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mHealth Application for Living Donor Follow-Up (mHealth Trial)

N/A

Waitlist Available

Led By Macey Henderson, JD, 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

Adults (≥18 years)

Have undergone live donor nephrectomy at Methodist Specialty and Transplant Hospital in San Antonio, Texas

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether or not using a mobile health application increases the rate of follow-up compliance among living kidney donors.

Who is the study for?

This trial is for adults who have donated a kidney and undergone nephrectomy at Methodist Specialty and Transplant Hospital in San Antonio, Texas or Vanderbilt University Medical Center in Nashville, Tennessee. Participants must consent to the study.

What is being tested?

The study tests if a mobile health (mHealth) application can improve follow-up compliance among living kidney donors post-donation. Donors are randomly placed into two groups: one uses the mHealth app for follow-ups; the other follows standard care.

What are the potential side effects?

Since this trial involves an mHealth application rather than medication, traditional side effects are not applicable. However, participants may experience issues related to app usability or technical difficulties.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I had a kidney removal surgery from a living donor at Methodist Specialty and Transplant Hospital in San Antonio, Texas.

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I had a kidney removal surgery from a living donor at Vanderbilt University Medical Center.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

1-year compliance to follow-up

2-year compliance to follow-up

6-month compliance to follow-up

Secondary study objectives

1-year center follow-up compliance

2-year center follow-up compliance

6-month center follow-up compliance

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: mHealth applicationExperimental Treatment1 Intervention

Participants in the intervention arm will receive the mHealth application at their first post-donation clinic visit. Study personnel will assist participants assigned to the mHealth intervention arm with downloading the application and explain its functioning. Participants will then use the application to complete their required 6-month, 1-year, and 2-year follow-up.

Group II: Standard of CareActive Control1 Intervention

The control participants will be instructed to attend required follow-up as is standard of care, and will not receive the mHealth application.

0 / 3Eligibility criteria met