Type 1 DiabetesNCT01109797
Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
A study testing Transition Social Behavioral Intervention and Diabetes Transition Clinic in people with Type 1 Diabetes, run by University of Kansas at 1 site in United States.
Trial summary
The purpose of the study is to compare two interventions for preparing diabetic teens and young adults for transition from pediatric to adult diabetes care. Read more about this study
- Who is it for?
- Ages 16 to 29 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Transition Social Behavioral Intervention and Diabetes Transition Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2012
- Phase
- Interventional
- 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 16 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-29
- Diagnosis of type 1 diabetes, or type 2 diabetes managed with insulin, at least one year prior to study initiation
- English-speaking
- Some form of private or public (e.g., Medicaid) health insurance
Who cannot join
- Cystic fibrosis-related or pancreatitis-related diabetes
- Diabetes related to a known specific genetic defect such as Down's Syndrome, Lipoatrophic Diabetes, Leprechaunism or Rabson-Mendenhall Syndrome, etc.
- Chronic liver disease
- History of chronic renal failure
- Serious psychiatric illness that in the judgment of the investigators would preclude the individual's ability to complete the study
- Pregnant or planning to become pregnant within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
The purpose of the study is to compare two interventions for preparing diabetic teens and young adults for transition from pediatric to adult diabetes care.
Read the detailed description
One will represent a short-term intensive social-behavioral intervention supported by peer-to-peer social networking in which subjects receive "usual care" from their current diabetes provider outside the parameters of the study. The second intervention will be a traditional transition clinic model, where subjects will receive the standard of diabetes care from a team of combined pediatric and adult practitioners and educators, with added educational modules and behavioral evaluation and support designed to facilitate the transition to adult care (i.e., that foster "developmentally tailored care"). The first is a much less intensive intervention from the standpoint of the providers and gives special prominence to peer support; the second is provider-intensive. The goal of both interventions is to improve self-efficacy (confidence in taking ownership of and managing one's diabetes); i.e., to prepare the patient to move from primary support by family and providers to a reliance on self-ownership and self-management as a responsible, independent adult.
Optional sub-study available for parents, spouses, and significant others.
- Conditions
- Type 1 Diabetes
- Being tested
- Transition Social Behavioral Intervention, Diabetes Transition Clinic
- 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.
Transition Social Behavioral InterventionBehavioural
If you are assigned to the first group, you will have two all-day Saturday sessions four weeks apart on the KU campus in Lawrence. The objectives of the Saturday programs are to promote positive behavior change with respect to "taking ownership" of diabetes and its demands by providing transition-specific information, enabling participants to practice the life skills needed to successfully manage diabetes as an adult, and fostering peer-to-peer social networking over the 6-month period of the intervention (and beyond). You will continue to see your current provider of diabetes care outside of the parameters of this study.
Diabetes Transition ClinicBehavioural
Patients who participate in the transition clinic arm of the study will be seen six times during a six-month time period, as well as receive psychological assessment and intervention, as necessary, prior to the first clinic visit (intake) and as part of visits 2 and 4. Three of the six visits will be standard of care medical visits with either a pediatric or adult provider or both. Three will be individual or group education sessions with diabetes educators focused on transition issues such as, managing the adult health care system, talking with your care provider,and dealing with adult issues (pregnancy, genetic concerns, etc).
| Study group | Role | What they receive |
|---|---|---|
| Transition Social Behavioral Intervention | Experimental | Not described Receives: Behavioral: Transition Social Behavioral Intervention |
| Diabetes Transition Clinic | Experimental | Not described Receives: Behavioral: Diabetes Transition Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure and compare change in self-efficacy and change in diabetes knowledge, diabetes quality of life, family conflict, and treatment satisfaction for and between the two groups.
Measured: 6 months and 12 months
Secondary outcomes (4)
Make exploratory baseline comparisons between the two groups regarding locus of diabetes care (kind of provider), comparing numbers of subjects in each group who made a successful transition to adult care
Measured: 6 months and 12 months
Make exploratory baseline comparisons between the two groups of using some form of social networking by the two groups as an adjunt of diabetes care.
Measured: 6 months and 12 months
Make exploratory baseline comparisons between the two groups regarding provider and educator time devoted in each arm of the intervention (in order to prepare for a robust comparative effectiveness analysis in a subsequent study).
Measured: 6 months
Make exploratory baseline comparisons between the two groups of HgbA1c
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt Midyett, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109797
- Sponsor's protocol ID
- 12157
- Status last verified
- May 2014
- First submitted
- 19 Apr 2010
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
- ClinicalTrials.gov ID
- NCT01109797
- Acronym / sponsor ID
- 12157
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 Apr 2010 (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.
The purpose of the study is to compare two interventions for preparing diabetic teens and young adults for transition from pediatric to adult diabetes care.
Detailed description
One will represent a short-term intensive social-behavioral intervention supported by peer-to-peer social networking in which subjects receive "usual care" from their current diabetes provider outside the parameters of the study. The second intervention will be a traditional transition clinic model, where subjects will receive the standard of diabetes care from a team of combined pediatric and adult practitioners and educators, with added educational modules and behavioral evaluation and support designed to facilitate the transition to adult care (i.e., that foster "developmentally tailored care"). The first is a much less intensive intervention from the standpoint of the providers and gives special prominence to peer support; the second is provider-intensive. The goal of both interventions is to improve self-efficacy (confidence in taking ownership of and managing one's diabetes); i.e., to prepare the patient to move from primary support by family and providers to a reliance on self-ownership and self-management as a responsible, independent adult.
Optional sub-study available for parents, spouses, and significant others.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transition Social Behavioral Intervention | Experimental | Behavioral: Transition Social Behavioral Intervention |
| Diabetes Transition Clinic | Experimental | Behavioral: Diabetes Transition Clinic |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 16-29
- Diagnosis of type 1 diabetes, or type 2 diabetes managed with insulin, at least one year prior to study initiation
- English-speaking
- Some form of private or public (e.g., Medicaid) health insurance
Key exclusion criteria (6 listed)
- Cystic fibrosis-related or pancreatitis-related diabetes
- Diabetes related to a known specific genetic defect such as Down's Syndrome, Lipoatrophic Diabetes, Leprechaunism or Rabson-Mendenhall Syndrome, etc.
- Chronic liver disease
- History of chronic renal failure
- Serious psychiatric illness that in the judgment of the investigators would preclude the individual's ability to complete the study
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 |
|---|---|---|
| Transition Social Behavioral InterventionIf you are assigned to the first group, you will have two all-day Saturday sessions four weeks apart on the KU campus in Lawrence. The objectives of the Saturday programs are to promote positive behavior change with respect to "taking ownership" of diabetes and its demands by providing transition-specific information, enabling participants to practice the life skills needed to successfully manage diabetes as an adult, and fostering peer-to-peer social networking over the 6-month period of the intervention (and beyond). You will continue to see your current provider of diabetes care outside of the parameters of this study. | Behavioural | Transition Social Behavioral Intervention |
| Diabetes Transition ClinicPatients who participate in the transition clinic arm of the study will be seen six times during a six-month time period, as well as receive psychological assessment and intervention, as necessary, prior to the first clinic visit (intake) and as part of visits 2 and 4. Three of the six visits will be standard of care medical visits with either a pediatric or adult provider or both. Three will be individual or group education sessions with diabetes educators focused on transition issues such as, managing the adult health care system, talking with your care provider,and dealing with adult issues (pregnancy, genetic concerns, etc). | Behavioural | Diabetes Transition Clinic |
Primary outcome
Measure and compare change in self-efficacy and change in diabetes knowledge, diabetes quality of life, family conflict, and treatment satisfaction for and between the two groups.
Time frame: 6 months and 12 months
4 secondary outcomes
Make exploratory baseline comparisons between the two groups regarding locus of diabetes care (kind of provider), comparing numbers of subjects in each group who made a successful transition to adult care
Time frame: 6 months and 12 months
Make exploratory baseline comparisons between the two groups of using some form of social networking by the two groups as an adjunt of diabetes care.
Time frame: 6 months and 12 months
Make exploratory baseline comparisons between the two groups regarding provider and educator time devoted in each arm of the intervention (in order to prepare for a robust comparative effectiveness analysis in a subsequent study).
Time frame: 6 months
Make exploratory baseline comparisons between the two groups of HgbA1c
Time frame: 6 months and 12 months
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 26 May 2014.
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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.
Kurt Midyett, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition Social Behavioral Intervention and Diabetes Transition Clinic in people with Type 1 Diabetes, run by University of Kansas 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 6 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 26 May 2014. 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?
Measure and compare change in self-efficacy and change in diabetes knowledge, diabetes quality of life, family conflict, and treatment satisfaction for and between the two groups. (time frame: 6 months and 12 months). 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 26 May 2014.