Parents of Young Adults With Type 1 Diabetes: An Exploratory Study

Type1diabetes Clinical Trial

Official title:

Parents of Young Adults With Type 1 Diabetes: An Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158415
• Other study ID #: IRB201700810
• Secondary ID: 13177
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: July 18, 2017

Study information

• Verified date: February 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this mixed-methods study is to explore the lived experience of parents of young adults ages 18 to 25 years with type 1 diabetes who are transitioning to independence, and to test the preliminary efficacy of a mobile education program to reduce parental distress.

Description:

As young adults with T1D navigate the transition process to independence, they often do so in partnership with their parents, who are tasked with providing support and guidance. At this time, however, no structured education program exists for these parents. In addition, little is known about their learning needs, levels of distress, and readiness to provide appropriate guidance for their emerging adult children. This represents a gap in the literature and an opportunity to undertake exploratory research to learn more about this population so that meaningful education and support can be provided.

Aim 1. To describe the lived experience and diabetes-specific educational needs of parents of young adults with type 1 diabetes who are transitioning to independence.

Aim 2. To measure the effect of a mobile diabetes education program on diabetes distress levels of parents of young adults ages 18 to 25 years who are transitioning to independence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 18, 2017
• Est. primary completion date: July 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• (1) Ability to read and speak English

• (2) parent of a child aged =18 years and =25 years with a diagnosis with T1D

• (3) must have access to a smartphone or tablet or laptop/desktop computer with internet access.

Exclusion Criteria:

• (1) Significant medical comorbidity in the participant that could, in the opinion of the PI, affect participant's capacity to complete study follow up;

• (2) inability to read and speak English.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Parents
• Type1diabetes

Intervention

Behavioral:
• T1DToolkit.org mobile diabetes education
Participants will receive a reminder via text and/or email twice per week to invite them to view diabetes education materials on the study's mobile website, T1DToolkit.org. Topics on this website include, among others, Caregiver Burnout; Your Child is Now an Adult; Sharing Responsibility; Sources of Support; Common Fears for Parents of Young Adults; and Your Child, Your Child's Doctor, and You. Six weeks after enrollment, participants will complete the Modified Diabetes Distress Scale: Parents of Young Adults.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lived experience	The transcripts of the semi-structured interviews will be coded and analyzed using qualitative data content analysis to describe the the lived experience and diabetes-specific educational needs of parents of young adults with type 1 diabetes who are transitioning to independence.	1 week
Secondary	Diabetes Distress	The Modified Diabetes Distress Scale will be used pre- and post-intervention to measure the effect of a brief mobile diabetes education program on diabetes distress levels of parents of young adults ages 18 to 25 years who are transitioning to independence. Higher scores on the Distress Scale indicate higher levels of distress.	6 weeks