Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05620251 - Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
Completed NCT03623113 - The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes N/A
Active, not recruiting NCT05078658 - Low-carbohydrate Diet in Children With Type 1 Diabetes N/A
Not yet recruiting NCT06018324 - CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Withdrawn NCT03736083 - Introducing CGM at Type 1 Diabetes Diagnosis N/A
Completed NCT03177096 - Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes N/A
Not yet recruiting NCT06418269 - The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes N/A
Completed NCT04172077 - Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
Recruiting NCT04950634 - Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Completed NCT04450745 - Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients N/A
Completed NCT03165786 - A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes N/A
Terminated NCT04028960 - IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase Phase 2
Recruiting NCT05324488 - Diabetes Registry Graz for Biomarker Research
Completed NCT02984709 - Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes N/A
Completed NCT02984514 - Brown Adipose Tissue in Type 1 Diabetes N/A
Recruiting NCT06372392 - Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps N/A
Recruiting NCT03311516 - New Insulin Therapy by Multiwave Bolus N/A
Recruiting NCT05973799 - Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes N/A
Completed NCT03711656 - Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques N/A
Recruiting NCT05737654 - The Effect of Exercise on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life N/A