Family Model of Diabetes Self-Management Education in the Marshallese Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 2
- 主要终点
- Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
研究概览
简要总结
The investigators will conduct a comparative effectiveness evaluation using a randomized control trial design of a culturally adapted family model of Diabetes Self-Management Education (Adapted DSME) compared with Standard DSME within the Marshallese population. The family model will cover the same concepts as the standard format. However, the family model will incorporate culturally-adapted education and recommendations aimed at engaging family members in the management of the primary participant's diabetes, and family members will be invited to fully participate in the study. By contrast, the standard model provides diabetes self- management education to the diabetic participant only, and the participant's family members do not participate in the classes or any other part of the study. Biometric and survey data will be collected pre-intervention, post-intervention, 6 months post-intervention, and 12 months post-intervention. A qualitative debriefing session will be held for each family between the final DSME session and the 6 month post-intervention to obtain qualitative data regarding the participant's perceptions of the intervention and implementation process.
详细描述
Background and Rationale
The Marshallese population suffers from a significant and disproportionate burden of type 2 diabetes. The rate of type 2 diabetes among the Marshallese is one of the highest of any population group in the world-at least 400% higher than the general US population.1-7 Our systematic review of local, national, and international data found estimates of diabetes in the Marshallese (populations living both in the US and Marshall Islands) ranging from 30% to 50% compared to 8.3% for the US population and 4% worldwide.4-7 Causes for this disparity have not been completely unraveled and are partially embedded in the history of the Marshall Islands. Between 1946 and 1958, the US military tested nuclear weapons on several of the Marshall Islands. People who inhabited the bombed islands and atolls were relocated, but Marshallese living on nearby atolls that were not evacuated experienced nuclear fallout during and after nuclear tests. Because of the nuclear testing, the Atomic Energy Commission lists the Marshall Islands as one of the most contaminated places in the world, and several studies demonstrate ongoing health effects from the nuclear testing.8 The nuclear contamination resulted in significant and long-term changes in diet and lifestyle of the Marshallese.9-12 These changes in diet and lifestyle have contributed to an increased rate of type 2 diabetes.2-5,16-19 The Compact of Free Association between the Republic of the Marshall Islands (RMI) and the US, signed in 1986, permits the US to conduct military activities in the Marshall Islands and also allows Marshallese individuals to come to the US without a visa. The Marshallese population living in the US tripled between 2000 and 2010, with Arkansas having the largest population of Marshallese living outside of the RMI.
Diabetes self-management education (DSME) is an evidence-based model that has been shown to improve glycemic control, reduce diabetic complications, and reduce the cost of managing diabetes. Standard implementation approaches of DSME have not been effective in Marshallese populations, indicating that a unique approach tailored to this population is needed.2-3 Because of the disproportionate burden of diabetes and related complications experienced by this high-risk population, a novel adaptation of the evidence-based DSME model and subsequent testing in a community-based setting are needed.
Using a Community Based Participatory Research (CBPR) approach, we have conducted four focus groups and individual interviews with the Marshallese community to better understand how to best address the well-established need for diabetes education. Through interviews and focus groups, Marshallese participants pointed out that the delivery method and the concept of self-management as an individual experience are problematic components. DSME was designed with a very Western societal approach, which is highly individualistic. The Marshallese have a highly collectivist culture and the idea of -self‖ management is counter to their cultural values. As stakeholders described, -we eat together from one pot. For one person to refuse the food from that one pot is not just inconvenient, it is shameful. It shames the person and the person's family. It is not an acceptable option. We will not do it. The interviewees stated that any changes must be a family change. Incorporating collectivist and family concepts into the delivery mechanism is imperative. Through the interviews and focus groups, the Marshallese community suggested that DSME be implemented within a family model with a family group receiving DSME so that the entire family can benefit and the patient can be supported in their effort to make lifestyle changes. Because ~30-50% of the Marshallese community have type 2 diabetes, this approach could be even more beneficial.
Hypothesis and/or Specific Aims or Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Primary Participant:
- •Must be 18 years or older
- •Self-reported Diabetes Mellitus Type 2 diagnosis by a health care provider
- •Self-reported Marshallese ethnicity or descent
- •Secondary (Family) Participant:
- •Must be 18 years or older
排除标准
- •Younger than 18
研究组 & 干预措施
Standard DSME
Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
干预措施: Standard DSME (Behavioral)
Adapted DSME
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
干预措施: Adapted DSME (Behavioral)
结局指标
主要结局
Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
时间窗: Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention
A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant. The primary outcome measure was change in adjusted mean HbA1c (%) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants. The mean HbA1c values presented here have been adjusted, whereas the mean HbA1c values presented in the Baseline Data section are unadjusted.
次要结局
- Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily(Baseline, 12 months post-intervention)
- Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention(Baseline, Immediate post-intervention; 6 months post-intervention; 12 months post-intervention)
- Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.(Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention)
- Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.(Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention)
- Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months(Baseline, 12 Months Post-Intervention)
- Change in Mean Triglycerides From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention(Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention)
- Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Seen Doctor or Other Health Professional in Past 12 Months for Diabetes(Baseline, 12 months post-intervention)
- Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight(Baseline, 12 Months Post-Intervention)
- Change in Mean Low-density Lipoproteins (LDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention(Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention)
- Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity(Baseline, 12 Months Post-Intervention)
- Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Foot Exam by Doctor or Other Health Professional in Past 12 Months(Baseline, 12 Months Post-Intervention)
- Change in Mean Fasting Glucose From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention(Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention)