- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03158415
Parents of Young Adults With Type 1 Diabetes: An Exploratory Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32611
- University of Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anastasia Albanese-O'Neill, PhD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201700810
- 13177 (Other Identifier: University of Florida)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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