NCT01826721

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

1.4 years

First QC Date

April 1, 2013

Last Update Submit

April 3, 2013

Conditions

Keywords

Solid organ transplantationImmunosuppressionEducationE-learningMedication knowledgePatient satisfactionMedication adherence

Outcome Measures

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.

    Baseline and 3 months

Secondary Outcomes (2)

  • Patient Satisfaction

    Baseline and 3 months

  • Medication Adherence

    3 months

Study Arms (2)

Standard of Care

NO INTERVENTION

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

TMITT

ACTIVE COMPARATOR

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

Other: Transplant Medication Information Teaching Tool

Interventions

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

TMITT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Patient SatisfactionMedication Adherence

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorPatient CompliancePatient Acceptance of Health Care

Study Officials

  • Jennifer Harrison, BScPhm, MSc

    University Health Network, Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pharmacy Clinical Site Leader

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 8, 2013

Study Start

May 1, 2011

Primary Completion

October 1, 2012

Study Completion

March 1, 2013

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations