An mHealth-Based Intervention for Adolescents With Type 1 Diabetes and Their Parents: Pilot Feasibility and Efficacy Single-Arm Study (Preprint)

Abstract

Type 1 diabetes (T1D) affects more than 165,000 individuals younger than 20 years in the United States of America. The transition from parent management to parent-child team management, with the child taking on increased levels of self-care, can be stressful and is associated with a deterioration in self-management behaviors. Therefore, a mobile app intervention, <i>MyT1DHero,</i> was designed to facilitate diabetes-specific positive parent-adolescent communication and improve diabetes-related outcomes. The <i>MyT1DHero</i> intervention links an adolescent with T1D and their parent through 2 separate app interfaces and is designed to promote positive communication regarding T1D management.

The aim of this pilot study was to determine (1) the initial efficacy of the <i>MyT1DHero</i> intervention in improving diabetes outcomes in adolescents, specifically the hemoglobin A_1c (HbA_1c) levels, diabetes care adherence, and quality of life, and (2) the adolescents’ overall satisfaction with this intervention.

This pilot study included 30 adolescent-parent pairs who used the <i>MyT1DHero</i> app in a 12-week single-arm clinical trial. Participants were recruited from the local pediatric endocrinology subspecialty clinic via snowball sampling. HbA_1c levels, diabetes care adherence, quality of life, family conflict, and satisfaction levels were measured and analyzed using paired sample two-sided <i>t</i> tests and linear regression analyses.

The final analysis included 25 families. The mean age of the adolescents was 12.28 (SD 1.62) years. Half of the participants (13/25) reported a diabetes diagnosis of less than 5 years. After 12 weeks of the intervention, diabetes care adherence significantly improved (before the study: mean 3.87 [SD 0.59]; after the study: mean 4.19 [SD 0.65]; <i>t</i>₂₁=–2.52, <i>P</i>=.02, <i>d</i>=0.52) as did quality of life (before the study: mean 4.02 [SD 0.84]; after the study: mean 4.27 [SD 0.73]; <i>t</i>₂₄=2.48, <i>P</i>=.01, <i>d=</i>0<i>.</i>32). HbA_1c levels (before the study: mean 8.94 [SD 1.46]; after the study: mean 8.87 [SD 1.29]; <i>t</i>₂₄=0.67, <i>P</i>=.51<i>, d=0.</i>04) and family conflict (before the study: mean 2.45 [SD 0.55]; after the study: mean 2.61 [SD 0.45]; <i>t</i>₂₃=0.55, <i>P</i>=.14, <i>d</i>=0<i>.</i>32) changed in the hypothesized direction, but the change was not significant. However, higher use of the mobile app was associated with more improvement in HbA_1c levels (<i>F</i>_1,20=9.74, <i>P</i>&lt;.005; R²=0.33). Overall, the adolescents were satisfied with the app intervention.

In a 12-week pilot study of the mobile app intervention designed to facilitate parent-adolescent communication for improving diabetes outcomes, significant benefits were demonstrated in self-care adherence and quality of life. A randomized controlled trial with a longer intervention is needed to replicate these findings and to determine the stability of the intervention effects.

ClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628