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OpenTrials
Completed

NCT Number: NCT01859273

Adherence Enhancement for Renal Transplant Patients

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.

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Key information

Conditions

Renal Failure Behavior Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Hypertension Kidney Diseases Male Urogenital Diseases Medication Adherence Patient Acceptance of Health Care Patient Compliance Renal Insufficiency Treatment Adherence and Compliance Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mHealth

Behavioral

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

Primary outcomes

  1. medication adherence

    Time frame: 5 months

    adherence to immunosuppressive medications

Secondary outcomes

  1. blood pressure

    Time frame: 5 months

    resting blood pressure

Other outcomes

  1. acceptability

    Time frame: 5 months

    patients' willingness to utilize the protocol mHealth system

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 21, 2013
Registry last updated
Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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