Organ TransplantationNCT01370746
Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation
An observational study of Organ Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
Trial summary
In this study, doctors will observe how and when pediatric patients who have received a solid organ transplant take their prescribed medication, and determining if there are reasons that keep these patients from taking all of their medicine. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Organ Transplantation
- How many people
- 502 participants
- Where
- 15 sitesUnited States
- Study dates
- Apr 2012to Apr 2014
- Phase
- Observational
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents and pediatric patients after solid organ transplantation (heart, liver, or lung)
Who may be able to join
- Subject and/or guardian must be able to understand and provide informed consent/assent in English or Spanish
- Male or female primary solid organ transplant patients 0-21 years of age
- Recipients at least 1 month post-transplant hospital discharge
Who cannot join
- Inability or unwillingness of a participant or parent/guardian to give informed consent or comply with study protocol
- Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the questionnaires
- Re-transplant recipient
- Multi-organ transplant recipient
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Emory Children's Center
Atlanta, Georgia, 30322
University of Alabama
Birmingham, Alabama, 35233
Children's Hospital of Boston
Boston, Massachusetts, 02115
The Cleveland Clinic
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Florida Health Sciences Center
Gainesville, Florida, 32610
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Ronald Reagan UCLA Medical Center (Mattel Childrens')
Los Angeles, California, 90095-1752
Children's Hospital of New York
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15224
University of California San Francisco Children's Hospital
San Francisco, California, 94143
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105-0371
Washington University School of Medicine
St Louis, Missouri, 63110
Lucile Packard Children's Hospital at Stanford
Stanford, California, 94305
About this study
Official title: Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation (CTOTC-05)
In this study, doctors will observe how and when pediatric patients who have received a solid organ transplant take their prescribed medication, and determining if there are reasons that keep these patients from taking all of their medicine.
Read the detailed description
Adhering to treatment regimens after solid organ transplantation is critical for the prevention of complications, including acute and chronic organ rejection. It is important to recognize the perceived barriers to following treatment regimens and identify ways to address these barriers early in the course of treatment.
- Conditions
- Organ Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Sectional Study Group | Cross-sectional comparison of perceived barriers to adherence to post-transplant immunosuppressant regimens in parents/legal guardians of children 0-11 years versus adolescents 12-21 years | |
| Longitudinal Study Group | Subset of Cross-Sectional Study Group to evaluate whether perceived barriers to adherence increase with time during the first year following transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
Measured: 1 month post transplant
Change in perceived barriers to adherence from baseline to follow-up
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
Measured: 12 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
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 Organ TransplantationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation in Children
- Responsible party
- Sponsor
- Investigators
- Stuart Sweet, MD, PhD, Principal investigator, Washington University School of MedicineLara Danziger-Isakov, MD, MPH, Study chair, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370746
- Sponsor's protocol ID
- DAIT CTOTC-05
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2011
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shemesh E. Barriers to adherence - To screen or not to screen, that is the question. Pediatr Transplant. 2016 Mar;20(2):188-90. doi: 10.1111/petr.12671. Epub 2016 Jan 22. No abstract available.
PubMed 26799519Danziger-Isakov L, Frazier TW, Worley S, Williams N, Shellmer D, Dharnidharka VR, Gupta NA, Ikle D, Sweet SC; CTOTC-05 Consortium. Perceived barriers to medication adherence in pediatric and adolescent solid organ transplantation. Pediatr Transplant. 2016 Mar;20(2):307-15. doi: 10.1111/petr.12648. Epub 2015 Dec 16.
PubMed 26670870
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation (CTOTC-05)
- ClinicalTrials.gov ID
- NCT01370746
- Acronym / sponsor ID
- DAIT CTOTC-05
- Conditions
- Organ Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation in Children
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jun 2011 (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.
In this study, doctors will observe how and when pediatric patients who have received a solid organ transplant take their prescribed medication, and determining if there are reasons that keep these patients from taking all of their medicine.
Detailed description
Adhering to treatment regimens after solid organ transplantation is critical for the prevention of complications, including acute and chronic organ rejection. It is important to recognize the perceived barriers to following treatment regimens and identify ways to address these barriers early in the course of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-Sectional Study Group | – | –Cross-sectional comparison of perceived barriers to adherence to post-transplant immunosuppressant regimens in parents/legal guardians of children 0-11 years versus adolescents 12-21 years |
| Longitudinal Study Group | – | –Subset of Cross-Sectional Study Group to evaluate whether perceived barriers to adherence increase with time during the first year following transplantation |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents and pediatric patients after solid organ transplantation (heart, liver, or lung)
Key inclusion criteria (3 listed)
- Subject and/or guardian must be able to understand and provide informed consent/assent in English or Spanish
- Male or female primary solid organ transplant patients 0-21 years of age
- Recipients at least 1 month post-transplant hospital discharge
Key exclusion criteria (4 listed)
- Inability or unwillingness of a participant or parent/guardian to give informed consent or comply with study protocol
- Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the questionnaires
- Re-transplant recipient
- Multi-organ transplant recipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients
Time frame: 1 month post transplant
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
Change in perceived barriers to adherence from baseline to follow-up
Time frame: 12 months post transplant
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
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 5 Jun 2017.
- Background: PubMed 26799519Shemesh E. Barriers to adherence - To screen or not to screen, that is the question. Pediatr Transplant. 2016 Mar;20(2):188-90. doi: 10.1111/petr.12671. Epub 2016 Jan 22. No abstract available.
- Results publication: PubMed 26670870Danziger-Isakov L, Frazier TW, Worley S, Williams N, Shellmer D, Dharnidharka VR, Gupta NA, Ikle D, Sweet SC; CTOTC-05 Consortium. Perceived barriers to medication adherence in pediatric and adolescent solid organ transplantation. Pediatr Transplant. 2016 Mar;20(2):307-15. doi: 10.1111/petr.12648. Epub 2015 Dec 16.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Clinical Trials in Organ Transplantation in Children (CTOT-C)Link 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.
Stuart Sweet, MD, PhD principal investigator
Washington University School of Medicine
Lara Danziger-Isakov, MD, MPH study chair
Children's Hospital Medical Center, Cincinnati
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites 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 4 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients (time frame: 1 month post transplant). 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?
On the ClinicalTrials.gov record for NCT01370746, 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 5 Jun 2017.