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

Medication Adherence Clinical Trial

— mDOT  

Official title:

mDOT: A Pilot Study of Video Directly Observed Therapy for Immunosuppressant Adherence in Adult Kidney Transplant Recipients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03427008
• Other study ID #: IRB00164573
• Status: Withdrawn
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: November 12, 2020

Study information

• Verified date: March 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 immunosuppression medication adherence among adult kidney 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 kidney transplant recipients at the Johns Hopkins Hospital.

Description:

In adult kidney transplant recipients, the leading predictor of rejection, kidney loss, and death is immunosuppressive medication nonadherence. An estimated one-third of kidney transplant recipients reportedly experience medication nonadherence, and even minor deviations from the required protocol have been shown to have negative effects. However, due to the lack of systematic measurements of adherence, the direct relationship between the level of immunosuppressive medication adherence and poor outcomes is not well understood. Therefore, the investigators believe that mHealth technologies could be a feasible way to allow clinicians and researchers to better understand baseline adherence measurements, and increase immunosuppression adherence among kidney transplant recipients.

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, access educational content, and track appointments. 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 system 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:

• Adults (=22 years)

• Receive a kidney transplant at the Johns Hopkins Hospital

Exclusion Criteria:

• Non-English speaking participants

Related Conditions & MeSH terms

• Medication Adherence
• Transplant; Kidney

Intervention

Other:
• mHealth Intervention
The mHealth app will allow transplant recipients to see their medication regimen, record themselves taking every dose, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. 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 (13)

Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation. 2004 Mar 15;77(5):769-76. — 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

De Geest S, Abraham I, Moons P, Vandeputte M, Van Cleemput J, Evers G, Daenen W, Vanhaecke J. Late acute rejection and subclinical noncompliance with cyclosporine therapy in heart transplant recipients. J Heart Lung Transplant. 1998 Sep;17(9):854-63. — View Citation

De Geest S, Borgermans L, Gemoets H, Abraham I, Vlaminck H, Evers G, Vanrenterghem Y. Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients. Transplantation. 1995 Feb 15;59(3):340-7. — View Citation

De Geest S, Sabaté E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. — View Citation

Desmyttere A, Dobbels F, Cleemput I, De Geest S. Noncompliance with immunosuppressive regimen in organ transplantation: is it worth worrying about? Acta Gastroenterol Belg. 2005 Jul-Sep;68(3):347-52. Review. — View Citation

Dew MA, DiMartini AF, De Vito Dabbs A, Myaskovsky L, Steel J, Unruh M, Switzer GE, Zomak R, Kormos RL, Greenhouse JB. Rates and risk factors for nonadherence to the medical regimen after adult solid organ transplantation. Transplantation. 2007 Apr 15;83(7):858-73. — View Citation

Douglas S, Blixen C, Bartucci MR. Relationship between pretransplant noncompliance and posttransplant outcomes in renal transplant recipients. J Transpl Coord. 1996 Jun;6(2):53-8. Review. — View Citation

Gordon EJ, Gallant M, Sehgal AR, Conti D, Siminoff LA. Medication-taking among adult renal transplant recipients: barriers and strategies. Transpl Int. 2009 May;22(5):534-45. doi: 10.1111/j.1432-2277.2008.00827.x. Epub 2009 Jan 16. — View Citation

Hong JH, Sumrani N, Delaney V, Davis R, Dibenedetto A, Butt KM. Causes of late renal allograft failure in the ciclosporin era. Nephron. 1992;62(3):272-9. — View Citation

Nevins TE, Kruse L, Skeans MA, Thomas W. The natural history of azathioprine compliance after renal transplantation. Kidney Int. 2001 Oct;60(4):1565-70. — View Citation

Shoskes DA, Avelino L, Barba L, Sender M. Patient death or renal graft loss within 3 yr of transplantation in a county hospital: importance of poor initial graft function. Clin Transplant. 1997 Dec;11(6):618-22. — View Citation

Takemoto SK, Pinsky BW, Schnitzler MA, Lentine KL, Willoughby LM, Burroughs TE, Bunnapradist S. A retrospective analysis of immunosuppression compliance, dose reduction and discontinuation in kidney transplant recipients. Am J Transplant. 2007 Dec;7(12):2704-11. Epub 2007 Sep 14. — View Citation

* Note: There are 13 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, the range being Strongly Agree, Agree, Slightly Agree, Neither Agree nor Disagree, Slightly Disagree, Disagree, and Strongly Disagree.	12 weeks