Taiwanese Digital Foot Self-Management Program for Older-Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Foot Care Self-Efficacy Scale
研究概览
简要总结
The aims of this proposed study are to evaluate the effect of a digital foot self-management program on the primary outcome of self-efficacy, and secondary outcomes of self-care behaviors, HbA1c and health promotion satisfaction for older adults with type 2 diabetes.
详细描述
Literature reveals the needs for diabetic foot self-management intervention programs associated with positive changes in behavior. However, lack of studies focused on measure or improve health outcomes. Promoting effective diabetic foot care strategies in community is more critical than ever during a pandemic such as COVID.
This study are to evaluate the effect of a digital foot self-management program on self-efficacy, self-care behaviors, HbA1c and health promotion satisfaction for older adults with type 2 diabetes.
The contents of the 4-week program include: using a digital platform to providing foot self-management (checking conditions of foot, cleaning, cutting or removing corns and calluses, trimming, clipping nails, foot exercise, dietary related to foot care, foot care logs, etc). A developed digital platform as a self-help foot self-management education resource. The program specifically developed for older adults with diabetes to assist and management their own feet at homes. Week 1 face-to-face training session. Week 2 to week 4 following phone call once per week and LINE messages 3 times per week.by research nurse to encourage and monitor participant's compliance with the program at home by using the digital platform.
A total of 100 older adults with type 2 diabetes will be recruited from the 5 community clinics in southern Taiwan.A computerised random number generated by an independent statistician will be used to allocate each potential participant to the control or intervention group in a one-to-one ratio. All participants will be blinded to group allocation. Participants in control group will receive routine care provided in diabetes clinic, including routine check-ups and foot care education. While participants in the intervention group received the digital foot self-management program in addition to the routine care. Data will be collected at baseline and 4 weeks from baseline for self-efficacy, self-care behaviors,health promotion satisfaction and 12 weeks from baseline for HbA1c. The digital program will be delivered by trained registered nurse. A research assistant will be blinded to study protocol, who are employed to undertake data collection.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with type 2 diabetes.
- •≧65 years.
- •Possess and able to use a smart device (e.g. Samsung Galaxy, iPhone, iPad, tabletop)
- •Are able to speak and comprehend Chinese
排除标准
- •Unable to perform physical activities.
- •Cognitive impairments.
- •Unable to read and speak Chinese
结局指标
主要结局
Foot Care Self-Efficacy Scale
时间窗: 4-week
Foot care self-efficacy was assessed using the Foot Care Self Efficacy Scale consisted of 16 items to measure individual's competence to manage foot care. Cronbach's alpha was .72. There are 16 items on the self-made scale in this study. Scored using a five-point Likert scale: "completely disagree", "slightly disagree", "no opinion", "slightly agree" and "completely agree", with a maximum score of 80 and a minimum of 16; represented higher values indicate higher foot care self-efficacy (Chen, 2005). The reliability Cronbach's alpha values were 0.82 in this study. The scale was used at baseline and week 4 for participants in both control and experimental groups.
次要结局
- Health promotion satisfaction(4-week)
- HbA1c level(12-week)
- Diabetic Foot Self-Care Behavior Scale(4-week)
研究者
Shu-Ming Chen
Associate Professor
Fooyin University