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Strengths-Based Behavioral mHealth App for Parents of Adolescents With Type 1 Diabetes-Pilot Study (T1DoingWell)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02877680
Recruitment Status : Active, not recruiting
First Posted : August 24, 2016
Last Update Posted : January 16, 2019
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Feinberg School of Medicine, Northwestern University
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Marisa Hilliard, Baylor College of Medicine

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Behavioral: T1Doing Well Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Pilot of a Strengths-Based Behavioral mHealth Intervention to Promote Resilience in Adolescents With Type 1 Diabetes
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Intervention
Smartphone 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.
Behavioral: T1Doing Well
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

No Intervention: Usual Care
Usual 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.

Primary Outcome Measures :
  1. Feasibility of Study Design [ Time Frame: 3-4 months after baseline ]
    Recruitment data will be used to calculate the percent of eligible families who enroll in the study. Usage data from the software platform will be used to calculate parent engagement with specific app features (e.g., response rate to prompts, frequency of opening feedback summaries, frequency of giving adolescent positive feedback) and the percent of participants who interact with any app feature at least twice weekly.

  2. Acceptability (survey) [ Time Frame: 3-4 months after baseline ]
    Post-intervention, participants will complete a validated measure of the users' perceived usefulness of, satisfaction with, and ease of use of a particular technology.

  3. Acceptability (interview) [ Time Frame: 3-4 months after baseline ]
    Semi-structured interviews with parents and adolescents will be conducted to contextualize survey responses, discuss experiences with the app (e.g., intrusiveness of prompts, clarity/relevance of response options, usefulness and appeal of strength behavior feedback charts), and obtain suggestions for improvement.

Secondary Outcome Measures :
  1. Glycemic control [ Time Frame: 3-4 months after baseline ]
    Glycemic control (HbA1c) and blood glucose monitoring frequency are collected routinely at diabetes visits and will be extracted from the electronic medical record. Trained phlebotomists draw blood samples by fingerstick and analyze assays immediately using the DCA 2000 Hemoglobin HbA1c system (Siemens-Bayer).

  2. Adherence (objective) [ Time Frame: 3-4 months after baseline ]
    Glucometers are routinely downloaded and mean daily blood glucose monitoring frequency (previous 14 days) will be calculated.

  3. Adherence (self-report) [ Time Frame: 3-4 months after baseline ]
    Adolescents and parents will also each rate youth adherence to the diabetes regimen using the appropriate version (based on youth's insulin regimen) of the 24-item Diabetes Self-Management Profile Self-Report (DSMP-SR).

  4. Diabetes strengths [ Time Frame: 3-4 months after baseline ]
    Adolescents will self-report on the frequency of resilience-promoting attitudes and behaviors (i.e., strengths) via the Diabetes Strengths and Resilience measure (DSTAR), a 12-item measure of perceived mastery over T1D management demands and accessing social/family support for T1D needs.

  5. Diabetes-related family conflict [ Time Frame: 3-4 months after baseline ]
    Parents and youth will complete the Diabetes Family Conflict Scale Revised (DFCS-R), a 19-item scale of family conflict surrounding diabetes issues, which has good reliability and validity.

  6. Diabetes burden/distress [ Time Frame: 3-4 months after baseline ]
    Diabetes-specific burden will be assessed via the Problem Areas in Diabetes measures for adolescents (PAID-T, 26 items) and parents (PAID-PR, 18 items); both demonstrate good psychometric properties.

  7. Health-related quality of life [ Time Frame: 3-4 months after baseline ]
    Youth will complete the MIND-Youth Questionnaire (MY-Q), a 33-item measure of diabetes health-related QOL.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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 identifier (NCT number): NCT02877680

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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Feinberg School of Medicine, Northwestern University
United States Department of Agriculture (USDA)
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Principal Investigator: Marisa E Hilliard, PhD Baylor College of Medicine and Texas Children's Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marisa Hilliard, Assistant Professor of Pediatrics, Baylor College of Medicine Identifier: NCT02877680     History of Changes
Other Study ID Numbers: H-37311
1R21DK107951 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual health data will be collected that is not already available to families through their electronic medical record

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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 Marisa Hilliard, Baylor College of Medicine:
Mobile Health (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