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

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ClinicalTrials.gov Identifier: NCT03158415
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
University of South Florida
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Type1diabetes Parents Behavioral: T1DToolkit.org mobile diabetes education Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Mixed Methods Exploratory Study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Parents of Young Adults With Type 1 Diabetes: An Exploratory Study
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : July 18, 2017
Actual Study Completion Date : July 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Parents of Young Adults with T1D
Parents of young adults ages 18 to 25 years with type 1 diabetes who are transitioning to independence. During six weeks, 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.
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.





Primary Outcome Measures :
  1. Lived experience [ Time Frame: 1 week ]
    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.


Secondary Outcome Measures :
  1. Diabetes Distress [ Time Frame: 6 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03158415


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
University of South Florida
Investigators
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Principal Investigator: Anastasia Albanese-O'Neill, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03158415     History of Changes
Other Study ID Numbers: IRB201700810
13177 ( Other Identifier: University of Florida )
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
mHealth
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases