Effectiveness of a Digital Discharge Planning Intervention to Improve Self-Management in Patients With Diabetes Mellitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in diabetes self-management score
研究概览
简要总结
Diabetes mellitus is a chronic disease that requires continuous self-management to prevent complications and hospital readmissions. However, discharge planning in many hospitals is often delivered verbally and lacks structured follow-up after patients return home, which may lead to poor self-management behaviors.
This study aims to evaluate the effectiveness of a digital discharge planning intervention delivered through a mobile application to improve self-management among patients with diabetes mellitus after hospital discharge. The intervention is based on the Chronic Care Model and includes educational materials, reminders, and monitoring tools related to seven dimensions of diabetes self-management.
A randomized controlled trial with a parallel-group design will be conducted among patients with diabetes mellitus. Participants in the intervention group will receive digital discharge planning through a mobile application for 90 days after discharge, while the control group will receive standard discharge planning provided by the hospital. Primary outcomes include patient self-management behavior, while secondary outcomes include glycemic control and hospital readmission within 90 days.
详细描述
Diabetes mellitus is one of the most prevalent chronic diseases worldwide and requires long-term self-management to maintain glycemic control and prevent complications. Effective discharge planning plays an important role in preparing patients to manage their condition independently after leaving the hospital. However, in many clinical settings, discharge planning is often delivered verbally and without structured follow-up, which may limit patients' ability to maintain appropriate self-management behaviors.
This study develops and evaluates a digital discharge planning model delivered through a mobile application to support patients with diabetes mellitus after hospital discharge. The intervention is theoretically grounded in the Chronic Care Model and supported by nursing theories including Orem's Self-Care Deficit Theory, Watson's Human Caring Theory, and Pender's Health Promotion Model.
The mobile application includes several features designed to support diabetes self-management based on the Diabetes Canada framework, including healthy eating, physical activity, blood glucose monitoring, medication adherence, problem solving, reducing risks, and healthy coping. The application provides educational materials, reminders, daily activity tracking, and feedback to encourage patient engagement and adherence to self-management practices.
A randomized controlled trial with a parallel-group design will be conducted to evaluate the effectiveness of the intervention. Participants will be randomly assigned to either the intervention group receiving digital discharge planning through the mobile application or the control group receiving standard discharge planning provided by the hospital. The intervention period will last for 90 days following hospital discharge. The study will assess the impact of the digital discharge planning model on self-management behaviors, glycemic control, and hospital readmission among patients with diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study uses a single-blind design in which the outcome assessor will be blinded to the group allocation. Participants and investigators will be aware of the intervention due to the nature of the digital discharge planning intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with diabetes mellitus.
- •Age 18 years or older.
- •Hospitalized patients who are preparing for discharge.
- •Able to use a smartphone and access the mobile application.
- •Willing to participate and provide informed consent.
排除标准
- •Patients with severe complications requiring intensive care.
- •Patients with cognitive impairment or severe mental illness that may interfere with participation.
- •Patients who are unable to operate a smartphone or mobile application.
- •Patients who decline to participate in the study.
研究组 & 干预措施
Standard Discharge Planning
Participants receive standard discharge planning routinely provided by the hospital.
干预措施: Standard Discharge Planning (Behavioral)
Digital Discharge Planning
Participants receive digital discharge planning through a mobile application for 90 days after hospital discharge.
干预措施: Digital Discharge Planning Application (Behavioral)
结局指标
主要结局
Change in diabetes self-management score
时间窗: Baseline to 90 days after hospital discharge
Diabetes self-management will be assessed using an adapted Indonesian version of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire consisting of 21 items across seven domains (healthy eating, physical activity, blood glucose monitoring, medication adherence, problem solving, risk reduction, and healthy coping). Each item is scored on a 5-point Likert scale (1-5) reflecting frequency of behavior during the past 7 days. Total scores range from 21 to 105, with higher scores indicating better diabetes self-management behavior.
次要结局
- Change in HbA1c level(Baseline to 90 days)
- Hospital readmission within 90 days(Within 90 days after hospital discharge)
研究者
Ririn Kartika Novitasari
Master's Student, Nursing Science Program
Universitas Muhammadiyah Surakarta