Intervention to Enhance Numeracy in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Change in Objective Diabetes Numeracy from Baseline to ≈6 weeks
研究概览
简要总结
The objective of this project is to test two interventions designed to improve diabetes-related numeracy. Numeracy is the ability to understand and use numbers. People with diabetes use numbers in a variety of ways in managing their condition (e.g., understanding blood sugar values, counting carbohydrates, taking medications at the right dose and time). As part of this project, the investigators developed and pilot tested two interventions to improve diabetes-related numeracy: (1) a series of in-person education classes and (2) a one-time, online diabetes education class. The investigators will look to see whether participants in the education classes show improvements in their diabetes-related numeracy skills, self-care behavior and attitudes, and clinical outcomes (i.e., body mass index, blood pressure, blood sugar [A1c]).
详细描述
Sixty-five American Indians with diabetes were enrolled. Each participant was randomly assigned to 1 of 3 study arms: (1) the in-person education group, (2) the online education group, and (3) a control group. The in-person intervention group attended four class sessions addressing numeracy skills used in the management of diabetes (e.g., counting carbohydrates). The online education group completed a single online module providing training on diabetes-related numeracy skills. The control group received written diabetes educational materials. The investigators collected data at baseline, then again immediately after intervention participation (in-person or online classes), and one final time about three months after the conclusion of the intervention. The investigators will conduct analyses to determine if intervention participants experienced positive changes in diabetes numeracy (the primary outcome) as well as several secondary outcome measures following intervention. Secondary outcomes include: diabetes knowledge, self-efficacy, outcome expectancies, readiness to change, self-care behavior, and clinical outcomes (i.e., body mass index, blood pressure, blood sugar [A1c]) . The investigators also will assess whether change in numeracy predicts change in these secondary outcomes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Indian/Alaska Native;
- •18 to 89 years old;
- •diabetes diagnosis documented in medical records;
- •active patient of the Yakama Indian Health Service.
排除标准
- •Does not speak English;
- •pregnancy;
- •dialysis;
- •current cancer treatment;
- •blindness;
- •active alcohol/substance abuse;
- •planning to move out of the area in the next six months.
研究组 & 干预措施
In-Person Diabetes Numeracy Education
Participants randomized to the in-person education group attended four group classes, each addressing a specific set of diabetes self-care skills (i.e., understanding and using blood glucose numbers, counting carbohydrates, taking medications at the right dose and time). So that each class included a stable group of 8 and 16 participants, we ran classes in "cohorts" of 8-16 people. A participant always attended classes with his/her cohort.
干预措施: In-Person Diabetes Numeracy Education (Behavioral)
Online Diabetes Numeracy Education
Participants randomized to the online education group attended a single session, at which he/she completed a computerized education module that addressed understanding blood sugar values and using them to examine the impact of food, exercise, and medicines on blood sugar.
干预措施: Online Diabetes Numeracy Education (Behavioral)
Control
Participants were given written educational materials about diabetes.
结局指标
主要结局
Change in Objective Diabetes Numeracy from Baseline to ≈6 weeks
时间窗: ≈6 weeks
Adapted version of the Diabetes Numeracy Test
次要结局
- Change in Objective Diabetes Numeracy from Baseline to ≈3 months(≈3 months)
- Change in Subjective Numeracy from Baseline to ≈6 weeks(≈6 weeks)
- Change in Subjective Numeracy from Baseline to ≈3 months(≈3 months)
- Change in Diabetes Knowledge from Baseline to ≈6 weeks(≈6 weeks)
- Change in Diabetes Knowledge from Baseline to ≈3 months(≈3 months)
- Change in Diabetes Self-Efficacy from Baseline to ≈6 weeks(≈6 weeks)
- Change in Diabetes Self-Efficacy from Baseline to ≈3 months(≈3 months)
- Change in Diabetes Self-Care Behavior from Baseline to ≈6 weeks(≈6 weeks)
- Change in Diabetes Self-Care Behavior from Baseline to ≈3 months(≈3 months)
- Change in Body Mass Index from Baseline to ≈6 weeks(≈6 weeks)
- Change in Body Mass Index from Baseline to ≈3 months(≈3 months)
- Change in Blood Pressure from Baseline to ≈6 weeks(≈6 weeks)
- Change in Blood Pressure from Baseline to ≈3 months(≈3 months)
- Change in Outcome Expectancies from Baseline to ≈6 weeks(≈6 weeks)
- Change in Outcome Expectancies from Baseline to ≈3 months(≈3 months)
- Change in Readiness to Change from Baseline to ≈6 weeks(≈6 weeks)
- Change in Readiness to Change from Baseline to ≈3 months(≈3 months)
- Change in Glycemic Control from Baseline to ≈3 months(≈3 months)