CClinicalTrials.gg
CompletedNCT01826721Updated Apr 8, 2013

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

An interventional study of Transplant Medication Information Teaching Tool in Solid Organ Transplantation, sponsored by Jennifer Harrison. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2013-04-08.

Sponsored by Jennifer Harrison · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
246
Allocation
Randomized
Sex
All
01

Study summary

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.

02

Conditions studied

  • Solid Organ Transplantation

Keywords

  • Solid organ transplantation
  • Immunosuppression
  • Education
  • E-learning
  • Medication knowledge
  • Patient satisfaction
  • Medication adherence
03

In context

Lead sponsor

This is the only study on the registry with Jennifer Harrison as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
246 participants (actual)

Study arms

  • No intervention
    Standard of Care

    Patients in the Standard of Care arm receive the usual in-hospital post-transplant medication teaching class led by a transplant pharmacist.

  • Active comparator
    TMITT

    Patients in this arm receive the standard of care plus the TMITT educational intervention.

    Other: Transplant Medication Information Teaching Tool

Interventions

  • OtherTransplant Medication Information Teaching Tool

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Patient Satisfaction

    Patient satisfaction with medication information received.

    Time frame: Baseline and 3 months

  2. Medication Adherence

    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.

    Time frame: 3 months

07

Study locations

1 site
  • Toronto General Hospital
    Toronto, Ontario M5G 2N2, Canada
08

References and documents

Publications

  • Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2. PubMed 36094829 ↗
  • Harrison JJ, Badr S, Hamandi B, Kim SJ. Randomized Controlled Trial of a Computer-Based Education Program in the Home for Solid Organ Transplant Recipients: Impact on Medication Knowledge, Satisfaction, and Adherence. Transplantation. 2017 Jun;101(6):1336-1343. doi: 10.1097/TP.0000000000001279. PubMed 27367473 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01826721
Lead sponsor
Jennifer Harrison
Responsible party
Jennifer Harrison (Pharmacy Clinical Site Leader, University Health Network, Toronto) — Sponsor-investigator
First posted
Apr 8, 2013
Start date
May 2011
Primary completion
Oct 2012
Completion
Mar 2013
Last update
Apr 8, 2013

Study contacts

Jennifer Harrison, BScPhm, MSc
principal investigator · University Health Network, Toronto General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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