Type1diabetesNCT03158415
Parents of Young Adults With Type 1 Diabetes: An Exploratory Study
A study testing T1DToolkit.org mobile diabetes education in people with Type1diabetes and Parents, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes, Parents
- What is being tested?
- T1DToolkit.org mobile diabetes education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 18 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Type1diabetes, Parents
- Being tested
- T1DToolkit.org mobile diabetes education
- Keywords
- mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1DToolkit.org mobile diabetes educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: T1DToolkit.org mobile diabetes education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 May 2017
- Primary completion18 Jul 2017
- Study completion18 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed Methods Exploratory Study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida
- Responsible party
- Sponsor
- Investigators
- Anastasia Albanese-O'Neill, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158415
- Sponsor's protocol ID
- IRB201700810
- Other IDs
- 13177
- Status last verified
- Feb 2019
- First submitted
- 16 May 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents of Young Adults With Type 1 Diabetes: An Exploratory Study
- ClinicalTrials.gov ID
- NCT03158415
- Acronym / sponsor ID
- IRB201700810
- Conditions
- Type1diabetes, Parents
- Keywords
- mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of South Florida
- Study start
- 1 May 2017 (actual)
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 18 Jul 2017 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed Methods Exploratory Study
| Arm | Type | Receives |
|---|---|---|
| Parents of Young Adults with T1D | Experimental | Behavioral: T1DToolkit.org mobile diabetes educationParents 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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (2 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T1DToolkit.org mobile diabetes educationParticipants 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. | Behavioural | Parents of Young Adults with T1D |
Primary outcome
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.
1 secondary outcome
Diabetes Distress
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasia Albanese-O'Neill, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T1DToolkit.org mobile diabetes education in people with Type1diabetes and Parents, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lived experience (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.