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Using an mHealth App to Transition Care of Type 1 Diabetes from Parents to Teens: Protocol for a Pilot Study.

ABSTRACT: BACKGROUND:Type 1 diabetes mellitus (T1DM) afflicts approximately 154,000 people under the age of 20 in the United States. Most people with T1DM are diagnosed at a young age, and parents have to take on the responsibility of T1DM management. Eventually, the child must begin to transition to self-management. Adolescents often struggle to take on responsibility for all the necessary tasks to successfully self-manage their T1DM. In fact, approximately three-quarters of adolescents are not achieving American Diabetes Association-recommended glycated hemoglobin (HbA1c) targets. This lack of adherence can lead to negative health outcomes. OBJECTIVE:The goals of this interdisciplinary proposal are as follows: (1) to develop a unique and theory-driven technology using a mobile phone app to promote self-management behaviors for adolescents aged 10-15 years with T1DM and their parents and (2) to explore the feasibility and impact of the self-management mobile app. METHODS:This study has two phases: app development and pilot testing. In the app development phase, the app will be conceptualized and a prototype will be tested. In Phase 2, the mobile app will undergo pilot testing to determine its feasibility and impact on diabetes self-management. RESULTS:The pilot test was launched in September 2017. Data collection for the final pilot test is underway, and results are forthcoming. CONCLUSIONS:Adolescents with T1DM and their parents can have a difficult time managing the transition of diabetes care. It is hoped that this app can help. The focus groups and prototype testing have indicated promising outcomes of app use. TRIAL REGISTRATION:ClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628 (Archived by WebCite at http://www.webcitation.org/72tHXTE2Z). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/10803.

SUBMITTER: Holtz BE

PROVIDER: S-EPMC6234347 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Using an mHealth App to Transition Care of Type 1 Diabetes from Parents to Teens: Protocol for a Pilot Study.

Holtz Bree E BE Mitchell Katharine M KM Hershey Denise D DD Cotten Shelia R SR Holmstrom Amanda J AJ Richman Joshua J Dunneback Julie K JK Wood Michael A MA

JMIR research protocols 20181030 10

<h4>Background</h4>Type 1 diabetes mellitus (T1DM) afflicts approximately 154,000 people under the age of 20 in the United States. Most people with T1DM are diagnosed at a young age, and parents have to take on the responsibility of T1DM management. Eventually, the child must begin to transition to self-management. Adolescents often struggle to take on responsibility for all the necessary tasks to successfully self-manage their T1DM. In fact, approximately three-quarters of adolescents are not a ...[more]

PMID: 30377142

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Project description:BACKGROUND:Supportive parent involvement for adolescents' type 1 diabetes (T1D) self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. OBJECTIVE:The aim of this protocol was to describe the development of a new, strengths-based behavioral intervention for parents of adolescents with T1D delivered via a mobile-friendly Web app called Type 1 Doing Well. METHODS:Ten adolescent-parent dyads and 5 diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3- to 4-month pilot intervention will involve 82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (ie, positive attitudes or behaviors related to living with or managing T1D) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen's most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages (short message service, SMS). RESULTS:The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. CONCLUSIONS:This strengths-based, mobile health (mHealth) intervention aims to help parents increase their awareness of and efforts to support their adolescents' engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative family teamwork, and ultimately improve diabetes outcomes. TRIAL REGISTRATION:ClinicalTrials.gov NCT02877680; https://clinicaltrials.gov/ct2/show/NCT02877680 (Archived by WebCite at http://www.webcitation.org/6xTAMN5k2).

Project description:BackgroundType 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, MyT1DHero, was designed to facilitate diabetes-specific positive parent-adolescent communication and improve diabetes-related outcomes. The MyT1DHero intervention links an adolescent with T1D and their parent through 2 separate app interfaces and is designed to promote positive communication regarding T1D management.ObjectiveThe aim of this pilot study was to determine (1) the initial efficacy of the MyT1DHero intervention in improving diabetes outcomes in adolescents, specifically the hemoglobin A1c (HbA1c) levels, diabetes care adherence, and quality of life, and (2) the adolescents' overall satisfaction with this intervention.MethodsThis pilot study included 30 adolescent-parent pairs who used the MyT1DHero app in a 12-week single-arm clinical trial. Participants were recruited from the local pediatric endocrinology subspecialty clinic via snowball sampling. HbA1c levels, diabetes care adherence, quality of life, family conflict, and satisfaction levels were measured and analyzed using paired sample two-sided t tests and linear regression analyses.ResultsThe 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]; t21=-2.52, P=.02, d=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]; t24=2.48, P=.01, d=0.32). HbA1c levels (before the study: mean 8.94 [SD 1.46]; after the study: mean 8.87 [SD 1.29]; t24=0.67, P=.51, d=0.04) and family conflict (before the study: mean 2.45 [SD 0.55]; after the study: mean 2.61 [SD 0.45]; t23=0.55, P=.14, d=0.32) changed in the hypothesized direction, but the change was not significant. However, higher use of the mobile app was associated with more improvement in HbA1c levels (F1,20=9.74, P<.005; R2=0.33). Overall, the adolescents were satisfied with the app intervention.ConclusionsIn 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.Trial registrationClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628.

Project description:BackgroundDiabetic foot ulcers (DFUs) cause significant morbidity affecting 19% to 34% of people living with diabetes mellitus. DFUs not only impair quality of life but may also result in limb loss and mortality. Patient education has been advocated to raise awareness of proper foot self-care and the necessity of seeking assistance when a foot wound occurs. Modern technologies, including mobile health (mHealth) interventions such as health apps, bring the potential for more cost-effective and scalable interventions.ObjectiveThis study aims to examine the feasibility and usability of a newly developed mHealth app called Well Feet, which is a diabetes and foot care education app for individuals at risk of developing DFU.MethodsWell Feet was developed using an evidence-based and expert panel cocreation approach to deliver educational content available in 3 languages (ie, English, Chinese, and Malay) via animation videos and a range of additional features, including adaptive learning. A nonrandomized, single-arm feasibility study using a mixed methods approach with a series of validated questionnaires and focus group discussions will be conducted. In total, 40 patients and carers will be recruited from a tertiary hospital diabetes clinic to receive a 1-month mHealth intervention. The primary outcomes are the usability of the app and a qualitative perspective on user experience. Secondary outcomes include changes in foot care knowledge, self-management behaviors, and quality of life.ResultsPatient recruitment began in July 2023, and the intervention and data collection will be completed by the end of September 2023. This study has been approved by National Healthcare Group Domain Specific Review Board (2022/00614) on February 10, 2023. The expected results will be published in spring 2024.ConclusionsThrough this feasibility study, the Well Feet DFU education app will undergo a comprehensive quantitative and qualitative evaluation of its usability and acceptance for future improvement in its design. With local contextualization, cultural adaptation, and its multilingual functionality, the app addresses a critical aspect of DFU health education and self-management in a multiethnic population. Findings from this study will refine and enhance the features of the app based on user feedback and shape the procedural framework for a subsequent randomized controlled trial to assess the effectiveness of Well Feet.Trial registrationClinicalTrials.gov NCT05564728; https://clinicaltrials.gov/study/NCT05564728.International registered report identifier (irrid)DERR1-10.2196/52036.

Project description:IntroductionDepression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.Methods and analysisIn a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.Ethics and disseminationThe Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.Trial registration numberNCT03490253; pre-results.

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Using an mHealth App to Transition Care of Type 1 Diabetes from Parents to Teens: Protocol for a Pilot Study.

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Using an mHealth App to Transition Care of Type 1 Diabetes from Parents to Teens: Protocol for a Pilot Study.

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