Type 1 DiabetesNCT03998475
Transition Preparation Intervention for Young Adults With Type 1 Diabetes
A study testing Transition preparation intervention in people with Type 1 Diabetes, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to find out more about how to support young adults (ages 18-22) with type 1 diabetes as they prepare to transition from pediatric and adult endocrinology medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Transition preparation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 16 Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both members of the youth/parent dyad must meet all eligibility criteria
- Young adults
- English-speaking
- patients in Pediatric Endocrinology at Children's Hospital of Richmond (CHoR) at Virginia Commonwealth University (VCU)
- between ages 18-22 yrs with a
- diagnosis of T1D for >1 year
Show all 12Show fewer
- Parents
- greater than 18 years of age
- provide care to the young adult with T1D
- are willing to participate in the intervention
- Medical providers
- provide care to patients with T1D ages 18-22 yrs in Pediatric Endocrinology at CHoR
Who cannot join
- Young adults
- significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability), as documented in the medical record or revealed during eligibility screening, or
- medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes
- Parents
- non-English speaking
- psychiatric, cognitive, or developmental conditions that would impair their ability to complete assessments and/or engage in the intervention as determined at study screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Richmond at Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Implementing a Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting
The purpose of this research study is to find out more about how to support young adults (ages 18-22) with type 1 diabetes as they prepare to transition from pediatric and adult endocrinology medical care.
Read the detailed description
The overarching goal of the proposed trial is to improve diabetes self-management and glycemic control in young adults and prepare them for the transition to adult endocrinology. The current application will investigate the impact of a multisystem transition preparation intervention for young adults (ages 18-22) with T1D. Twenty-five young adults and a parent will be enrolled in a 6-month transition preparation program which will use a hybrid in-person and technology delivery structure. Providers will receive training highlighting their role preparing young adults for transition and provides practical tips to use in their communication with young adults. If effective, this multisystem intervention, designed to enhance T1D self-management and increase young adults' readiness for transition to adult healthcare during this critical developmental period, has the potential to inform clinical practice guidelines.
- Conditions
- Type 1 Diabetes
- Being tested
- Transition preparation intervention
- Keywords
- Transition, Young Adult
- 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 preparation interventionBehavioural
Young adult participants and parents will complete transition preparation sessions that include meeting with a health behavior coach for in-person sessions and review of materials sent electronically between study visits.
| Study group | Role | What they receive |
|---|---|---|
| Transition preparation program | Experimental | Transition preparation intervention for young adults with type 1 diabetes (T1D) Receives: Behavioral: Transition preparation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions attended
Number of study visits (attendance)
Measured: 6 months
Number of session views
Number of opened electronic materials (e.g., opened messages in the patient health portal))
Measured: 6 months
Program acceptability - young adult
Young adult report on satisfaction with the program via an exit survey
Measured: 9 months
Program acceptability - parent
Parent report on satisfaction with the program via an exit survey
Measured: 9 months
Program acceptability - provider
Provider report on satisfaction with the program via an exit survey
Measured: 9 months
Secondary outcomes (4)
Change in Glycemic control
Measurement of hemoglobin A1c (A1c; reported as a percentage)
Measured: Baseline to 9 months
Diabetes-related hospitalizations
Participant report and medical record review of count of reported diabetes-related hospitalizations and complications
Measured: 9 months
Change in adherence to diabetes care regimen
Average of young adult and parent participant reports on the Diabetes Management Questionnaire (DMQ)
Measured: Baseline to 9 months
Change in transition readiness
Average of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ)
Measured: Baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start11 Jul 2019
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Laura Caccavale, PhD, Principal investigator, Virginia Commonwealth UniversityMelanie Melanie, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998475
- Sponsor's protocol ID
- HM20015399
- Other IDs
- 1-19-PDF-041-R
- Status last verified
- Nov 2020
- First submitted
- 24 Jun 2019
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting
- ClinicalTrials.gov ID
- NCT03998475
- Acronym / sponsor ID
- HM20015399
- Conditions
- Type 1 Diabetes
- Keywords
- Transition, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 26 Jun 2019 (actual)
- 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 this research study is to find out more about how to support young adults (ages 18-22) with type 1 diabetes as they prepare to transition from pediatric and adult endocrinology medical care.
Detailed description
The overarching goal of the proposed trial is to improve diabetes self-management and glycemic control in young adults and prepare them for the transition to adult endocrinology. The current application will investigate the impact of a multisystem transition preparation intervention for young adults (ages 18-22) with T1D. Twenty-five young adults and a parent will be enrolled in a 6-month transition preparation program which will use a hybrid in-person and technology delivery structure. Providers will receive training highlighting their role preparing young adults for transition and provides practical tips to use in their communication with young adults. If effective, this multisystem intervention, designed to enhance T1D self-management and increase young adults' readiness for transition to adult healthcare during this critical developmental period, has the potential to inform clinical practice guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transition preparation program | Experimental | Behavioral: Transition preparation interventionTransition preparation intervention for young adults with type 1 diabetes (T1D) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Both members of the youth/parent dyad must meet all eligibility criteria
- Young adults
- English-speaking
- patients in Pediatric Endocrinology at Children's Hospital of Richmond (CHoR) at Virginia Commonwealth University (VCU)
- between ages 18-22 yrs with a
Key exclusion criteria (6 listed)
- Young adults
- significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability), as documented in the medical record or revealed during eligibility screening, or
- medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes
- Parents
- non-English speaking
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 preparation interventionYoung adult participants and parents will complete transition preparation sessions that include meeting with a health behavior coach for in-person sessions and review of materials sent electronically between study visits. | Behavioural | Transition preparation program |
Primary outcome
Number of sessions attended
Time frame: 6 months
Number of study visits (attendance)
Number of session views
Time frame: 6 months
Number of opened electronic materials (e.g., opened messages in the patient health portal))
Program acceptability - young adult
Time frame: 9 months
Young adult report on satisfaction with the program via an exit survey
Program acceptability - parent
Time frame: 9 months
Parent report on satisfaction with the program via an exit survey
Program acceptability - provider
Time frame: 9 months
Provider report on satisfaction with the program via an exit survey
4 secondary outcomes
Change in Glycemic control
Time frame: Baseline to 9 months
Diabetes-related hospitalizations
Time frame: 9 months
Change in adherence to diabetes care regimen
Time frame: Baseline to 9 months
Change in transition readiness
Time frame: Baseline to 9 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 9 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Laura Caccavale, PhD principal investigator
Virginia Commonwealth University
Melanie Melanie, PhD principal investigator
Virginia Commonwealth University
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 preparation intervention in people with Type 1 Diabetes, run by Virginia Commonwealth University 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 12 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 9 Nov 2020. 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?
Number of sessions attended (time frame: 6 months). The study lists 5 primary outcomes in all. 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 9 Nov 2020.