NCT03427008

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
Last Updated

September 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

February 2, 2018

Last Update Submit

September 17, 2021

Conditions

Medication AdherenceTransplant; Kidney

Keywords

mHealthkidney transplantationmedication adherencevideo directly observed therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey

    12 weeks

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants in the control arm will be instructed to take their immunosuppressive medications as prescribed and attend required follow-up as is standard of care, and will not receive the mHealth app.

mHealth Intervention

EXPERIMENTAL

Participants in the intervention arm will receive the mHealth app either while they are an inpatient post-transplant, or at their first post-transplant clinic visit. Study personnel will assist participants assigned to the mHealth intervention arm with downloading the mHealth app and explain its functioning. Participants will then use the application to aid in immunosuppressive medication adherence post-transplant.

Other: mHealth Intervention

Interventions

mHealth InterventionOTHER

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.

mHealth Intervention

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥22 years)
  • Receive a kidney transplant at the Johns Hopkins Hospital

You may not qualify if:

  • Non-English speaking participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (14)

  • 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.

    PMID: 7871562BACKGROUND

  • 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. doi: 10.1159/000187058.

    PMID: 1436337BACKGROUND

  • 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. doi: 10.1046/j.1523-1755.2001.00961.x.

    PMID: 11576374BACKGROUND

  • 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.

    PMID: 9408696BACKGROUND

  • 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. doi: 10.7182/prtr.1.6.2.x11r325882657x21.

    PMID: 9188358BACKGROUND

  • 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. No abstract available.

    PMID: 16268422BACKGROUND

  • 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. doi: 10.1097/01.tp.0000258599.65257.a6.

    PMID: 17460556BACKGROUND

  • De Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available.

    PMID: 14667488BACKGROUND

  • 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.

    PMID: 19175560BACKGROUND

  • 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.

    PMID: 9773856BACKGROUND

  • 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. doi: 10.1097/01.tp.0000110408.83054.88.

    PMID: 15021846BACKGROUND

  • 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. doi: 10.1111/j.1600-6143.2007.01966.x. Epub 2007 Sep 14.

    PMID: 17868065BACKGROUND

  • 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. doi: 10.1016/j.pec.2004.09.003.

    PMID: 16198214BACKGROUND

  • Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

    PMID: 36094829DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Macey Henderson, JD,PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Daniel Brennan, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a single center, prospective, randomized control trial with two arms. Participants in the intervention arm will use the mHealth app to manage and track their immunosuppression medical regimen post-transplant, and participants in the control arm will receive the current standard of follow-up care post-transplant.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 9, 2018

Study Start

September 30, 2018

Primary Completion

November 12, 2020

Study Completion

November 12, 2020

Last Updated

September 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)