跳至主要内容
临床试验/NCT07689318
NCT07689318尚未招募不适用

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

Shifa Tameer-e-Millat University0 个研究点目标入组 84 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
84
主要终点
HBA1C

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

HBA1C

时间窗: Baseline and 12 weeks

A reading below 7% indicates satisfactory diabetic control, whereas a reading above 7% indicates poor diabetic control

次要结局

  • Self Efficacy(Baseline and 12 weeks)
  • Self Care(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

相似试验