Evaluating the Transition From Pediatric to Adult Care Among Adolescents With Chronic Granulomatous Disease

April 4, 2018 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

-INCLUSION CRITERIA:

  1. 18 to 24 years of age during January 1, 2011 to December 31, 2012
  2. Documented diagnosis of CGD

  3. 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
  4. Record of a visit to NIH prior to 18th birthday and at least one visit during January 1, 2011 to December 31, 2012
  5. Health status sufficient to participate in an interview, as determined by patient self-report at the start of the interview.
  6. Fluency in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful transition to adult care
Time Frame: After completion of interview
After completion of interview

Secondary Outcome Measures

Outcome Measure
Time Frame
To explore strategies that young adult patients believe mayenhance the process of transition from pediatric to adult care
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Patricia R Driscoll, R.N., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 26, 2014

Primary Completion (ACTUAL)

January 11, 2016

Study Completion (ACTUAL)

January 10, 2017

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (ESTIMATE)

September 8, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

January 10, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999914088
  • 14-I-N088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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