NCT03886974

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

March 11, 2019

Last Update Submit

November 7, 2019

Conditions

Keywords

Transition of careSupport networksAdults with Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Needs assessment for transition of care

    Needs assessment questionnaire

    Baseline

Study Arms (3)

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study surveys will be advertised throughout the USA using various online forums specific to diabetes.

You may qualify if:

  • 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

You may not qualify if:

  • Adults with T2D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Study Officials

  • Harsimran Singh, PhD

    Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 22, 2019

Study Start

September 7, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

November 12, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations