Type 1 Diabetes MellitusNCT02874612
Psychosocial Functioning in Young Adults With Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Psychosocial Survey Questionnaires
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2018
- 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 24 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Co-existing diagnosis of mental retardation or pervasive developmental disorder
- Not fluent in the English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Psychosocial Survey Questionnaires
- Keywords
- Young Adults, Psychosocial Functioning
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Survey QuestionnairesOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Psychosocial Survey Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of a correlation between negative diabetes health outcomes and psychosocial functioning over a 1 year period
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.
Measured: 1 year
Secondary outcomes (2)
Number of participants rating themselves as having diabetes resilience as assessed by the Diabetes Resilience Measure (DRMY-YA) measure
Collaborate with Drs. Hilliard and Monaghan on their validation of the Diabetes Resilience (DRMY-YA) measure within a young adult with T1D population.
Measured: 1 year
Number of participating rating themselves as having diabetes quality of life as assessed by the PedsQL Diabetes 3.2 measure
Collaborate with Dr. Varni on the validation of the PedsQL Diabetes 3.2 measure within a young adult with T1D population
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 posted22 Aug 2016 (estimated)
- Study startAug 2015
- Primary completionSep 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor University, Children's National Research Institute, Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Jessica C Kichler, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874612
- Sponsor's protocol ID
- 2015-1575
- Status last verified
- Jan 2019
- First submitted
- 29 Jun 2016
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Only de-identified data will be shared with the collaborating institutions and is outlined in the consenting process.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adults With Type 1 Diabetes: Psychosocial Influences in Heath Outcomes for Young Adults Transitioning to Adult Care Project
- ClinicalTrials.gov ID
- NCT02874612
- Acronym / sponsor ID
- 2015-1575
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Young Adults, Psychosocial Functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Baylor University, Children's National Research Institute, Texas A&M University
- Study start
- Aug 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 22 Aug 2016 (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: 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Adults with Type 1 Diabetes Mellitus | – | Other: Psychosocial Survey QuestionnairesAll 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Co-existing diagnosis of mental retardation or pervasive developmental disorder
- Not fluent in the English language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial Survey QuestionnairesYoung 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. | Other | Young Adults with Type 1 Diabetes Mellitus |
Primary outcome
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.
2 secondary outcomes
Number of participants rating themselves as having diabetes resilience as assessed by the Diabetes Resilience Measure (DRMY-YA) measure
Time frame: 1 year
Number of participating rating themselves as having diabetes quality of life as assessed by the PedsQL Diabetes 3.2 measure
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 1 Feb 2019.
- Individual participant dataSharing planned: Yes. Only de-identified data will be shared with the collaborating institutions and is outlined in the consenting process.
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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.
Jessica C Kichler, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
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 Type 1 Diabetes Mellitus, run by Children's Hospital Medical Center, Cincinnati 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?
The sponsor lists 4 inclusion and 2 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 1 Feb 2019. 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?
Evidence of a correlation between negative diabetes health outcomes and psychosocial functioning over a 1 year period (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2019.