Development of Telenursing for Diabetes Self-Management Education and Support (DSMES) Among Patients With Type 2 Diabetes Mellitus in Thailand: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Feasibility of telenursing for diabetes self-management education and support (DSMES)
研究概览
简要总结
This randomized controlled trial aims to develop and evaluate a telenursing-based Diabetes Self-Management Education and Support (DSMES) program with uncontrolled type 2 diabetes mellitus in Thailand. The program is designed to improve diabetes self-management through nurse-led education, behavioral support, and regular follow-up delivered via telecommunication technologies.
Participants with type 2 diabetes and poor glycemic control will be randomly assigned to either an intervention group receiving a 12-week telenursing DSMES program or a control group receiving usual care. The intervention includes an initial in-person education session followed by structured video call follow-ups provided by nurse.
The primary outcome of this study is the feasibility of implementing telenursing for DSMES in Thailand. Secondary outcomes include changes in glycemic control (HbA1C , FBG), blood pressure, body mass index, diabetes knowledge, self-care behaviors, coping behaviors, quality of life, healthcare costs, and frequency of acute care use. The findings from this study are expected to provide evidence to support the use of telenursing as an accessible and sustainable approach for diabetes self-management in the Thai healthcare context.
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)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with T2DM
- •Adults (age 20-64) and older adults (65 and above)
- •Uncontrolled diabetes, as determined by physician based on the diagnostic criteria of HbA1C > 7%
- •Can read and write
- •Own a smartphone
- •Having internet connectivity
- •Able to receive a video call or with assistance from a caregiver
排除标准
- •Insulin-dependent patients
- •Cognitive or mobility impairments , as assessed by the Thai Mental State Examination (TMSE). A TMSE score below 24 was considered indicative of cognitive impairment (The Nurse Association of Thailand, 2025).
- •Requiring special nursing care, such as patients with severe diabetic complications or those who are bedridden.
- •Previous extensive DSMES exposure
研究组 & 干预措施
Usual care
control group : receive usual care
Telenursing-Based DSMES Program
干预措施: Telenursing-Based Diabetes Self-Management Education and Support (Behavioral)
结局指标
主要结局
Feasibility of telenursing for diabetes self-management education and support (DSMES)
时间窗: at 12-week follow-up period after enrollment
Feasibility outcomes, including participation rate, completion rate, and adherence level, were analyzed using descriptive statistics under the per-protocol (PP) approach, which included only participants who completed all study assessments.
次要结局
- Glycated hemoglobin (HbA1c) level(From baseline to 12 weeks after enrollment)
- Body Mass Index (BMI)(From baseline to 12 weeks after enrollment)
- Change from baseline in diabetes knowledge score measured by the Diabetes Knowledge Scale (DIAKS)(From baseline to 6 weeks and 12 weeks after enrollment)
- Self-care behavior(From baseline to 6 weeks and 12 weeks after enrollment)
- Positive coping behavior(From baseline to 6 weeks and 12 weeks after enrollment)
- Quality of life (QoL)(From baseline to 6 weeks and 12 weeks after enrollment)
- Healthcare costs(at 12-week follow-up period after enrollment)
- Frequency of acute care use(at 12-week follow-up period after enrollment)
- All-cause mortality(at 12-week follow-up period after enrollment)
研究者
Ramida Subpaiboonkit
Principal Investigator, Lecturer
Chiang Mai University