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

Diabetes Mellitus, Type 1 Clinical Trial

— T1DoingWell  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877680
• Other study ID #: H-37311
• Secondary ID: 1R21DK107951
• Status: Completed
• Phase: N/A
• Start date: July 31, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: September 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Baylor College of Medicine	Feinberg School of Medicine, Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Study Design - Recruitment Rate	Recruitment data measured by percent of recruited families that enrolled in study.	Immediately following enrollment (baseline timepoint)
Primary	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.	3-4 months after enrollment (follow-up timepoint)
Primary	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.	3-4 months after baseline (follow-up timepoint)
Primary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)
Secondary	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.	3-4 months after baseline (follow-up timepoint)