A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Liver Transplant Recipients

Medication Adherence Clinical Trial

Official title:

A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adult Liver Transplant Recipients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03515330
• Other study ID #: IRB00173000
• Status: Withdrawn
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: November 12, 2020

Study information

• Verified date: August 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppressant medication adherence among adult liver transplant recipients. The investigators aim to test this by randomly assigning transplant recipients to the intervention (use of an mHealth app to manage and track their immunosuppression regimen) or control arm (standard of care) upon discharge from their initial transplant hospitalization, and tracking medication adherence over time. The study population will be approximately 50 adult liver transplant recipients at the Johns Hopkins Hospital.

Description:

In adult transplant recipients, poor adherence to immunosuppressant medications carries the risk of graft rejection, post-transplant complications, and increased healthcare costs. In adult liver transplant recipients, adherence to immunosuppressant drugs, as well as to general medical indications (e.g. avoiding alcohol intake), is imperative to short- and long-term outcomes. The rate of non-adherence to immunosuppressant medications in this population varies vastly, with reports ranging from 15-40%. Because of lacking objective and accurate non-adherence measurements, the true implications and prevalence of non-adherence is not yet well understood. Therefore, the investigators believe that mobile health (mHealth) technology has the potential to allow clinicians and researchers to more comprehensively address and understand non-adherence in adult liver transplant recipients. Additionally, an mHealth application with the ability to track symptoms, side effects, and alcohol cravings could provide clinicians with valuable information on post-transplant care. We will use a mobile health platform that enables users to track dose-by-dose medication adherence through asynchronous, video directly observed therapy (DOT). This helps patients take their medication as prescribed and gives providers the assurance that their patients are supported and successful in treatment. DOT is the practice of watching a patient take every dose of medicine in-person, and has typically only been done in extreme cases because it can be both costly and burdensome: DOT is the standard of care for Tuberculosis treatment and has proven high-adherence rates. Through mHealth technology, DOT can be used more broadly and without added burden; emocha's technology allows this through enabling patients to use their mobile application to view their regimen, record themselves taking every dose of their medication, report side effects or symptoms, visualize their treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to conduct a randomized control trial to compare medication adherence between patients who use the mHealth application against controls who do not.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 12, 2020
• Est. primary completion date: November 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Greater than or equal to 22 years of age
• Receive a liver transplant at Johns Hopkins Hospital

Exclusion Criteria:

• Non-English speaking liver transplant recipients

Related Conditions & MeSH terms

• Liver Transplant
• Medication Adherence

Intervention

Other:
• mHealth Intervention
The mHealth application will allow liver transplant recipients to see their medication regimen, record a video of themselves taking every dose, report side effects or symptoms, visualize their treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Burra P, Germani G, Gnoato F, Lazzaro S, Russo FP, Cillo U, Senzolo M. Adherence in liver transplant recipients. Liver Transpl. 2011 Jul;17(7):760-70. doi: 10.1002/lt.22294. Review. — View Citation

Chisholm MA, Lance CE, Williamson GM, Mulloy LL. Development and validation of the immunosuppressant therapy adherence instrument (ITAS). Patient Educ Couns. 2005 Oct;59(1):13-20. — View Citation

Dobbels F, Vanhaecke J, Desmyttere A, Dupont L, Nevens F, De Geest S. Prevalence and correlates of self-reported pretransplant nonadherence with medication in heart, liver, and lung transplant candidates. Transplantation. 2005 Jun 15;79(11):1588-95. — View Citation

Hathaway DK, Combs C, De Geest S, Stergachis A, Moore LW. Patient compliance in transplantation: a report on the perceptions of transplant clinicians. Transplant Proc. 1999 Jun;31(4A):10S-13S. — View Citation

Laederach-Hofmann K, Bunzel B. Noncompliance in organ transplant recipients: a literature review. Gen Hosp Psychiatry. 2000 Nov-Dec;22(6):412-24. Review. — View Citation

Mor E, Gonwa TA, Husberg BS, Goldstein RM, Klintmalm GB. Late-onset acute rejection in orthotopic liver transplantation--associated risk factors and outcome. Transplantation. 1992 Nov;54(5):821-4. — View Citation

Nahid P, Dorman SE, Alipanah N, Barry PM, Brozek JL, Cattamanchi A, Chaisson LH, Chaisson RE, Daley CL, Grzemska M, Higashi JM, Ho CS, Hopewell PC, Keshavjee SA, Lienhardt C, Menzies R, Merrifield C, Narita M, O'Brien R, Peloquin CA, Raftery A, Saukkonen J, Schaaf HS, Sotgiu G, Starke JR, Migliori GB, Vernon A. Executive Summary: Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis. Clin Infect Dis. 2016 Oct 1;63(7):853-67. doi: 10.1093/cid/ciw566. — View Citation

O'Carroll RE, McGregor LM, Swanson V, Masterton G, Hayes PC. Adherence to medication after liver transplantation in Scotland: a pilot study. Liver Transpl. 2006 Dec;12(12):1862-8. — View Citation

Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009 Nov;9(11):2597-606. doi: 10.1111/j.1600-6143.2009.02798.x. — View Citation

Singleton, E.G., Tiffany, S.T. & Henningfield, J.E. (2000). Alcohol Craving Questionnaire (ACQ-NOW): Background, Scoring, and Administration (Manual). Baltimore, MD: Intramural Research Program, National Institute on Drug Abuse.

Stilley CS, DiMartini AF, de Vera ME, Flynn WB, King J, Sereika S, Tarter RE, Dew MA, Rathnamala G. Individual and environmental correlates and predictors of early adherence and outcomes after liver transplantation. Prog Transplant. 2010 Mar;20(1):58-66; quiz 67. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-week immunosuppression medication adherence	After 12 weeks in the study, patients will complete the 4-item immunosuppressant therapy adherence instrument (ITAS) to determine self-reported medication adherence (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence). Additionally, immunosuppression level trends will be tracked via electronic medical record review to determine medication adherence.	12 weeks
Secondary	Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey	After 12 weeks in the study, participants will be asked to participate in a semi-structured phone interview in which they will answer questions regarding their medication adherence habits and their thoughts on how our mHealth technology was or was not helpful. They will also complete a 17-question post-satisfaction survey assessing their satisfaction levels with the mhealth technology. Responses in the 17-item survey are on a 7-item Likert scale, ranging from Strongly Agree to Strongly Disagree.	12 weeks
Secondary	Alcohol Craving Assessment	As abstaining from alcohol is important following liver transplantation, we will administer a daily question through the mDOT app asking about alcohol craving and use. Patients who screen positive for alcohol craving and or use through the daily in-app question will be referred to a transplant social worker who will administer the Alcohol Craving Questionnaire Short Form.	12 weeks