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Adherence Enhancement for Renal Transplant Patients

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Hypertension
Medication Adherence
Renal Failure

Treatments

Behavioral: mHealth

Study type

Interventional

Funder types

Other

Identifiers

NCT01859273
Pro00011702

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Standard Care
No Intervention group
Description:
Standard Care after kidney transplantation
mHealth
Experimental group
Description:
subjects provided with electronic medication tray, electronic blood pressure cuff, and a smart phone.
Treatment:
Behavioral: mHealth

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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