Educational ActivitiesNCT05189340
Development of Discharge Education Video for Solid Organ Transplant Recipients
A study testing Educational Videos in people with Educational Activities and Organ Transplants, run by Johns Hopkins University at 1 site in United States.
Trial summary
Audiovisual teaching aids can play a significant role for the retention of new material and help overcome barriers such as the physical presence or time restrictions of an instructor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Educational Activities, Organ Transplants
- What is being tested?
- Educational Videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 3 Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are solid organ transplant recipients at Johns Hopkins Hospital
- Patients who are being managed by an adult solid-organ transplant surgical service
- Patients who can speak and read the English language
Who cannot join
- Patients with language access services needs will be excluded
- Patients who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Audiovisual teaching aids can play a significant role for the retention of new material and help overcome barriers such as the physical presence or time restrictions of an instructor. In a clinical setting, multimedia health education can offer an advantage over traditional didactic teaching by engaging patients through visual content and unlimited accessibility.
A critical factor to long-term survival of solid organ transplant recipients is compliance to post-transplantation medication and follow-up patient care. Transplant pharmacists serve on multidisciplinary care teams as the medication experts that provide discharge education to recipients and caregivers often at the bedside. The adoption of digital multimedia content for patient education can increase engagement of diverse learning styles while simultaneously reducing potential time conflicts in hospital practice. This study contributes to the literature by assessing the effectiveness of discharge education video(s) on patient satisfaction and knowledge levels which are currently limited.
- Conditions
- Educational Activities, Organ Transplants
- Being tested
- Educational Videos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational VideosOther
Series of six videos each covering a specific aspect of post-transplant care related to medication use or monitoring
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Patients in the Standard of Care arm will receive pharmacist discharge education via fully in-person education as is currently being done. |
| Intervention | Experimental | Patients in the Intervention arm will have access to pre-recorded educational videos covering key educational points. Patients will also have in-person interaction with pharmacists to address additional questions not covered in the videos. Receives: Other: Educational Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Transplant Medication and Care Knowledge
Change in performance pre and post-education based on responses to questionnaire
Measured: Pre- and post-education; pre-education assessment will be completed as soon as feasible after transplant (estimate 1-3 days) and consent; post-education assessment will be completed as soon as is feasible after initial education (estimate 0-2 days)
Patient Satisfaction with Educational Method
Difference in satisfaction as determined by response to questionnaire post education. A single question score from 1 to 10 will be used, with 10 being highest satisfaction and 1 being the lowest level of satisfaction
Measured: As soon as feasible post-education, in concert with post-education knowledge assessment (estimate 0-2 days)
Secondary outcomes (1)
Pharmacist Time Requirement
Time required by pharmacist for education
Measured: As soon as feasible post-education (estimate 0-2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start11 Apr 2022
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ActivitiesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the standard of care arm will be enrolled through a specified date (currently targeting late February 2022, at which time enrolled patients will be included in the intervention group until data collection ceases in late April
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Whisler, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189340
- Sponsor's protocol ID
- IRB00303596
- Status last verified
- May 2022
- First submitted
- 29 Dec 2021
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Discharge Education Video for Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT05189340
- Acronym / sponsor ID
- IRB00303596
- Conditions
- Educational Activities, Organ Transplants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 12 Jan 2022 (actual)
- 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.
Audiovisual teaching aids can play a significant role for the retention of new material and help overcome barriers such as the physical presence or time restrictions of an instructor. In a clinical setting, multimedia health education can offer an advantage over traditional didactic teaching by engaging patients through visual content and unlimited accessibility.
A critical factor to long-term survival of solid organ transplant recipients is compliance to post-transplantation medication and follow-up patient care. Transplant pharmacists serve on multidisciplinary care teams as the medication experts that provide discharge education to recipients and caregivers often at the bedside. The adoption of digital multimedia content for patient education can increase engagement of diverse learning styles while simultaneously reducing potential time conflicts in hospital practice. This study contributes to the literature by assessing the effectiveness of discharge education video(s) on patient satisfaction and knowledge levels which are currently limited.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the standard of care arm will be enrolled through a specified date (currently targeting late February 2022, at which time enrolled patients will be included in the intervention group until data collection ceases in late April
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patients in the Standard of Care arm will receive pharmacist discharge education via fully in-person education as is currently being done. |
| Intervention | Experimental | Other: Educational VideosPatients in the Intervention arm will have access to pre-recorded educational videos covering key educational points. Patients will also have in-person interaction with pharmacists to address additional questions not covered in the videos. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are solid organ transplant recipients at Johns Hopkins Hospital
- Patients who are being managed by an adult solid-organ transplant surgical service
- Patients who can speak and read the English language
Key exclusion criteria (2 listed)
- Patients with language access services needs will be excluded
- Patients who do not meet inclusion criteria
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 |
|---|---|---|
| Educational VideosSeries of six videos each covering a specific aspect of post-transplant care related to medication use or monitoring | Other | Intervention |
Primary outcome
Patient Transplant Medication and Care Knowledge
Time frame: Pre- and post-education; pre-education assessment will be completed as soon as feasible after transplant (estimate 1-3 days) and consent; post-education assessment will be completed as soon as is feasible after initial education (estimate 0-2 days)
Change in performance pre and post-education based on responses to questionnaire
Patient Satisfaction with Educational Method
Time frame: As soon as feasible post-education, in concert with post-education knowledge assessment (estimate 0-2 days)
Difference in satisfaction as determined by response to questionnaire post education. A single question score from 1 to 10 will be used, with 10 being highest satisfaction and 1 being the lowest level of satisfaction
1 secondary outcome
Pharmacist Time Requirement
Time frame: As soon as feasible post-education (estimate 0-2 days)
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 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Educational Activities
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Gamified Versus Regular Exercise Snacks on Stationary Bikes, as One 10-Minute or Two 5-Minute Sessions a Day, for Children in an Inclusive Primary School
Exercise, Sedentary Behavior
Active, not recruiting
Physical Activity Education and Quality of Life Study in Breast Cancer Chemotherapy Patients
Breast Cancer
Not yet recruiting
Active Airways for Children and Young People With Asthma
Asthma Childhood, Exercise
Active, not recruiting
Nursing Students' Brain/MS Immersive Three-Dimensional Learning Activity
Multiple Sclerosis
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.
Ryan Whisler principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Videos in people with Educational Activities and Organ Transplants, run by Johns Hopkins University at 1 site in United States.
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 3 inclusion and 2 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 Jun 2022. 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 United States. 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?
Patient Transplant Medication and Care Knowledge (time frame: Pre- and post-education; pre-education assessment will be completed as soon as feasible after transplant (estimate 1-3 days) and consent; post-education assessment will be completed as soon as is feasible after initial education (estimate 0-2 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2022.