Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 2472 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

Transition to Adult Care in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886974
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hoag Memorial Hospital Presbyterian

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).

Condition or disease
Type1diabetes

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


Layout table for study information
Study Type : Observational
Actual Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Transition to Adult Care in Type 1 Diabetes - Understanding Needs, Expectations, and Experiences of Emerging Adults, Parents, and Healthcare Professionals
Actual Study Start Date : September 7, 2018
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
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).



Primary Outcome Measures :
  1. Needs assessment for transition of care [ Time Frame: Baseline ]
    Needs assessment questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study surveys will be advertised throughout the USA using various online forums specific to diabetes.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886974


Locations
Layout table for location information
United States, California
Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Investigators
Layout table for investigator information
Principal Investigator: Harsimran Singh, PhD Mary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian

Layout table for additonal information
Responsible Party: Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier: NCT03886974     History of Changes
Other Study ID Numbers: 147-18-DI
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoag Memorial Hospital Presbyterian:
Transition of care
Support networks
Adults with Type 1 diabetes
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases