Do Technology Apps Improve Compliance in Adolescent Renal Transplant Recipients?

NCT02610946 | Unknown DMC

• 1 other identifier: StanfordU TeenTransplant
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to empower adolescent renal transplant recipients to fully understand their medical condition as well as to help them acquire the skills to maintain a healthy allograft well into adulthood. It is hoped that introducing technological applications (apps) will assist adolescents in managing medications, clinic appointments, lab appointments, and in tracking fluid intake, blood pressure, caloric intake, and exercise frequency. The investigators aim to improve adolescent post-renal transplant outcomes (increase medication adherence, lower clinic and laboratory no-show rate, lower blood pressure and BMI, maintain creatinine clearance, decrease proteinuria, decrease incidence of allograft rejection, decrease hospitalizations) as well as reduce cost.

Conditions

Kidney Transplantation

Keywords

pediatric; adolescent; compliance

Outcome Measures

Primary Outcomes (1)

• Compliance

  Ability to adhere to medical recommendations of transplant care assessed by presence or absence of antibody-mediated rejection based on donor-specific antibody levels.

  1 year

Secondary Outcomes (1)

• Readiness to transition

  1 year

Study Arms (2)

Paper-based

PLACEBO COMPARATOR

Use of paper-based calenders, reminders, medication list, and blood pressure, fluid intake tracking methods in adolescent renal transplant care

Behavioral: Paper-based

Electronic application

EXPERIMENTAL

Use of electronic apps (iphone or i-Pad mini) to determine whether it can improve compliance with transplant care and readiness to transition to adult care.

Behavioral: Electronic application

Interventions

Electronic application BEHAVIORAL

Electronic application (app) based intervention to improve adolescent compliance with transplant care and readiness to transition to adult care.

Electronic application

Paper-based BEHAVIORAL

Paper-based intervention to improve adolescent compliance with transplant care and readiness to transition to adult care.

Paper-based

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent patients between 12 and 18 years of age with kidney transplants seen at Lucile Packard Children's Hospital for their transplant care at least every 3 months.

You may not qualify if:

• Non-English speaking,
• significant cognitive delays,
• seen in clinic less often than every 3 months.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospital and Clinics

Palo Alto, California, 94305, United States

RECRUITING

Related Publications (1)

• Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

  PMID: 36094829 DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ha Tran, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ha Tran, MD

CONTACT

650-723-7903; hatran@stanford.edu

Priya Chandra, MD

CONTACT

650-723-7903; priyac1@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 20, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

US (1)