Automated text messages for Kidney Transplantation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Kidney Transplantation
Automated text messages - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Home-based Therapeutic Drug Monitoring in Kidney Transplantation

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Automated text messages will improve 1 primary outcome and 2 secondary outcomes in patients with Kidney Transplantation. Measurement will happen over the course of 2 days.

2 days
Bioanalytical assay agreement for mycophenolic acid
Bioanalytical assay agreement for tacrolimus
3 months
Successful home-based therapeutic drug monitoring

Trial Safety

Trial Design

2 Treatment Groups

Unidirectional Text Reminders
1 of 2
Bidirectional Text Communication
1 of 2
Active Control
Experimental Treatment

This trial requires 45 total participants across 2 different treatment groups

This trial involves 2 different treatments. Automated Text Messages is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Bidirectional Text Communication
Behavioral
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
Unidirectional Text Reminders
Behavioral
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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months for reporting.

Who is running the study

Principal Investigator
M. P. P.
Prof. Manjunath Prakash Pai, Professor of Clinical Pharmacy
University of Michigan

Closest Location

University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Willing to received text messages with a mobile device capable of receiving messages
Ability to understand, read, and speak English
Ability to understand and willingness to sign written informed consent
Recipient of a kidney or kidney/pancreas transplant
Receiving immediate-release tacrolimus and mycophenolate mofetil
Willing to receive standard labs at a Michigan Medicine lab draw site on 2 occasions

Patient Q&A Section

What causes kidney transplantation?

"The main cause of a [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant) is lack of dialysis. Other causes include blood diseases (including diabetes, glomerulonephritis and immune-mediated disorders), infections, cancer and congenital malformations. The graft is normally discarded (for example, a living donor transplant) if its long-term function can be reasonably predicted to be poorer than dialysis alone." - Anonymous Online Contributor

Unverified Answer

How many people get kidney transplantation a year in the United States?

"There were more than 700,000 new [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant) recipients in the United States in 2002. The overwhelming majority of the recipients (97% in 2003) received their graft from an unrelated (vs. 93% from related) blood donor. The 5-year graft success rate from the first kidney transplant in the United States was 63.5% (from 1997 to 2002)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for kidney transplantation?

"Renal function is mainly preserved in the first year of transplantation. After transplantation, however, immunosuppressant medication must be carefully controlled or not taken at all. Other drugs used in transplant waiting list are metformin and statins, and also ACE inhibitors (ACE=angiotensin converting enzyme)." - Anonymous Online Contributor

Unverified Answer

Can kidney transplantation be cured?

"Kidney transplantation is a curative treatment in most cases. However, some cases may still evolve to renal insufficiency, requiring dialysis, or rejection of the graft." - Anonymous Online Contributor

Unverified Answer

What are the signs of kidney transplantation?

"Symptoms are common in the first 2 months following [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation. The most frequently reported symptoms were feeling tired, abdominal or back pain, weight changing, dry mouth, or urinary or febrile urinary tract infections or fever. There were few other symptoms that contributed significantly to a negative change in the patient's quality of life. Patients were also less satisfied with their transplantation, possibly due to dissatisfaction with their posttransplant education. Further research into ways to improve patient education about transplantation as well as posttransplant outcomes is required." - Anonymous Online Contributor

Unverified Answer

What is kidney transplantation?

"Transplant recipients who remain free from high-risk infections while using antiviral agents for 7 days prior to transplantation can have lower incidences of BK viremia and rejection. The use of pre-transplant antimicrobial prophylaxis prior to transplantation does not appear to be associated with the incidence of infection or rejection." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating kidney transplantation?

"In many cases, advances in understanding the mechanisms of the transplanted vasculature after transplantation provide the basis for new pharmacological therapies. In kidney transplantation, the emerging therapeutic strategy for prevention of acute rejection involves the blockade of endothelial cell activation, cytokine release and monocyte recruitment to the transplant site. Such therapies are undergoing investigation as is the ongoing development of new immunosuppressive regimens to prevent graft rejection and prolong the organ's functional life. In many instances, these therapies are based on the use or development of a new family of anti-angiogenesis agents." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of kidney transplantation?

"The leading risk factor for [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation is ESRD, followed by diabetes or hypertension. Therefore, it is helpful to evaluate the status of the transplant candidates before making a decision." - Anonymous Online Contributor

Unverified Answer

What is automated text messages?

"This was a small, single-site study using only two automated message recipients for a 12-month follow-up period, which was of short duration and not randomized." - Anonymous Online Contributor

Unverified Answer

How does automated text messages work?

"This technology improves physician communication and communication between patients and families, improves the quality of medical care, reduces health care costs, and increases overall patient satisfaction. While text messaging may have advantages over face-to-face communication, it has the disadvantage that it may become costly." - Anonymous Online Contributor

Unverified Answer

Does automated text messages improve quality of life for those with kidney transplantation?

"Automated text messaging provides a cost-effective means of communication and is superior to verbal communication in improving the quality of life in persons awaiting kidney transplantation." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for kidney transplantation?

"Patient knowledge about clinical trials, attitudes toward participation in clinical trials, and personal and racial preferences had no predictive value in identifying candidates to participate in kidney transplantation clinical trials. Patient knowledge and attitudes toward clinical trials are important to all patients prior to clinical trial engagement." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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