Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes (T1DM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: educational intervention via mobile app.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (Juvenile Onset), Type 1 Diabetes, Type 1 Diabetes Mellitus, HbA1c. Basic parameters: 10 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes A Pilot RCT
Overview
This study aims to evaluate the effectiveness of a mobile health (mHealth) educational intervention for adolescents with Type 1 Diabetes Mellitus (T1DM). Adolescents often face challenges in maintaining optimal blood glucose control and performing regular self-care. In this study, participants will receive structured diabetes education through a mobile application designed to improve their knowledge, self-efficacy (SE), and self-management skills. The impact of the intervention will be assessed by measuring changes in HbA1c levels, diabetes self-efficacy, and self-care (SC)behaviors over time. These findings may help determine whether mobile app-based education can support better diabetes management among adolescents.
Detailed description
Type 1 diabetes mellitus (T1DM) is a chronic illness that affects children and adolescents worldwide. It affects approximately 1.52 million individuals under the age of 20 years worldwide. The incidence increased from 7.78 per 100,000 population to 11.07 per 100,000 population from 1990 to 2019. In Pakistan, 7,927 individuals aged 20 years or younger have been diagnosed with T1DM however, this number is most likely underreported.
T1DM is a challenging illness to manage because it requires adherence to strict self-management regimes involving frequent glucose monitoring, insulin administration, balancing physical activity, diet control, and the prevention and management of acute complications. Its management becomes more challenging in adolescents (10-19 years), which is a transitional period from childhood to adulthood. During this phase, significant hormonal and physiological changes occur, which can increase insulin resistance and thus deteriorate glucose metabolism. Furthermore, individuals in their adolescence strive for independence but also tend to socialize more with their agemates, which transforms their eating habits and physical activity patterns. This makes it difficult for adolescents to embrace the responsibility of managing their diabetes. The literature suggests that adolescents with diabetes lack sufficient knowledge and skills to effectively manage their illness. These challenges can result in inadequate glycemic control, as evidenced by higher glycated hemoglobin (HbA1c) levels in adolescents than in children and adults with T1DM. The World Health Organization emphasizes the role of self-efficacy and self-care behaviors in adolescents to improve glycemic control and prevent diabetes-related complications. A recent study in Capital Territory of Pakistan reported that 49.2% of the adolescents with T1DM have inadequate self-care. This study also reported a negative correlation between self-care and HbA1c levels. These findings suggest that self-care practices are the key to achieving better glycemic control.
The literature indicates that structured educational interventions (SEI) can significantly improve healthy lifestyle practices among adolescents with T1DM and enhance their self-efficacy. Diabetes-related education has been shown to reduce the frequency of hypoglycemic episodes and improve glycemic control. Structural intervention programs are the recommended approach for the optimal maintenance of self-care behaviors.
Compared with the conventional approach to education, the use of smartphones by adolescents offers an excellent medium for improving health literacy regarding various health problems, including diabetes. Various mobile health applications (apps) have been developed and are being used to improve health literacy and promote self-management practices in patients with diabetes in various age groups, including adolescents. Some experimental studies have also demonstrated the effectiveness of SEI delivered via mobile health apps in improving self-efficacy and modestly reducing HbA1c in adolescents with T1DM.
Problem Statement Limited interventional research has been conducted on adolescents with T1DM in Pakistan, with the exception of one study. Existing research has primarily focused on the assessment of knowledge, complications, and self-care behaviors. Using a longitudinal design, which evaluated the effectiveness of diabetes care for T1DM patients across various age groups (0 to \> 19 years). Patients and their parents provided information on various aspects of T1DM through community-based camps. However, the details of the intervention regarding the duration and mode of delivery have not been reported. Furthermore, this approach may be inappropriate for adolescents. A qualitative study of adolescents with T1DM in Pakistan highlighted several significant challenges regarding the inability of adolescents to independently manage their disease, including complications, psychological stress, and social stigmatization associated with the disease. The participants in this study reported a lack of comprehensive training and formal education in diabetes management. Moreover, Insufficient support from healthcare professionals leads to reliance on informal information sources .
Concomitant with the above findings, I observed my 14-year-old daughter with T1DM relying heavily on Internet sources to seek information regarding her condition. Although a wealth of information is available online, it is crucial to find authentic, age-appropriate, and culture-specific content for adolescents. Globally, several apps are available for the education of adolescents with T1DM. However, existing international apps may not be suitable for the Pakistani context. Details about the international app are provided in Appendix A. The locally available apps are not comprehensive, as they focus on a single aspect of self-care, such as glucose tracking or diet. Moreover, the existing apps only serve as a source of information, but they do not provide an opportunity for the active involvement of adolescents in managing their disease. Given the increasing prevalence, uncontrolled glycemic levels, inadequate self-care in T1DM and unavailability of the age-appropriate apps, it is imperative to design and test a comprehensive structured educational intervention that is feasible and engaging in teaching adolescents about self-care. The literature suggests that adolescents learn more efficiently through mobile apps. Hence, the structured educational intervention will be delivered through a mobile app to improve HbA1c levels, self-efficacy, and self-care practices.
Purpose of the study This study will assess the feasibility of a pilot RCT and evaluate the effectiveness of a structured educational intervention delivered through a mobile app on HbA1c levels, self-efficacy, and self-care among adolescents with T1DM.
Interventions
- Behavioral educational intervention via mobile app
The duration of this intervention will be 12 weeks.The SEI will comprised of knowledge and skills related to self care in T1DM. Topics of knowledge will include descriptions of T1DM, insulin, diet management, physical activity, diabetes-related complications, sick day management, skin care, including foot care, and mental and social health issues. Moreover, the participants will be taught skills for monitoring blood glucose, insulin administration, and weight measurement.
Primary outcome measures
- HBA1C [Time frame: Baseline and 12 weeks]
Secondary outcome measures (2)
- Self Efficacy [Time frame: Baseline and 12 weeks]
- Self Care [Time frame: Baseline and 12 weeks]
Eligibility criteria
Inclusion criteria
Adolescents aged 10 to 19 years. Diagnosed with Type 1 Diabetes Mellitus (T1DM) by a physician for at least 6 months.
HbA1c greater than or equal to 7%. Have access to a smartphone or tablet (owned by the participant or parent/guardian).
Exclusion criteria
Use of an insulin pump. Current use of any smartphone application for diabetes self-management. Presence of comorbid conditions that may interfere with participation in the study.
Diagnosis of intellectual disability or other cognitive impairment documented in the medical record that may limit the participant's ability to complete questionnaires or comply with intervention requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Abraham, M. B., Jones, T. W., Naranjo, D., Karges, B., Oduwole, A., Tauschmann, M., & Maahs, D. M. (2018). ISPAD Clinical Practice Consensus Guidelines 2018: Assessment and management of hypoglycemia in children and adolescents with diabetes. Pediatric diabetes, 19. Adolescent Health. (2023, Jan, 20). https://www.who.int/health-topics/adolescent-health#tab=tab_1 Adolfsson, P., Taplin, C. E., Zahar
Identifiers
NCT: NCT07689318 · STMU-T1DM-mHealth-2025-01