Improving Diabetes Efforts Across Language and Literacy (IDEALL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 339
- 试验地点
- 2
- 主要终点
- Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
研究概览
简要总结
The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies. A communication technology-based intervention (automated telephone diabetes management) and an interpersonally-oriented intervention (group medical visits)will be compared to usual care for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net health centers in the University of California, San Francisco (UCSF) Collaborative Research Network.
详细描述
See above
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
- None
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
- •have type 2 diabetes
- •have a HbA1c equal to or > 8.0%
- •must speak English, Spanish, or Cantonese.
排除标准
- •Psychosis/Schizophrenia
- •End Stage Renal Disease
结局指标
主要结局
Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
时间窗: Baseline and 1 year
The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores can be derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. The Diabetes Self-management Behaviors score is used in this study. For this score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior. Change is calculated as 1-year score minus baseline score.
Changes in Minutes of Moderate Physical Activity
时间窗: Baseline and 1 year
A measure of patients' physical activity is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do physical activity? Like walking, house cleaning or gardening." Number of minutes may range from 0 to 10080, with greater number of minutes indicating more physical activity.
Changes in Minutes of Vigorous Exercise
时间窗: Baseline and 1 year
A measure of patients' vigorous exercise is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do the kind of exercise that makes you breathe hard, such as swimming, walking fast, or biking?" Number of minutes may range from 0 to 10080, with greater number of minutes indicating more vigorous exercise.
次要结局
- Changes in Patient Assessment of Chronic Illness Care (PACIC)(Baseline and 1 year)
- Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale(Baseline and 1 year)
- Changes in Interpersonal Processes of Care (IPC) Scale(Baseline and 1 year)
- Changes in the Physical Component Summary of the SF-12 Health Survey(Baseline and 1 year)
- Changes in the Mental Component Summary of the SF-12 Health Survey(Baseline and 1 year)
- Number of Days Spent in Bed Due to Health Problems(1 year)
- Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities(1 year)
- Changes in Hemoglobin A1c Levels(Baseline and 1 year)
- Changes in Systolic Blood Pressure (SBP)(Baseline and 1 year)
- Changes in Diastolic Blood Pressure (DBP)(Baseline and 1 year)
- Changes in Body Mass Index (BMI)(Baseline and 1 year)