Medication Adherence Clinical Trial
— mDOTOfficial title:
mDOT: A Pilot Study of Video Directly Observed Therapy for Immunosuppressant Adherence in Adult Kidney Transplant Recipients
Verified date | March 2021 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04709640 -
Pilot Study to Improve Medication Management in Older Adults
|
N/A | |
Completed |
NCT03257579 -
Myocardial Infarction Prescription Duration Adherence Study
|
N/A | |
Completed |
NCT05376397 -
Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
|
N/A | |
Completed |
NCT03805451 -
Life Steps for PrEP for Youth
|
N/A | |
Withdrawn |
NCT03292393 -
Social Norms and Antihypertensive Medication Adherence
|
N/A | |
Completed |
NCT02823795 -
The Supporting Patient Activation in Transition to Home Intervention
|
N/A | |
Completed |
NCT02914730 -
Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections
|
||
Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
Completed |
NCT02797262 -
Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
|
N/A | |
Completed |
NCT02066935 -
Non-adherence to Immunosuppressives in Kidney Transplantation in Brazil Multicenter Study
|
||
Completed |
NCT01934608 -
The Effect of Synching Prescription Refills on Adherence
|
N/A | |
Completed |
NCT01741311 -
Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
|
N/A | |
Completed |
NCT01770314 -
Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication.
|
Phase 2 | |
Recruiting |
NCT01105104 -
An Enhanced Medication Monitoring Program
|
Phase 1 | |
Withdrawn |
NCT01430702 -
Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults
|
N/A | |
Completed |
NCT01859273 -
Adherence Enhancement for Renal Transplant Patients
|
N/A | |
Completed |
NCT01118208 -
Blister Packaging Medication to Increase Treatment Adherence and Clinical Response
|
N/A | |
Completed |
NCT00848224 -
Improving Adherence to Pharmacological Treatment
|
N/A | |
Completed |
NCT06034301 -
Pill Bottle vs Reminder App
|
N/A | |
Recruiting |
NCT04585594 -
Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence
|
N/A |