Type1diabetesNCT03886974
Transition to Adult Care in Type 1 Diabetes
An observational study of Type1diabetes, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
Trial summary
Successful transition to an adult diabetes clinic is an essential part of both clinical and psychosocial care for emerging adults with type 1 diabetes (T1D). Pediatric patients are generally very well supported by their parents, significant others, and multidisciplinary clinical care teams, however, these support… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 1 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study surveys will be advertised throughout the USA using various online forums specific to diabetes.
Who may be able to join
- US residents
- Adults with T1D
- Parents of adults with T1D
- Healthcare providers caring for patients with T1D (in a pediatric or an adult care setting)
- Fluent in the English Language
Who cannot join
- Adults with T2D
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
Official title: Transition to Adult Care in Type 1 Diabetes - Understanding Needs, Expectations, and Experiences of Emerging Adults, Parents, and Healthcare Professionals
Successful transition to an adult diabetes clinic is an essential part of both clinical and psychosocial care for emerging adults with type 1 diabetes (T1D). Pediatric patients are generally very well supported by their parents, significant others, and multidisciplinary clinical care teams, however, these support networks tend to change once patients reach adulthood and are required to transition to a more independent clinical care model with their adult care providers. This change can often be an overwhelming adjustment with a potential impact on patient's clinical and psychosocial outcomes. As part of the proposed mixed methods study, in Phase 1, the investigators will develop online questionnaires for primary stakeholders in the transition process to improve understanding of their needs, expectations, and experiences around transition. Based on findings from Phase 1, up to 30 individuals from each of the six groups will be interviewed to discuss their responses and better understand their needs around the transition process (Phase 2). Subsequently, findings from the qualitative analyses of the semi-structured interviews will inform the preparation of recommendations that may help facilitate a successful transition for the various stakeholder groups (Phase 3).
Read the detailed description
The proposed study has been designed to understand needs, expectations, and experiences of emerging adults, parents, and healthcare providers who have or currently are involved in the transition process in T1D. Although, a few previous studies have focused on exploring these aspects of the transition process, these have mostly been at a regional level focusing on a few clinics instead of an attempt to capture responses at a national level. Additionally, as part of this study, each responding stakeholder participant will be requested to invite other other stakeholder group members who they might know to complete the questionnaire (e.g. a T1D patient sharing study information with their parents and their endocrinologist). This would allow the investigators to get a comprehensive picture of the transition process. The study consists of three phases including an online questionnaire (specific to each stakeholder group) (Phase 1), semi-structured phone interviews with a few participants from each stakeholder participant group (Phase 2), and subsequently, developing recommendations for a transition process that aligns the needs and expectations of the various stakeholder groups (Phase 3).
This project has the potential to highlight T1D patients', their families, and providers' concerns and expectations regarding the transition process from a national sample which, could help develop recommendations to implement a patient-centered, successful transition process for emerging adults with T1D.
Specific aims:
Phase 1: To explore needs, expectations, and experiences of emerging adults with T1D, their parents, and healthcare providers around the transition process.
Phase 2: To conduct semi-structured interviews with participants from three stakeholder groups for in-depth understanding of the issues related to the transition process
Phase 3: To develop recommendations for a patient-centered transition process for emerging adults with T1D
- Conditions
- Type1diabetes
- Keywords
- Transition of care, Support networks, Adults with Type 1 diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with type 1 diabetes | People with T1D who are 18 years or older. | |
| Parents of adults with type 1 diabetes | Parents who have adult children with type 1 diabetes. | |
| Healthcare providers managing patients with type 1 diabetes | Licensed healthcare providers who are managing patients with T1D (whether in adult or pediatric practice). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needs assessment for transition of care
Needs assessment questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start7 Sep 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harsimran Singh, PhD, Principal investigator, Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886974
- Sponsor's protocol ID
- 147-18-DI
- Status last verified
- Nov 2019
- First submitted
- 11 Mar 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- 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 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition to Adult Care in Type 1 Diabetes - Understanding Needs, Expectations, and Experiences of Emerging Adults, Parents, and Healthcare Professionals
- ClinicalTrials.gov ID
- NCT03886974
- Acronym / sponsor ID
- 147-18-DI
- Conditions
- Type1diabetes
- Keywords
- Transition of care, Support networks, Adults with Type 1 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 22 Mar 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.
Successful transition to an adult diabetes clinic is an essential part of both clinical and psychosocial care for emerging adults with type 1 diabetes (T1D). Pediatric patients are generally very well supported by their parents, significant others, and multidisciplinary clinical care teams, however, these support networks tend to change once patients reach adulthood and are required to transition to a more independent clinical care model with their adult care providers. This change can often be an overwhelming adjustment with a potential impact on patient's clinical and psychosocial outcomes. As part of the proposed mixed methods study, in Phase 1, the investigators will develop online questionnaires for primary stakeholders in the transition process to improve understanding of their needs, expectations, and experiences around transition. Based on findings from Phase 1, up to 30 individuals from each of the six groups will be interviewed to discuss their responses and better understand their needs around the transition process (Phase 2). Subsequently, findings from the qualitative analyses of the semi-structured interviews will inform the preparation of recommendations that may help facilitate a successful transition for the various stakeholder groups (Phase 3).
Detailed description
The proposed study has been designed to understand needs, expectations, and experiences of emerging adults, parents, and healthcare providers who have or currently are involved in the transition process in T1D. Although, a few previous studies have focused on exploring these aspects of the transition process, these have mostly been at a regional level focusing on a few clinics instead of an attempt to capture responses at a national level. Additionally, as part of this study, each responding stakeholder participant will be requested to invite other other stakeholder group members who they might know to complete the questionnaire (e.g. a T1D patient sharing study information with their parents and their endocrinologist). This would allow the investigators to get a comprehensive picture of the transition process. The study consists of three phases including an online questionnaire (specific to each stakeholder group) (Phase 1), semi-structured phone interviews with a few participants from each stakeholder participant group (Phase 2), and subsequently, developing recommendations for a transition process that aligns the needs and expectations of the various stakeholder groups (Phase 3).
This project has the potential to highlight T1D patients', their families, and providers' concerns and expectations regarding the transition process from a national sample which, could help develop recommendations to implement a patient-centered, successful transition process for emerging adults with T1D.
Specific aims:
Phase 1: To explore needs, expectations, and experiences of emerging adults with T1D, their parents, and healthcare providers around the transition process.
Phase 2: To conduct semi-structured interviews with participants from three stakeholder groups for in-depth understanding of the issues related to the transition process
Phase 3: To develop recommendations for a patient-centered transition process for emerging adults with T1D
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults with type 1 diabetes | – | –People with T1D who are 18 years or older. |
| Parents of adults with type 1 diabetes | – | –Parents who have adult children with type 1 diabetes. |
| Healthcare providers managing patients with type 1 diabetes | – | –Licensed healthcare providers who are managing patients with T1D (whether in adult or pediatric practice). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study surveys will be advertised throughout the USA using various online forums specific to diabetes.
Key inclusion criteria (5 listed)
- US residents
- Adults with T1D
- Parents of adults with T1D
- Healthcare providers caring for patients with T1D (in a pediatric or an adult care setting)
- Fluent in the English Language
Key exclusion criteria (1 listed)
- Adults with T2D
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Needs assessment for transition of care
Time frame: Baseline
Needs assessment questionnaire
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 12 Nov 2019.
- 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.
Harsimran Singh, PhD principal investigator
Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian
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 Type1diabetes, run by Hoag Memorial Hospital Presbyterian 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 5 inclusion and 1 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 12 Nov 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?
Needs assessment for transition of care (time frame: Baseline). 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 12 Nov 2019.