Adherence Enhancement for Renal Transplant Patients

Hypertension Clinical Trial

Official title:

Adherence Enhancement for Renal Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859273
• Other study ID #: Pro00011702
• Status: Completed
• Phase: N/A
• First received: May 17, 2013
• Last updated: June 8, 2016
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: June 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Exclusion Criteria:

• failure to meet all inclusion criteria

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Medication Adherence
• Renal Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Review. — 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

Denhaerynck K, Dobbels F, Cleemput I, Desmyttere A, Schäfer-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. Review. — View Citation

Mange KC, Cizman B, Joffe M, Feldman HI. Arterial hypertension and renal allograft survival. JAMA. 2000 Feb 2;283(5):633-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	acceptability	patients' willingness to utilize the protocol mHealth system	5 months	No
Primary	medication adherence	adherence to immunosuppressive medications	5 months	No
Secondary	blood pressure	resting blood pressure	5 months	No