CGDNCT02233036
Evaluating the Transition From Pediatric to Adult Care Among Adolescents With Chronic Granulomatous Disease
An observational study of CGD, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: People who get chronic illnesses as children are living longer. When they turn 18, they switch from pediatric care to adult care. This can be a difficult change. Chronic Granulomatous Disease (CGD) is an inherited disease. It causes long-term, repeated infections. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- CGD
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2014to 10 Jan 2017
- 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 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
-INCLUSION CRITERIA:
- 18 to 24 years of age during January 1, 2011 to December 31, 2012
- Documented diagnosis of CGD
- Enrolled in one of the following three NIAID protocols that investigate CGD (and other immunodeficiencies):
- Detection and Characterization of Host Defense Defects (93-I-0119), PI: Dr. Steven Holland
- Screening and Baseline Assessment of Patients with Abnormalities of Immune Function (05-I-0213), PI: Dr. Harry Malech
- Screening Protocol for Detection and Characterization of Infections and Infection (07-I-0033), PI: Dr. Steven Holland
- Record of a visit to NIH prior to 18th birthday and at least one visit during January 1, 2011 to December 31, 2012
- Health status sufficient to participate in an interview, as determined by patient self-report at the start of the interview.
- Fluency in English
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi
Bethesda, Maryland, 20892
About this study
Background:
People who get chronic illnesses as children are living longer. When they turn 18, they switch from pediatric care to adult care. This can be a difficult change. Chronic Granulomatous Disease (CGD) is an inherited disease. It causes long-term, repeated infections. People with CGD are usually diagnosed when they are very young children. Researchers want to find out more about how young people with CGD handle the change to adult care. What they learn may make this easier for people with CGD in the future.
Read more
Objective:
- To identify what helped or hurt young adults with CGD as they went from pediatric to adult care.
Eligibility:
- Adults with CGD who were 18 24 years old between January 2011 and February 2014.
Design:
- Participants will already be enrolled in NIH studies.
- Eligible people will get materials in the mail. They will get a letter with study information, an interview questionnaire, and an information sheet.
- Researchers will call participants 1 week after the packets are sent. They will talk about the study and find out if the person wants to join.
- An interview will be completed immediately or scheduled for the future. The interview will take about 45 minutes. The researcher will ask the participant about their disease. They will also ask about travel to NIH, being an outpatient or inpatient there, and legal documents.
- Researchers may contact the subjects again by phone if they need more information at any point during the study.
Read the detailed description
Children with chronic illnesses are thriving well into adulthood due to ongoing medical advances. Many healthy and typically developing 18-year-olds should be able to manage a transition from pediatric to adult care, but this transition can be challenging for adolescents with chronic illness. A poor transition to adult care can result in medical, social and educational issues for patients, families and the medical team. At issue are questions of independence and self-management: are young adult patients prepared to travel to NIH alone? Are they prepared to speak with physicians about their disease process and medications? Are they ready to give informed consent for studies in which they have been participating?
The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) has several hundred adolescents enrolled in clinical trials, many of whom rely on NIH providers for specialized care. No formal program exists to assist these patients in the transition from pediatric to adult care. Pediatric inpatients are admitted to the adult inpatient unit when they turn 18 with little knowledge of the policy differences between the units.
The investigators propose a retrospective exploratory descriptive study to (a) identify and describe experiences that young adults found to enable or hinder their transition and (b) explore these patients ideas for enhancing the transition process. A semi-structured questionnaire administered by phone or face to face to approximately 40 young adults with chronic granulomatous disease (CGD) will gather qualitative and quantitative information about the use of inpatient and outpatient services at the NIH Clinical Center prior to and since the subjects 18th birthdays. Data will be used to develop a program to help NIAID pediatric patients with CGD transition successfully to adult care.
- Conditions
- CGD
- Keywords
- Young Adults, Transfer, Chronic Disease
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful transition to adult care
Measured: After completion of interview
Secondary outcomes (1)
To explore strategies that young adult patients believe mayenhance the process of transition from pediatric to adult care
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study start26 Mar 2014
- Primary completion11 Jan 2016
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CGDStudies 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
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Patricia R Driscoll, R.N., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233036
- Sponsor's protocol ID
- 999914088
- Other IDs
- 14-I-N088
- Status last verified
- 10 Jan 2017
- First submitted
- 4 Sep 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Fernandes SM, Landzberg MJ. Transitioning the young adult with congenital heart disease for life-long medical care. Pediatr Clin North Am. 2004 Dec;51(6):1739-48, xi. doi: 10.1016/j.pcl.2004.07.006.
PubMed 15561183Kennedy A, Sloman F, Douglass JA, Sawyer SM. Young people with chronic illness: the approach to transition. Intern Med J. 2007 Aug;37(8):555-60. doi: 10.1111/j.1445-5994.2007.01440.x.
PubMed 17640188Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
PubMed 20040605
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Transition From Pediatric to Adult Care Among Adolescents With Chronic Granulomatous Disease
- ClinicalTrials.gov ID
- NCT02233036
- Acronym / sponsor ID
- 999914088
- Conditions
- CGD
- Keywords
- Young Adults, Transfer, Chronic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 26 Mar 2014
- Primary completion
- 11 Jan 2016 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 8 Sep 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.
Background:
People who get chronic illnesses as children are living longer. When they turn 18, they switch from pediatric care to adult care. This can be a difficult change. Chronic Granulomatous Disease (CGD) is an inherited disease. It causes long-term, repeated infections. People with CGD are usually diagnosed when they are very young children. Researchers want to find out more about how young people with CGD handle the change to adult care. What they learn may make this easier for people with CGD in the future.
Objective:
- To identify what helped or hurt young adults with CGD as they went from pediatric to adult care.
Eligibility:
- Adults with CGD who were 18 24 years old between January 2011 and February 2014.
Design:
- Participants will already be enrolled in NIH studies.
- Eligible people will get materials in the mail. They will get a letter with study information, an interview questionnaire, and an information sheet.
- Researchers will call participants 1 week after the packets are sent. They will talk about the study and find out if the person wants to join.
- An interview will be completed immediately or scheduled for the future. The interview will take about 45 minutes. The researcher will ask the participant about their disease. They will also ask about travel to NIH, being an outpatient or inpatient there, and legal documents.
- Researchers may contact the subjects again by phone if they need more information at any point during the study.
Detailed description
Children with chronic illnesses are thriving well into adulthood due to ongoing medical advances. Many healthy and typically developing 18-year-olds should be able to manage a transition from pediatric to adult care, but this transition can be challenging for adolescents with chronic illness. A poor transition to adult care can result in medical, social and educational issues for patients, families and the medical team. At issue are questions of independence and self-management: are young adult patients prepared to travel to NIH alone? Are they prepared to speak with physicians about their disease process and medications? Are they ready to give informed consent for studies in which they have been participating?
The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) has several hundred adolescents enrolled in clinical trials, many of whom rely on NIH providers for specialized care. No formal program exists to assist these patients in the transition from pediatric to adult care. Pediatric inpatients are admitted to the adult inpatient unit when they turn 18 with little knowledge of the policy differences between the units.
The investigators propose a retrospective exploratory descriptive study to (a) identify and describe experiences that young adults found to enable or hinder their transition and (b) explore these patients ideas for enhancing the transition process. A semi-structured questionnaire administered by phone or face to face to approximately 40 young adults with chronic granulomatous disease (CGD) will gather qualitative and quantitative information about the use of inpatient and outpatient services at the NIH Clinical Center prior to and since the subjects 18th birthdays. Data will be used to develop a program to help NIAID pediatric patients with CGD transition successfully to adult care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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
Successful transition to adult care
Time frame: After completion of interview
1 secondary outcome
To explore strategies that young adult patients believe mayenhance the process of transition from pediatric to adult care
Time frame: 1 year
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 Apr 2018.
- Background: PubMed 15561183Fernandes SM, Landzberg MJ. Transitioning the young adult with congenital heart disease for life-long medical care. Pediatr Clin North Am. 2004 Dec;51(6):1739-48, xi. doi: 10.1016/j.pcl.2004.07.006.
- Background: PubMed 17640188Kennedy A, Sloman F, Douglass JA, Sawyer SM. Young people with chronic illness: the approach to transition. Intern Med J. 2007 Aug;37(8):555-60. doi: 10.1111/j.1445-5994.2007.01440.x.
- Background: PubMed 20040605Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
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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.
Patricia R Driscoll, R.N. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CGD, run by National Institute of Allergy and Infectious Diseases (NIAID) 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?
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 Apr 2018. 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?
Successful transition to adult care (time frame: After completion of interview). 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 NCT02233036, which also lists 3 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 Apr 2018.