Lung TransplantationNCT02177916
Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation
A study testing Education in people with Lung Transplantation, run by Tampa General Hospital at 1 site in United States.
Trial summary
The Lung Transplant Team at Tampa General Hospital has identified a need to improve both the quality and quantity of the education that is provided to patients listed for lung transplantation. We propose to change the method and timing of our transplant patient education. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2016
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age- 18-75
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: "A Comparison of 2 Different Methods of Patient Education to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation"
The Lung Transplant Team at Tampa General Hospital has identified a need to improve both the quality and quantity of the education that is provided to patients listed for lung transplantation. We propose to change the method and timing of our transplant patient education. The objective of this prospective data collection will be to collect and analyze pre and post test scores of patients when patient education is provided via compact disc as compared to individualized teaching.
- Conditions
- Lung Transplantation
- Being tested
- Education
- Keywords
- lung transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
| Study group | Role | What they receive |
|---|---|---|
| Traditional teaching | Experimental | Not described Receives: Other: Education |
| DVD | Experimental | Not described Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of patient education when provided via compact disk as compared to individualized teaching as assessed by pre and post test scores.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Rolfe, MD, Principal investigator, Tampa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177916
- Sponsor's protocol ID
- TGH0004
- Status last verified
- Nov 2015
- First submitted
- 26 Jun 2014
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Comparison of 2 Different Methods of Patient Education to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation"
- ClinicalTrials.gov ID
- NCT02177916
- Acronym / sponsor ID
- TGH0004
- Conditions
- Lung Transplantation
- Keywords
- lung transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tampa General HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- First posted
- 30 Jun 2014 (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.
The Lung Transplant Team at Tampa General Hospital has identified a need to improve both the quality and quantity of the education that is provided to patients listed for lung transplantation. We propose to change the method and timing of our transplant patient education. The objective of this prospective data collection will be to collect and analyze pre and post test scores of patients when patient education is provided via compact disc as compared to individualized teaching.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional teaching | Experimental | Other: Education |
| DVD | Experimental | Other: Education |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age- 18-75
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Education | Other | DVD, Traditional teaching |
Primary outcome
Effectiveness of patient education when provided via compact disk as compared to individualized teaching as assessed by pre and post test scores.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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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.
Mark Rolfe, MD principal investigator
Tampa 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 Education in people with Lung Transplantation, run by Tampa General Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Nov 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brenda Farlow, RN (813-844-3430, bfarlow@tgh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of patient education when provided via compact disk as compared to individualized teaching as assessed by pre and post test scores. (time frame: 1 month). 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 10 Nov 2015.