Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 2473 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

Psychosocial Functioning in Young Adults With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02874612
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Baylor University
Children's Research Institute
Texas A&M University
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date June 29, 2016
First Posted Date August 22, 2016
Last Update Posted Date February 1, 2019
Study Start Date August 2015
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2016)
Evidence of a correlation between negative diabetes health outcomes and psychosocial functioning over a 1 year period [ Time Frame: 1 year ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02874612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 17, 2016)
  • Number of participants rating themselves as having diabetes resilience as assessed by the Diabetes Resilience Measure (DRMY-YA) measure [ Time Frame: 1 year ]
    Collaborate with Drs. Hilliard and Monaghan on their validation of the Diabetes Resilience (DRMY-YA) measure within a young adult with T1D population.
  • Number of participating rating themselves as having diabetes quality of life as assessed by the PedsQL Diabetes 3.2 measure [ Time Frame: 1 year ]
    Collaborate with Dr. Varni on the validation of the PedsQL Diabetes 3.2 measure within a young adult with T1D population
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychosocial Functioning in Young Adults With Type 1 Diabetes
Official Title Young Adults With Type 1 Diabetes: Psychosocial Influences in Heath Outcomes for Young Adults Transitioning to Adult Care Project
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Type 1 Diabetes Mellitus
Intervention Other: Psychosocial Survey Questionnaires
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.
Study Groups/Cohorts 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.
Intervention: Other: Psychosocial Survey Questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 31, 2019)
47
Original Estimated Enrollment
 (submitted: August 17, 2016)
120
Actual Study Completion Date December 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02874612
Other Study ID Numbers 2015-1575
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Only de-identified data will be shared with the collaborating institutions and is outlined in the consenting process.
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators
  • Baylor University
  • Children's Research Institute
  • Texas A&M University
Investigators
Principal Investigator: Jessica C Kichler, PhD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date January 2019