Improving Diabetes Efforts Across Language and Literacy (IDEALL)
2013年2月12日 更新者:Agency for Healthcare Research and Quality (AHRQ)
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.
研究概览
详细说明
See above
研究类型
介入性
注册 (实际的)
339
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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California
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San Francisco、California、美国、94143-1364
- Ucsf Dept of Medicine Box 1364
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- have type 2 diabetes
- have a HbA1c equal to or > 8.0%
- must speak English, Spanish, or Cantonese.
Exclusion Criteria:
- Dementia
- Psychosis/Schizophrenia
- End Stage Renal Disease
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:ATSM Intervention
ATSM Intervention: Automated Telephone Self-Management Support
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Participants randomized to ATSM Intervention received weekly, automated (pre-recorded) telephone calls over 39 weeks (9 months).
Patient responses triggered either immediate, automated health education messages and/or subsequent nurse phone follow-up.
其他名称:
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有源比较器:GMV Intervention
GMV Intervention: Group Medical Visits
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GMV Intervention involved 90-minute monthly sessions over 9 months, involving 6-10 participants, co-facilitated by a primary care physician and health educator.
其他名称:
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无干预:Usual Care
Usual Care: Standard care for diabetic patients
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
大体时间:Baseline and 1 year
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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.
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Baseline and 1 year
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Changes in Minutes of Moderate Physical Activity
大体时间:Baseline and 1 year
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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.
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Baseline and 1 year
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Changes in Minutes of Vigorous Exercise
大体时间:Baseline and 1 year
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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.
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Baseline and 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Patient Assessment of Chronic Illness Care (PACIC)
大体时间:Baseline and 1 year
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The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past year that are aligned with the Chronic Care Model.
The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support.
Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care.
Scores are transformed to a 100-point scale and averaged across all items to create a total scale score.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
大体时间:Baseline and 1 year
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The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project.
The scale is designed to reflect patients' assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care).
Respondents are asked how difficult over the past year has it been to follow exactly as their doctor who takes care of their diabetes suggested.
Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy.
Total scale score is calculated as the average across all items.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in Interpersonal Processes of Care (IPC) Scale
大体时间:Baseline and 1 year
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The Interpersonal Processes of Care (IPC) captures patient reports of providers' communication over the prior year.
The scale is intended to measure patients' assessment of providers' communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness).
Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score.
Higher total scores indicate better communication.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in the Physical Component Summary of the SF-12 Health Survey
大体时间:Baseline and 1 year
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The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes.
The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Two summary measures are derived: the Physical and the Mental Health Component Summary.
For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in the Mental Component Summary of the SF-12 Health Survey
大体时间:Baseline and 1 year
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The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes.
The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Two summary measures are derived: the Physical and the Mental Health Component Summary.
For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Number of Days Spent in Bed Due to Health Problems
大体时间:1 year
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A measure of patients' functional status is ascertained by asking patients the following question: "In the last 30 days, how many days did your health keep you in bed all or most of the day?" Number of days may range from 0 to 30, with lower number of days indicating better functional status.
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1 year
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Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
大体时间:1 year
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A measure of diabetes interference on patients is ascertained by asking patients the following question: "In the last 12 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?"
Responses consist of 6 possible options: "Always", "Almost Always", "Often", "Sometimes", "Almost Never", and "Never".
These responses are grouped into 2 categories, with one category consisting of "Always", "Almost Always", and "Often" responses while the other category consists of the remaining responses.
The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.
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1 year
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Changes in Hemoglobin A1c Levels
大体时间:Baseline and 1 year
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Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way.
This serves as a marker for average blood glucose levels over the previous months prior to the measurement.
Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease.
Change is calculated as 1-year level minus baseline level.
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Baseline and 1 year
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Changes in Systolic Blood Pressure (SBP)
大体时间:Baseline and 1 year
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Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body.
Change is calculated as 1-year pressure minus baseline pressure.
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Baseline and 1 year
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Changes in Diastolic Blood Pressure (DBP)
大体时间:Baseline and 1 year
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Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood.
Change is calculated as 1-year pressure minus baseline pressure.
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Baseline and 1 year
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Changes in Body Mass Index (BMI)
大体时间:Baseline and 1 year
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Body Mass Index (BMI) is a number calculated from a person's weight and height.
BMI is defined as the individual's body mass divided by the square of their height.
The formulae used produce a unit of measure of kg/m2.
BMI provides an indicator of body fatness.
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Baseline and 1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Dean Schillinger, MD、University of California, San Francisco
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2002年11月1日
初级完成 (实际的)
2005年11月1日
研究完成 (实际的)
2005年11月1日
研究注册日期
首次提交
2005年9月19日
首先提交符合 QC 标准的
2005年9月19日
首次发布 (估计)
2005年9月22日
研究记录更新
最后更新发布 (估计)
2013年2月13日
上次提交的符合 QC 标准的更新
2013年2月12日
最后验证
2013年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.