Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 主要终点
- HbA1c
研究概览
简要总结
To evaluate the effectiveness of the Farsi diabetes self-management education program on psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with type 2 diabetes and those with already-diagnosed type two diabetes who had received little self-management education. The development of the program was guided by an innovative process of intervention planning: Intervention Mapping.
详细描述
For designing the management program, we will use Intervention Mapping (IM) framework for systematically developing the theory and evidence based program.
Based on IM approach, this study will have seven phases:
Step 1: needs assessment (Development the problem analysis: health, quality of life, behavior, environment).
Step 2: We will develop proximal program objectives with a multidisciplinary expert panel of participants.
Step 3: After identification of the proximal program objectives, the next step will be to select theoretical methods and practical strategies based on evidence for alternative methods.
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
- Double (Participant, Outcomes Assessor)
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
- •Diagnosed with type 2 diabetes (according to the WHO criteria)
- •Older than 18 years
排除标准
- •Pregnancy
- •Unable to participate in a group program (for example, housebound or unable to communicate in Farsi)
- •Having reduced cognitive ability
研究组 & 干预措施
FDSME group
In the FDSME group, sessions will be held interactive; and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions.
干预措施: FDSME group (Behavioral)
Control group
干预措施: FDSME (Behavioral)
结局指标
主要结局
HbA1c
时间窗: within 2 years
BMI
时间窗: 2 years
次要结局
- Audit of Diabetes-Dependent Quality of Life (ADDQOL)(two years)