A Patient-Centered Framework to Test the Comparative Effectiveness of Culturally and Contextually Appropriate Program Options for Latinos With Diabetes From Low-Income Households
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 2
- 主要终点
- Patients will improve their capacity for diabetes self-management: Measured through change in Diabetes Knowledge
研究概览
简要总结
BACKGROUND AND SIGNIFICANCE:
Diabetes is a national health problem, yet Latinos from low-income households are at greater risk. Although guidelines recommend that patients learn self-management strategies, many people are not able to do so effectively and cannot control their diabetes. Studies show that culturally competent self-management programming can help, but patients in preliminary research indicated that not all programs sufficiently respect patients' cultural values or account for their socio-economic limitations.
STUDY AIMS:
This project will compare two models for culturally competent diabetes self-management programming. The hypothesis is that the program model that best considers patient culture and accommodates patient socio-economic circumstances will have the best outcomes.
COMPARATORS:
2 diabetes self-management program models used by many Latino patients from low-income households in Albuquerque, New Mexico
- The Diabetes Self-Management Support Empowerment Model
- The Chronic Care Model
STUDY POPULATION:
Patients will be 240 individuals who consider themselves to be Latino and who are from low-income households. In addition, 240 patients will identify a corresponding social support to participate with them. Outcomes will be measured based on the 240 patient participants. Social support data will be measured as a covariate to understand patient outcomes.
PRIMARY OUTCOME:
Improved capacity for diabetes self-management measured as diabetes knowledge and patient activation or the ability to put that knowledge into action.
SECONDARY OUTCOME:
Successful diabetes self-management measured through reduced A1c, BMI and depression. Patient stress levels will also be measured using testing of hair samples to identify levels of cortisol as a biological marker for chronic stress.
METHODS:
Statistical calculations will be conducted to make sure that the things being compared are differences in program design and not differences in individual patient characteristics. This study will compare whether the programs improve diabetes health knowledge, ability to act, and A1c, BMI, depression and stress control, and determine which program is the best.
详细描述
BACKGROUND AND SIGNIFICANCE:
Diabetes is a national health priority but diabetes risk is extremely high for Latinos from low-income households. Health guidelines recommend that individuals learn strategies to self-management their diabetes, but getting people to adopt required lifestyle changes is challenging and many people are not able to prevent their pre-diabetes from escalating or to control their diabetes. Systematic reviews show that culturally competent self-management programming can significantly improve diabetes outcomes, and different models for culturally competent programming have been developed.
STUDY AIMS:
The goal of this study is to compare the effectiveness of 2 distinct evidence-based models for culturally competent diabetes health promotion. The hypothesis is that the program model that interfaces most synergistically with patient's culture and everyday life circumstances will have the best diabetes health outcomes.
Aim 1: Characterize the ways that three culturally competent diabetes self-management programs interface with patient culture and socioeconomic context
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Prisoners
- •Pregnant women
- •Participants who become pregnant during the study will be excluded. At enrollment and before each data collection appointment, female patient participants will be screened to specifically exclude those who are pregnant. There is no risk to a pregnant woman or a fetus entailed in participation in this study because the study only involves data collection from individuals who have been instructed to participate in a diabetes self-management program by their provider. However, pregnant individuals will be excluded because pregnancy could impact outcomes in a way that will influence scientific analysis of diabetes self-management.
结局指标
主要结局
Patients will improve their capacity for diabetes self-management: Measured through change in Diabetes Knowledge
时间窗: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Improvement in diabetes knowledge measured through change in scores on The Diabetes Knowledge Questionnaire \[DKQ\])
Patients will improve their capacity for diabetes self-management: Measured through change in Patient Activation
时间窗: (baseline to 3 months), (3 months to 6 months), (6 months to 12 months)
Improvement in patient ability to manage their own diabetes measured through changes in score on the Patient Activation Measure (PAM)
次要结局
- Patients will successfully self-manage their diabetes as measured through change (reduction) in depression((baseline to 3 months), (3 months to 6 months), (6 months to 12 months))
- Patients will successfully self-manage their diabetes measured through change (reduction) in their blood glucose((baseline to 3 months), (3 months to 6 months), (6 months to 12 months))
- Patients will successfully self-manage their diabetes measured through change (reduction) in Body Mass Index (BMI)((baseline to 3 months), (3 months to 6 months), (6 months to 12 months))
- Patients will successfully self-manage their diabetes as measured though change (reduction) in chronic stress levels((baseline to 6 months), (6 months to 12 months))
研究者
Janet M Page-Reeves
Research Assistant Professor
University of New Mexico