Adherence Enhancement for Renal Transplant Patients

NCT ID: NCT01859273

Last Updated: 2016-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-08-31

Brief Summary

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Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a "bundled" wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.

Detailed Description

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Conditions

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Renal Failure Medication Adherence Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Care

Standard Care after kidney transplantation

Group Type NO_INTERVENTION

No interventions assigned to this group

mHealth

subjects provided with electronic medication tray, electronic blood pressure cuff, and a smart phone.

Group Type EXPERIMENTAL

mHealth

Intervention Type BEHAVIORAL

mHealth prototype system consisting of electronic medication tray, blood pressure cuff and smart phone

Interventions

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mHealth

mHealth prototype system consisting of electronic medication tray, blood pressure cuff and smart phone

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Persons \> 21 years of age
* first time recipient of a solitary kidney transplant
* prescribed at least 3 medications for immunosuppression and hypertension
* previous history of non-adherence
* functioning kidney transplant
* ability to speak, hear and understand English
* able to use medication delivery device and self administer medications
* able to operate blood pressure monitor
* comfortable using cell phone
* no other diagnosis that might shorten lifespan
* transplant physician's assent that the patient can participate
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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John W. McGillicuddy

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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john w mcgillicuddy, md

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 7871562 (View on PubMed)

Vlaminck H, Maes B, Evers G, Verbeke G, Lerut E, Van Damme B, Vanrenterghem Y. Prospective study on late consequences of subclinical non-compliance with immunosuppressive therapy in renal transplant patients. Am J Transplant. 2004 Sep;4(9):1509-13. doi: 10.1111/j.1600-6143.2004.00537.x.

Reference Type BACKGROUND
PMID: 15307839 (View on PubMed)

Russell CL, Conn VS, Ashbaugh C, Madsen R, Hayes K, Ross G. Medication adherence patterns in adult renal transplant recipients. Res Nurs Health. 2006 Dec;29(6):521-32. doi: 10.1002/nur.20149.

Reference Type BACKGROUND
PMID: 17131276 (View on PubMed)

De Bleser L, Matteson M, Dobbels F, Russell C, De Geest S. Interventions to improve medication-adherence after transplantation: a systematic review. Transpl Int. 2009 Aug;22(8):780-97. doi: 10.1111/j.1432-2277.2009.00881.x. Epub 2009 Apr 6.

Reference Type BACKGROUND
PMID: 19386076 (View on PubMed)

Russell C, Conn V, Ashbaugh C, Madsen R, Wakefield M, Webb A, Coffey D, Peace L. Taking immunosuppressive medications effectively (TIMELink): a pilot randomized controlled trial in adult kidney transplant recipients. Clin Transplant. 2011 Nov-Dec;25(6):864-70. doi: 10.1111/j.1399-0012.2010.01358.x. Epub 2010 Nov 16.

Reference Type BACKGROUND
PMID: 21077956 (View on PubMed)

Denhaerynck K, Dobbels F, Cleemput I, Desmyttere A, Schafer-Keller P, Schaub S, De Geest S. Prevalence, consequences, and determinants of nonadherence in adult renal transplant patients: a literature review. Transpl Int. 2005 Oct;18(10):1121-33. doi: 10.1111/j.1432-2277.2005.00176.x.

Reference Type BACKGROUND
PMID: 16162098 (View on PubMed)

Mange KC, Cizman B, Joffe M, Feldman HI. Arterial hypertension and renal allograft survival. JAMA. 2000 Feb 2;283(5):633-8. doi: 10.1001/jama.283.5.633.

Reference Type BACKGROUND
PMID: 10665703 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36094829 (View on PubMed)

McGillicuddy JW, Gregoski MJ, Weiland AK, Rock RA, Brunner-Jackson BM, Patel SK, Thomas BS, Taber DJ, Chavin KD, Baliga PK, Treiber FA. Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial. JMIR Res Protoc. 2013 Sep 4;2(2):e32. doi: 10.2196/resprot.2633.

Reference Type DERIVED
PMID: 24004517 (View on PubMed)

Other Identifiers

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Pro00011702

Identifier Type: -

Identifier Source: org_study_id

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