- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995770
Text Messages for Liver Transplant Recipients
Text Messages for Adolescent and Young Adult Liver Transplant Recipients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed randomized control pilot study will be based at the Liver Transplant Clinic at CHLA. Approximately 25 participants will be randomly assigned to the intervention arm, whereas 25 participants will be assigned to treatment as usual (TAU), for a total sample size of N = 50. As there are approximately 90 patients who meet inclusion criteria currently in care, recruiting 50 for this study is feasible. The intervention will last for six months. During this time, participants in the intervention arm will receive a brief text-message on their cell-phones whenever laboratory blood tests indicate that immunosuppressant medications are within the expected range. This will primarily be measured via trough levels of calcineurin inhibitors, but will also take into account complete blood count, comprehensive metabolic panel, and magnesium level results, as reviewed by the transplant physician. The purpose of these text messages is to alert participants that physicians are indeed checking participant liver levels and recognizing when participants are putting in the work to keep themselves healthy. Multiple standardized text messages will be created so that participants do not receive identical ones each time. An example text message may include "Your liver levels have been checked and look good. The effort you are putting into taking your meds shows!" Participants in the TAU arm will not receive any text messages.If trough levels or any other study measure indicates possible nonadherence, nonadherence will still be addressed by their physicians, social work, or whatever is indicated per clinic standard of care. Furthermore, additional psychosocial or medical support will not be withheld from patients whose labs indicate nonadherence for either the intervention or TAU arms.
All participants will complete questionnaires at four points: Baseline, mid-way through the intervention period (three-months), immediately after the conclusion of the intervention (six-months), and three months post-intervention. Participants will complete self-report measures assessing medication adherence (Visual Analogue Scale), participants' sense of trust in their medical providers (Trust in Physician Scale) and motivation for medication adherence (Rollnick's Readiness Ruler). In addition, participants will complete self-reported measures of anxiety (General Anxiety Disorder-7), depression (Patient Health Questionnaire-9), and socioeconomic status (Family Affluence Scale II). Several variables will also be abstracted from the electronic medical record, from one year prior to study enrollment to one year post study enrollment. At the end of the intervention, participants will complete an exit survey assessing its feasibility and acceptability. They will be asked to discuss which components of the intervention were most helpful, so this information can be used for possible dismantling study approaches in the future. Twenty-five participants will also be randomly selected and asked to participate in a 30-60 minute telephone interview in order to assess feasibility and acceptability of the study, as well as gain their insight regarding potentially helpful future interventions. Medical or psychosocial support will not be withheld from patients who drop out of the study or do not complete study measures. All data will be collected via Redcap, a HIPAA-compliant on-line platform that will allow participants to complete measures securely on-line at home.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- having a liver transplant
- receiving care at Children's Hospital Los Angeles
- having access to a working cellphone
- speaking English.
Exclusion Criteria:
- insufficient cognitive capacity to understand or engage in the procedures of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Praise Text Messages
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!."
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Texting messages with praise content, to positive reinforce medication adherence
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No Intervention: Usual Care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Reported Medication Adherence
Time Frame: 9 months
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Visual Analogue Scale (0-100% range, with higher scores indicating better values)
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9 months
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Medication Variability Observed in Immunosuppressant Labs
Time Frame: 12 months
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medication level variability index (calculated as standard deviation of at least 3 lab values, with lower scores indicating better values)
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation for Adherence
Time Frame: 9 months
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Rollnick's Readiness Ruler (0-10 range, with higher scores indicating better values)
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9 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Rollnick S, Miller WR, Butler C. Motivational interviewing in health care: helping patients change behavior. Guilford Press; 2008.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHLA-19-00189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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