Adherence Enhancement for Renal Transplant Patients

Not Applicable

Completed

• Conditions: Medication Adherence; Hypertension; Renal Failure
• Interventions: Behavioral: mHealth

• Registration Number: NCT01859273
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-21
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth	mHealth	subjects provided with electronic medication tray, electronic blood pressure cuff, and a smart phone.

Primary Outcome Measures

Name	Time	Method
medication adherence	5 months	adherence to immunosuppressive medications

Secondary Outcome Measures

Name	Time	Method
blood pressure	5 months	resting blood pressure

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States