Solid Organ TransplantationNCT01826721
Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial
A study testing Transplant Medication Information Teaching Tool in people with Solid Organ Transplantation, run by Jennifer Harrison at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Organ Transplantation
- What is being tested?
- Transplant Medication Information Teaching Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients undergoing solid organ transplantation at Toronto General Hospital during the study period
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Solid Organ Transplantation
- Being tested
- Transplant Medication Information Teaching Tool
- Keywords
- Solid organ transplantation, Immunosuppression, Education, E-learning, Medication knowledge, Patient satisfaction, Medication adherence
- Medical subject headings
- Patient Satisfaction, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplant Medication Information Teaching ToolOther
Online e-learning tool for post-transplant medication education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transplant Medication Information Teaching Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (2)
Patient Satisfaction
Patient satisfaction with medication information received.
Measured: Baseline and 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMay 2011
- Primary completionOct 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid Organ TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Harrison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Harrison, University Health Network, Toronto
- Investigators
- Jennifer Harrison, BScPhm, MSc, Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826721
- Sponsor's protocol ID
- REB10-0987-AE
- Status last verified
- Apr 2013
- First submitted
- 1 Apr 2013
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
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 36094829Harrison 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01826721
- Acronym / sponsor ID
- REB10-0987-AE
- Conditions
- Solid Organ Transplantation
- Keywords
- Solid organ transplantation, Immunosuppression, Education, E-learning, Medication knowledge, Patient satisfaction, Medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Jennifer HarrisonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Transplant Medication Information Teaching ToolPatients in this arm receive the standard of care plus the TMITT educational intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing solid organ transplantation at Toronto General Hospital during the study period
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplant Medication Information Teaching ToolOnline e-learning tool for post-transplant medication education. | Other | TMITT |
Primary outcome
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.
2 secondary outcomes
Patient Satisfaction
Time frame: Baseline and 3 months
Medication Adherence
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
- Derived from this study: PubMed 36094829Mellon 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.
- Derived from this study: PubMed 27367473Harrison 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 InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Harrison, BScPhm, MSc principal investigator
University Health Network, Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transplant Medication Information Teaching Tool in people with Solid Organ Transplantation, run by Jennifer Harrison at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Medication Knowledge Score from baseline to 3 months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01826721, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2013.