- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02874612
Psychosocial Functioning in Young Adults With Type 1 Diabetes
January 31, 2019 updated by: Children's Hospital Medical Center, Cincinnati
Young Adults With Type 1 Diabetes: Psychosocial Influences in Heath Outcomes for Young Adults Transitioning to Adult Care Project
Background: The often studied psychosocial correlates that relate to health outcomes in adolescents with Type 1 Diabetes (T1D) are factors such as self-efficacy, depression, distress, quality of life, and adherence.
These psychosocial factors are not well-studied within a young adult (YA) population and the parents of YAs during the transition planning phase.
Impact: This study aids program development for pre-transfer educational interventions to ensure more successful post-transfer health outcomes from both a patient and parent perspective.
Methods: This longitudinal study is designed to characterize the psychosocial factors relevant for a population of YA with T1D.
Data analyses of these psychosocial and transition readiness variables allow for understanding of prospective health outcomes for young adults with T1D during the transition process.
Implications/Future Directions: From a clinical perspective, the outcomes of this feasibility study will be two-fold: (1) establish which of the clinical measures used in the study are related to meaningful health outcomes in this young adult population in order to determine future standardized assessments in the Diabetes Center and (2) determine which psychosocial constructs are relevant to health outcomes to then more fully develop the Diabetes Center's transition program interventions to improve functioning clinic-wide (e.g., group day sessions).
Finally, it would be attractive to various National Institutes of Diabetes and Digestive and Kidney Disorder (NIDDK) grant mechanisms to identify the relevant psychosocial measures that assess the psychosocial functioning of YA with diabetes after they transfer to adult care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to assess how psychosocial functioning and transition readiness (health knowledge and self-reported health-related skills) of young adults (aged 18-24) with Type 1 Diabetes (T1D) and their parents impact health outcomes before they transition to adult diabetes care.
Transition of health care from pediatric to adult care systems is a complex process and is often a challenge for young adults.
These transition barriers lead to gaps in healthcare, worsening of glycemic control, and increased hospitalizations/emergency room utilization.
Initial program development efforts to prepare young adults for transition were developed at Cincinnati Children's Hospital Medical Center (CCHMC) based on best practice recommendations in the literature.
The psychosocial correlates of health outcomes in this population are not well studied, though.
Nor is it known whether these diabetes education interventions impact transition to adult care over time.
The investigators will study how psychosocial factors (e.g., self-efficacy, depression, distress, quality of life, adherence, and risky behaviors) impact health outcomes (e.g., glycemic control) over a one year period, within the context of the current diabetes education transition program at Cincinnati Children's Hospital Medical Center (CCHMC) for young adults with T1D and their parents.
Study Type
Observational
Enrollment (Actual)
47
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
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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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 24 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All YA (ages 18-24) who are seen in the CCHMC Diabetes Clinic and have recently (< 4 months) completed the READdY assessment tool as part of their standard clinical care is eligible for the study.
In addition, the YA will need to be planning to stay at CCHMC (i.e., not imminently being transferring their diabetes care to an adult provider) for the next 12 months.
Description
Inclusion Criteria:
- Young Adults ages 18-24
- Current patients of the Cincinnati Children's Hospital Medical Center (CCHMC) Diabetes Clinic
- Recently (< 4 months) completed the Readiness Assessment tool
- Planning to continue to receive diabetes services at CCHMC (i.e., not imminently being transferring their diabetes care to an adult provider) for the next 12 months.
Exclusion Criteria:
- Co-existing diagnosis of mental retardation or pervasive developmental disorder
- Not fluent in the English language.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Young Adults with Type 1 Diabetes Mellitus
All YA (ages 18-24) who are seen in the Cincinnati Children's Hospital Medical Center Diabetes Clinic and have recently (< 4 months) completed the Transition Readiness assessment tool as part of their standard clinical care is eligible for the study.
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Young adults with Type 1 Diabetes Mellitus will be invited to participate in a observational study in which they complete psychosocial measures immediately after completing a readiness transition survey and then again 1 year later.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of a correlation between negative diabetes health outcomes and psychosocial functioning over a 1 year period
Time Frame: 1 year
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Establish if and how the baseline psychosocial and transition readiness constructs relate to long-term health outcomes for young adults with T1D, over a 1 year time frame, which will guide future education interventions and anticipatory guidance for young adults transitioning to adult diabetes care.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants rating themselves as having diabetes resilience as assessed by the Diabetes Resilience Measure (DRMY-YA) measure
Time Frame: 1 year
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Collaborate with Drs.
Hilliard and Monaghan on their validation of the Diabetes Resilience (DRMY-YA) measure within a young adult with T1D population.
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1 year
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Number of participating rating themselves as having diabetes quality of life as assessed by the PedsQL Diabetes 3.2 measure
Time Frame: 1 year
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Collaborate with Dr. Varni on the validation of the PedsQL Diabetes 3.2 measure within a young adult with T1D population
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jessica C Kichler, PhD, Children's Hospital Medical Center, Cincinnati
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
August 1, 2015
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
August 17, 2016
First Posted (Estimate)
August 22, 2016
Study Record Updates
Last Update Posted (Actual)
February 1, 2019
Last Update Submitted That Met QC Criteria
January 31, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-1575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Only de-identified data will be shared with the collaborating institutions and is outlined in the consenting process.
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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