Text Messaging for Adherence in Adolescent Liver Transpla... | NCT01696331

Studies
Text Messaging for Adherence in Adolescent Liver Transplant Recipients

NCT01696331

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 19, 2018Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Liver Transplant
Adherence

Interventions

Text Message Reminder

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Sep 27, 2012

First Submission Date that Met QC Criteria

Sep 28, 2012

First Posted Date

Oct 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2018

Last Update Posted Date

Apr 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rebecca Berquist McKenzie, Clinical Instructor, Department of Pediatric Gastroenterology, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Text message reminders will improve adherence to lab tests in adolescent liver transplant recipients.

Detailed Description

Adolescent patients who received a liver transplant will be recruited to participate in receiving text message reminders for lab tests. They will be send de-identified messages according to their required lab schedule. The investigators will monitor their adherence to lab tests as well as medication and clinic visits. They will also have a questionnaire about their medical regimen before and at the end of the study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Text Message Reminder	Experimental		Behavioral: Text Message Reminder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Text Message Reminder	Behavioral	Sent TM reminder at beginning and end of each month that corresponded to required lab frequency. Patients were able to send autoresponses.	Text Message Reminder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence to lab tests		One year

Secondary Outcomes

Measure	Description	Time Frame
Texting responses	Correspondence between actual completion of tests versus reported	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient >12 years
Received liver transplant
Followed by Stanford Liver Transplant Team

Exclusion Criteria:

No personal cell phone

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lucile Packard Children's Hospital		Palo Alto	California	94304	United States