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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03886974
Other study ID # 147-18-DI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 7, 2018
Est. completion date October 1, 2019

Study information

Verified date November 2019
Source Hoag Memorial Hospital Presbyterian
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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).


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


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date October 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Adults with T2D

Study Design


Locations

Country Name City State
United States Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian Newport Beach California

Sponsors (1)

Lead Sponsor Collaborator
Hoag Memorial Hospital Presbyterian

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Needs assessment for transition of care Needs assessment questionnaire Baseline
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