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Diabetes Mellitus, Type 1T1DoingWellNCT02877680

Strengths-Based Behavioral mHealth App for Parents of Adolescents With Type 1 Diabetes-Pilot Study

A study testing T1Doing Well in people with Diabetes Mellitus, Type 1, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Type 1 diabetes (T1D) management is particularly challenging during adolescence as responsibility for management begins to shift from parents to youth, and positive family teamwork is critical to achieving optimal diabetes outcomes. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
T1Doing Well
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
31 Jul 2017to 30 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of type 1 diabetes according to American Diabetes Association criteria for at least 6 months
  • Treated for type 1 diabetes at Texas Children's Hospital Diabetes Care Center
  • Parent and adolescent fluency in English
  • Parent has mobile device with data plan

Who cannot join

  • Serious medical, cognitive, or mental health comorbidity in parent or adolescent that would preclude ability to participate

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Children's Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Development and Pilot of a Strengths-Based Behavioral mHealth Intervention to Promote Resilience in Adolescents With Type 1 Diabetes

Type 1 diabetes (T1D) management is particularly challenging during adolescence as responsibility for management begins to shift from parents to youth, and positive family teamwork is critical to achieving optimal diabetes outcomes. Existing behavioral family interventions for T1D are beneficial but have limited potential for translation to clinical practice, and universal preventive approaches designed to explicitly promote existing T1D management strengths are needed. Ultimately, the goal of this line of research is to validate brief, convenient, and helpful tools that families of all adolescents with T1D can use to strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.

Read the detailed description

Type 1 diabetes (T1D) is among the most common chronic conditions of childhood and its management is complex and relentless. Adolescents have increased risk for worsening glycemic control, putting them at risk for short- and long-term complications. As responsibility for daily T1D management tasks begins to shift from parents to youth, supportive parent-adolescent teamwork promotes optimal diabetes outcomes. However, adolescents' cognitive development, desire for autonomy, and changing family and social relationships can make adherence to treatment recommendations difficult and strain attempts at parent-adolescent teamwork. This study aims to develop and pilot test a mobile app-based behavioral intervention to facilitate positive, supportive parent-adolescent interactions around T1D management. The proposed study has two parts. First, adolescents with T1D (age 12-17), their parents, and diabetes care providers will be invited to participate in designing a smartphone app that supports parents to recognize, keep track of, and reinforce their adolescents for specific positive T1D-related behaviors, or strengths. Example strengths include asking for help with complicated diabetes tasks, talking to friends about diabetes, and expressing confidence or optimism about T1D management. Intermittently throughout the day, the app will push parents a prompt to report which positive T1D behaviors their adolescent has engaged in. The app will generate weekly summary reports of each adolescent's most frequent strength behaviors, and parents will be reminded via the app to praise their adolescent for those patterns. Second, this intervention will be pilot tested with 82 families; parents will be randomized to an intervention or a control condition. Participants in the intervention condition will use the app for 3-4 months and provide feedback, and control participants will receive usual care and will not use the app. The main goal is to determine how often and in what ways families use the app, whether they like it, and to obtain suggestions for improvement. Trends for impact on important diabetes outcomes, such as quality of parent-adolescent relationships, T1D treatment adherence, and glycemic control will also be evaluated. Data - including questionnaires, adherence data from blood glucose meters, and glycemic control biomarkers from a blood draw - will be collected at baseline and again 3-4 months later. The results of this pilot study will help refine the intervention so that it can be evaluated in a fullscale randomized controlled trial. Ultimately, the goal of this research is to validate brief, convenient, and helpful tools that families of all adolescents with T1D can use to strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.

Being tested
T1Doing Well
Keywords
Strengths-based, Mobile Health (mHealth), Adolescence, Resilience, Family
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T1Doing WellBehavioural

    Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors

Study groups in NCT02877680
Study groupRoleWhat they receive
InterventionExperimentalSmartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.
Receives: Behavioral: T1Doing Well
Usual CareNo interventionUsual diabetes care and study-related data collection, without use of app during the study period. They will be offered an opportunity to try the app and share their feedback with the study team after completing follow-up data collection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Study Design - Recruitment Rate

    Recruitment data measured by percent of recruited families that enrolled in study.

    Measured: Immediately following enrollment (baseline timepoint)

  2. Feasibility of T1Doing Well App - Engagement With App At Least Twice A Week

    Feasibility of the app measured by percentage of participants that engaged with or used the app at least twice a week during the intervention period.

    Measured: 3-4 months after enrollment (follow-up timepoint)

  3. Acceptability of T1Doing Well App (Survey)

    Participants in the intervention arm completed the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE), a measure of the users' perceived usefulness of, satisfaction with, and ease of use of a particular technology. The item scale ranges from the minimum to maximum possible score is 1-7, with a higher score representing a better outcome. Acceptability measured as percentage of participants who selected a score of at least 4 (out of 7) on the item "I am satisfied with it," indicating it was at least somewhat acceptable.

    Measured: 3-4 months after baseline (follow-up timepoint)

  4. Acceptability - Number of Participants That Felt The Intervention Was Well-Received

    The number of participants that felt the intervention was well-received was collected for Adolescents and Parents. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral. Positive responses indicate the intervention was well-received.

    Measured: 3-4 months after baseline (follow-up timepoint)

Secondary outcomes (15)
  1. Adherence to Diabetes Regimen (Objective) - Blood Glucose Monitoring Frequency

    Objective measurement of adherence to diabetes regimen measured by blood glucose monitoring frequency (a well-accepted surrogate of overall adherence), obtained via blood glucose meter downloads. The average daily frequency was calculated over the 14 days prior to the assessment at the baseline visit.

    Measured: 3-4 months after baseline (follow-up timepoint)

  2. Glycemic Control - HbA1c

    At the time of this study, the American Diabetes Association generally recommended an HbA1c target of <7.0% (it was <7.5% at the time this study took place, for individuals younger than 18 years. The especific target varies depending on the individual). The DCA 2000 HbA1c Analyzer (Siemens-Bayer) was used for point of care HbA1c analysis, it has an analytical measurement range for HbA1c of 2.5% to 14.0%. HbA1c values are collected via fingerstick and blood assay at routine diabetes care visits and values were extracted from the medical record at each clinic visit during the study period.

    Measured: 3-4 months after baseline (follow-up timepoint)

  3. Diabetes Family Impact - Diabetes Family Impact Scale (DFIS), Parent-report

    Diabetes-specific family impact was measured using the Diabetes Family Impact Scale (DFIS), a 15-item measure of the impact of diabetes on family members' activities and relationships. The scale range from the minimum to maximum possible score is 0-100. A higher score represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  4. Family Impact - Pediatric Quality of Life Impact Module (Peds QL-FI), Parent-report

    Family impact was measured using The Pediatric Quality of Life Family Impact Module (Peds QL-FI), a 36-item measure of the impact of parenting a child with a chronic medical condition on family functioning and parent QOL. The scale range from the minimum to the maximum score is 0-100. A higher score represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  5. Family Communication - Helping for Health Inventory (HHI), Parent-report

    Family communication was measured by the parent-report Helping for Health Inventory (HHI), a 15-item questionnaire assessing perceptions of parental help around the teen's diabetes management. The scale range from the minimum to maximum possible score is 15-75. A lower score represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  6. Family Communication - Helping for Health Inventory (HHI), Adolescent-report

    Family communication was measured using the adolescent-report Helping for Health Inventory (HHI), a 15-item questionnaire assessing perceptions of parental help around the teen's diabetes management. The scale range from the minimum to maximum possible score is 15-75. A lower score represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  7. Diabetes Family Conflict Scale-Revised (DFCS), Parent-report

    Family conflict was measured using the Diabetes Family Conflict Scale - Revised (DFCS), a measure of diabetes-specific conflict in families with adolescents with type 1 diabetes. The scale range from the minimum to maximum possible score is 19-57. A lower score represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  8. Diabetes Family Conflict Scale-Revised (DFCS), Adolescent-report

    Family conflict was measured using the Diabetes Family Conflict Scale - Revised (DFCS), a measure of diabetes-specific conflict in families with adolescents with type 1 diabetes. The scale range from the minimum to maximum possible score is 19-57. A lower score represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  9. Problem Areas in Diabetes-Teen (PAID-T), Parent-report

    Diabetes burden was measured using the Problem Areas in Diabetes (PAID-T) parent-report, a measure of how bothersome day-to-day problems are for parents of adolescents with type 1 diabetes. The scale range from the minimum to maximum possible score is 26-156. A lower score represents better a outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  10. Problem Areas in Diabetes-Teen (PAID-T), Adolescent Self-report

    Diabetes burden was measured using the Problem Areas in Diabetes-Teen (PAID-T) self-report, a measure of how bothersome day-to-day problems are for adolescents with type 1 diabetes. The scale range from the minimum to maximum possible score is 26-156. A lower score represents better a outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  11. Self-Management - Diabetes Self-Management Profile (DSMP), Parent-report

    Parent-report of adolescent self-management was measured using the 24-item Diabetes Self-Management Profile Self-Report (DSMP). Parents completed the version appropriate to their child's current diabetes regimen (conventional insulin regimen, 24 items; flexible insulin regimen, 24 items). The scale range from the minimum to maximum possible score is 0-86. A higher score represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  12. Self-Management - Diabetes Self-Management Profile (DSMP), Adolescent Self-report

    Self-management was measured using the Self-Care Inventory-Revised (SCI-R), a 15-item measure of the frequency that adolescents engage in diabetes management behaviors on a 5-point scale from Never to Always. The scale range from the minimum to maximum possible score is 5-75. A higher score represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  13. Diabetes Strengths and Resilience Measure (DSTAR), Adolescent Self-report

    The Diabetes Strengths and Resilience measure is a self-report assessment of positive behaviors related to diabetes resilience for youth with type 1 diabetes, such as perceived competence to manage the demanding diabetes regimen, to adapt to the unpredictability of diabetes, and to seek help and support with diabetes challenges. The scale range from the minimum to maximum possible score is 0-48. A higher value on this scale represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  14. Adolescent Quality of Life - The MIND-Youth Questionnaire, Adolescent Self-report

    Adolescent quality of life was measured using the Monitoring Individual Needs in Diabetes Youth Questionnaire (MIND-Youth/MY-Q), a 33-item measure of diabetes-specific health-related QOL. The scale range from the minimum to maximum possible score is 0-100. A higher score represents a better outcome.

    Measured: 3-4 months after baseline (follow-up timepoint)

  15. Parent-Adolescent Relationship Intervention Process Measure, Adolescent Report

    Adolescents answered 3 items adapted from the Parent-Youth Relationship Index of the National Longitudinal Study of Youth-1997, a measure of parent-adolescent relationship quality. Item scale ranges from minimum to maximum score of 1-5 for each item, with a higher score indicating a better outcome.

    Intervention process from baseline to follow-up was analyzed using a general linear mixed model, using the item "How often does he/she praise you for doing well?" Time since first baseline clinic visit was computed and analyzed using a mixed model with time, arm, and the time-arm interaction term. The outcome measure data are reported as slopes by arm.

    *NOTE: Intervention process measures were administered biweekly, and we are reporting the calculated mean change per day with 95% confidence intervals.

    Measured: 3-4 months after baseline (follow-up timepoint)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2016 (estimated)
  2. Study start31 Jul 2017
  3. Primary completion30 May 2019
  4. Study completion30 May 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02877680
Sponsor's protocol ID
H-37311
Other IDs
1R21DK107951
Acronym
T1DoingWell
Status last verified
Sep 2020
First submitted
17 Aug 2016
Last updated
24 Sep 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual health data will be collected that is not already available to families through their electronic medical record

Publications

  • Hilliard ME, Cao VT, Eshtehardi SS, Minard CG, Saber R, Thompson D, Karaviti LP, Anderson BJ. Type 1 Doing Well: Pilot Feasibility and Acceptability Study of a Strengths-Based mHealth App for Parents of Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Nov;22(11):835-845. doi: 10.1089/dia.2020.0048. Epub 2020 May 22.

    PubMed 32379496
  • Hilliard ME, Eshtehardi SS, Minard CG, Saber R, Thompson D, Karaviti LP, Rojas Y, Anderson BJ. Strengths-Based Behavioral Intervention for Parents of Adolescents With Type 1 Diabetes Using an mHealth App (Type 1 Doing Well): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2018 Mar 13;7(3):e77. doi: 10.2196/resprot.9147.

    PubMed 29535081

Questions about this trial

What is this clinical trial studying?

A study testing T1Doing Well in people with Diabetes Mellitus, Type 1, run by Baylor College of Medicine 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 4 inclusion and 1 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 24 Sep 2020. 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?

Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of Study Design - Recruitment Rate (time frame: Immediately following enrollment (baseline timepoint)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02877680, which also lists 2 linked publications.

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 24 Sep 2020.

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