NCT03158415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2017

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

May 16, 2017

Last Update Submit

February 25, 2019

Conditions

Keywords

mHealth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Diabetes Distress

    6 weeks

Study Arms (1)

Parents of Young Adults with T1D

EXPERIMENTAL

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

Interventions

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.

Parents of Young Adults with T1D

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

  • Anastasia Albanese-O'Neill, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Mixed Methods Exploratory Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 18, 2017

Study Start

May 1, 2017

Primary Completion

July 18, 2017

Study Completion

July 18, 2017

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations