Kidney Failure

Cyd Eaton, PhDPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

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

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"Per information available on clinicaltrials.gov, patient recruitment is ongoing for this trial. It was initially listed on 3/1/2024 and most recently revised on 2/28/2024."

Answered by AI

How large is the participant pool for this particular research endeavor?

"Yes, information from clinicaltrials.gov indicates that this investigation is actively seeking individuals. The study was initially listed on March 1, 2024, and last revised on February 28, 2024. Recruitment aims to enroll a total of 50 patients at one designated site."

Answered by AI

Is the research study open to participants aged 85 and older?

"To be eligible for this research project, individuals aged between 13 and 25 are sought. Notably, there are currently 31 investigations focused on participants under 18 years old and an additional 237 studies targeting those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant

2024. "Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05613010.

All > Liver Transplant > Kidney Transplant