Text Messages for Liver Transplant Recipients

NCT04995770 | Completed

• 1 other identifier: CHLA-19-00189
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Although medical advancements have enabled children experiencing liver transplants to live longer, medical management post-transplant is ongoing and complex. Many findings underscore adolescents as being a particularly vulnerable population, with rates of nonadherence being four times higher than in adults. This pilot study aims to explore the feasibility and impact of a brief text-messaging intervention in a randomized controlled trials (N = 50). We have three primary aims: 1) Study patient satisfaction with and utilization of this intervention in order to better understand feasibility and acceptability; 2) Investigate the effects of this intervention on medication adherence, healthcare utilization, and health status; and 3) Examine potential effects of the intervention on the physician-patient relationship, motivation for adherence, and other variables.

Conditions

Medication Adherence; Liver Transplant Disorder

Outcome Measures

Primary Outcomes (2)

• Self-Reported Medication Adherence

  Visual Analogue Scale (0-100% range, with higher scores indicating better values)

  9 months

• Medication Variability Observed in Immunosuppressant Labs

  medication level variability index (calculated as standard deviation of at least 3 lab values, with lower scores indicating better values)

  12 months

Secondary Outcomes (1)

• Motivation for Adherence

  9 months

Study Arms (2)

Praise Text Messages

EXPERIMENTAL

The text message praise intervention lasted for 6 months. Each week, transplant coordinators, masked from who enrolled in the study or to which condition participants were randomized, prepared a list of all patients in the study age group whose laboratory blood tests indicated that immunosuppressant medications were within the expected range. A researcher reviewed the list to identify whether any of patients were currently assigned to the intervention, and if so, sent text message praise via REDCap's text message function. We rotated through 14 standardized text messages each week. Examples of messages included: "Your labs look very good. Super job taking your meds!" and "Your labs look great! Thanks for putting in the effort to take care of your health!."

Behavioral: Praise Text Messages

Usual Care

NO INTERVENTION

Participants in the usual care arm did not receive any praise text messages. All participants continued to receive usual care from the multidisciplinary liver transplant team, including phone calls and follow-up care when laboratory blood tests indicated that immunosuppressant medications were outside of the expected range.

Interventions

Praise Text Messages BEHAVIORAL

Texting messages with praise content, to positive reinforce medication adherence

Praise Text Messages

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• having a liver transplant
• receiving care at Children's Hospital Los Angeles
• having access to a working cellphone
• speaking English.

You may not qualify if:

• insufficient cognitive capacity to understand or engage in the procedures of the study

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (3)

• Walsh JC, Dalton M, Gazzard BG. Adherence to combination antiretroviral therapy assessed by anonymous patient self-report. AIDS. 1998 Dec 3;12(17):2361-3. No abstract available.

  PMID: 9863888 BACKGROUND

• Rollnick S, Miller WR, Butler C. Motivational interviewing in health care: helping patients change behavior. Guilford Press; 2008.

  BACKGROUND

• Shemesh E, Fine RN. Is calculating the standard deviation of tacrolimus blood levels the new gold standard for evaluating non-adherence to medications in transplant recipients? Pediatr Transplant. 2010 Dec;14(8):940-3. doi: 10.1111/j.1399-3046.2010.01396.x. Epub 2010 Oct 1.

  PMID: 20887400 BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Transplant coordinators were masked from intervention assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: August 1, 2019
• Primary Completion: December 26, 2020
• Study Completion: December 26, 2020
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)