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OpenTrials
Completed

NCT Number: NCT01826721

Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial

Solid organ transplant recipients (SOTR) must follow complex medication regimens and require a substantial amount of education for effective self-management. The current standard of care for post-transplant medication teaching is a Self Medication education program conducted in hospital by the pharmacist. The Transplant Medication Information Teaching Tool (TMITT) is a web-based e-learning tool for SOTR developed at the Toronto General Hospital. The ability to control the content, sequence, pace and timing of education in order to achieve personal learning objectives, as well as the opportunity for ongoing review and reinforcement of information, may be an attractive, convenient and effective teaching modality.

SOTR will be randomly assigned to receive the standard of care or the standard of care plus the TMITT intervention. Primary objectives are to compare patient satisfaction and medication knowledge between the two groups at baseline and 3 months using modified versions of previously published questionnaires. Medication adherence as measured by a multidimensional approach including both subjective and objective components, will also be compared at 3 months. Our hypothesis is that an education strategy that includes both the standard pharmacist teaching followed by a tailored online e-learning intervention post-discharge will lead to improved patient satisfaction, knowledge and medication adherence.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all patients undergoing solid organ transplantation at Toronto General Hospital during the study period

Exclusion criteria

  • non-English speaking/reading
  • no internet access at home
  • planned discharge to a rehab facility without internet access
  • not on a calcineurin inhibitor (CNI) or sirolimus
  • attending the Self Medication class on the same day as hospital discharge
  • cognitive impairment that precludes participation in Self Medication program (as per the assessment of the transplant pharmacist)
  • incapable of providing informed consent

Treatment and study plan

Transplant Medication Information Teaching Tool

Other

Online e-learning tool for post-transplant medication education.

Primary outcomes

  1. Change in Medication Knowledge Score from baseline to 3 months

    Time frame: Baseline and 3 months

    Medication Knowledge Score consists of 2 parts - recall of medication regimen and multiple choice knowledge questionnaire.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: Baseline and 3 months

    Patient satisfaction with medication information received.

  2. Medication Adherence

    Time frame: 3 months

    Adherence to the immunosuppressant medication regimen is evaluated using the Multidimensional Adherence Classification System. This consists of patient self-report and measurement of standard deviation of immunosuppressant blood levels.

Sponsors and collaborators

Lead sponsor

Jennifer Harrison

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 8, 2013
Registry last updated
Apr 8, 2013

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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