The Effect of Educatıonal Program and Remınder Mobıle Applıcatıons on Foot Self-Care Behavıors, Dıabetes Management Self-Effectıveness and Qualıty of Lıfe in Type 2 Dıabetes: A Randomızed Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Diabetes Foot Self-Care Behavior Score
研究概览
简要总结
Diabetes mellitus is a metabolic disease with systemic, acute and chronic complications whose prevalence is increasing all over the world and in our country (Satman et al. 2013). The prevalence of diabetes all over the world and in Turkey is increasing day by day and this situation is becoming an important public health problem (Aytemur and Vardar İnkaya 2022). Diabetic foot is an important complication that causes organ loss, affects individuals mentally, physically, socially and economically, and requires frequent hospitalization and surgical intervention (Danmusa et al. 2016, Kalaycı et al. 2020). In the prevention of diabetes, it is necessary to raise awareness and gain healthy lifestyle behaviors. This study aims to increase foot self-care behaviors, diabetes management self-efficacy and quality of life of individuals with type 2 diabetes with the education program and reminder mobile applications.
详细描述
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder associated with significant morbidity and mortality, including diabetic foot complications that may lead to infection, ulceration, and amputation. Effective foot self-care behaviors are essential to prevent these complications. However, many individuals with T2DM demonstrate insufficient knowledge and adherence to recommended self-care practices.
This randomized controlled trial was designed to evaluate the effectiveness of a structured education program combined with mobile reminder messages on foot self-care behaviors, diabetes management self-efficacy, and quality of life in individuals with T2DM.
Participants were randomly assigned to either an intervention group or a control group. The intervention group received a structured diabetes foot care education program and regular reminder messages delivered through mobile communication. The control group received standard care according to routine clinical practice.
Data were collected at baseline and during follow-up assessments. The primary outcome measure was foot self-care behavior. Secondary outcomes included diabetes management self-efficacy and quality of life. Validated measurement tools were used for all assessments.
The results of this study are expected to provide evidence regarding the effectiveness of education and mobile reminder interventions in improving self-care behaviors and preventing diabetes-related foot complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •Diagnosed with Type 2 Diabetes Mellitus
- •Able to read and understand Turkish
- •Owns a smartphone and uses WhatsApp
- •Provides written informed consent
排除标准
- •Exclusion Criteria:
- •Type 1 diabetes or gestational diabetes
- •Severe cognitive impairment or psychiatric disorder
- •Active diabetic foot ulcer requiring hospitalization
- •Participation in another structured diabetes education program within the last 6 months
研究组 & 干预措施
Education + Mobile Reminder Program
Participants receive a structured diabetes foot self-care education program combined with scheduled mobile reminder messages or app notifications to reinforce daily foot self-care behaviors and diabetes self-management. Assessments are performed at baseline and at follow-up according to the study protocol.
干预措施: Diabetes Education and Mobile Reminder Program (Behavioral)
Usual Care (Control)
Participants in the control group receive routine standard diabetes care provided in usual clinical practice. This includes regular medical follow-up visits, standard diabetes education delivered by healthcare professionals, and general advice on diabetes self-management and foot care as typically offered by the clinic. No additional structured education sessions, mobile reminder messages, or digital support interventions are provided during the study period. Outcome assessments are conducted at baseline, 3 months, and 6 months according to the study protocol.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change in Diabetes Foot Self-Care Behavior Score
时间窗: Baseline to 6 months
次要结局
未报告次要终点
研究者
Selma Sahin
Principal Investigator and PhD Candidate
Necmettin Erbakan University