Peer-lead and Telemedicine Activated Care (PACT) in Diabetes Prevention and Management
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- Compare changes in self-efficacy between participants receiving peer-led care (with or without TAP intervention) and those receiving UC over 12 months.
研究概览
简要总结
The prevalence of obesity and diabetes in older adults is increasing. Because older adults are often portrayed as less likely to change long-standing health behaviors, health promotion in this age group has lagged behind others. In fact, little attention has been given to the importance of diabetes prevention in community-dwelling older adults through the implementation of programs that promote healthy nutrition, increase physical activity and improve self-management. The Diabetes Prevention Program (DPP), which demonstrated the benefit of modest weight loss on the reduction of diabetes risk (58% overall reduction with a 71% reduction in the older population), has yet to be translated into widespread public health practice.
The overall objective of this protocol is to implement evidence-informed, innovative interventions to increase adoption of findings from comparative effectiveness research (CER) for diabetes management and prevention in South Florida older veterans. Specifically, the proposed study will test the hypothesis that Peer-led Care alone (PC), or activated by technology (TechnAlert-Peer or TAP), is superior to traditional methods of information dissemination (Usual Care or UC) for adoption of CER on prevention and management of diabetes, leading to better self-efficacy and clinical outcomes.
The investigators will conduct a 12-month randomized controlled trial in older veterans with prediabetes and diabetes participating in one of the Healthy Aging Regional Collaborative programs. Primary outcomes include changes in self-efficacy, weight, and hemoglobin A1c. Secondary outcomes include changes in blood pressure, lipids, physical function, quality of life, and health care utilization and the evaluation of potential racial/ethnic disparities in the process of adoption of CER for prevention and management of diabetes.
This study is expected to accelerate the implementation of CER evidence for diabetes prevention, addressing health and economic challenges in the care of overweight and obese veterans.
详细描述
The prevalence of obesity and diabetes in older adults has increased during the past 20 years and will increasingly affect medical and social services, as well as costs over time. Because older adults are often portrayed as less likely to change long-standing health behaviors, health promotion in this age group has lagged behind others. In fact, little attention has been given to the importance of diabetes prevention and management in community-dwelling older adults.
A recent report of obesity diagnosis and care practice in the Veterans Health Administration showed that elderly patients were less likely to receive obesity-related education or counseling [Noel 2010]. Intentional weight loss in obese older adults has not been widely advocated by health care providers due to the perceived uncertainty of whether the benefits outweigh the risks. There is also a need to overcome the barriers to provide appropriate interventions on blood pressure, glucose, and lipid management tailored to the functionality of older adults.
The Diabetes Prevention Program (DPP) demonstrated the benefit of modest weight loss, through diet and exercise, on the reduction of diabetes risk in participants from all race/ethnic groups (58% overall reduction with a 71% reduction in the older population), leading to a delay of 4 years over a 10-year period in the onset of diabetes among those that received lifestyle intervention [DPP 2002, DPP 2009]. The DPP is considered a landmark study in comparative effectiveness research (CER), but it has yet to be translated into widespread public health practice.
South Florida provides a unique setting to accelerate the adoption of this CER evidence into practice and address the obesity and diabetes challenges of the aging population. There are more than 800,000 multi-ethnic residents age 60 and over, many of whom have one or more chronic diseases [CDC 2008]. A large number of older veterans with or at high-risk of diabetes currently receive care in the Miami VA Healthcare System.
Compelling scientific evidence exists that lifestyle change delays the onset of type 2 diabetes in high-risk persons. Lifestyle intervention can also lead to a reduction in cardiovascular risk factors in individuals with type 2 diabetes [Look AHEAD research group 2007]. However, few older adults succeed in achieving intentional weight loss through healthy diet and increased physical activity. Furthermore, some have argued that the current US health system is not prepared to deliver lifestyle interventions [Narayan 2004].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years and older
- •Enrolled in HARC program
- •Body mass index (BMI) ≥ 25 kg/m²
- •Diagnosed diabetes or prediabetes [ADA 2003 criteria] HbA1c ≥ 5.7%
- •Able to operate a telemedicine device, respond to text queries, and use his/her glucose meter, a blood pressure monitor, and a scale for daily weights
排除标准
- •End-stage illness
- •Anticipated survival less than 12 months
- •Imminent nursing home placement
- •Diagnosis of psychosis or significant cognitive impairment/dementia
结局指标
主要结局
Compare changes in self-efficacy between participants receiving peer-led care (with or without TAP intervention) and those receiving UC over 12 months.
时间窗: 12 months
Compare changes in weight and hemoglobin A1c between participants receiving peer-led care (with or without TAP intervention) and those receiving UC over 12 months.
时间窗: 12 months
次要结局
- Compare changes in weight, hemoglobin A1c, and self-efficacy between white-non-hispanics and minorities over 12 months.(12 months)
- Compare changes in blood pressure, lipids, physical function, and quality of life among treatment groups (UC, PC, and TAP).(12 months)
- Compare changes in health care utilization (physician visits, emergency visits, and days in hospital) among treatment groups (UC, PC, and TAP).(12 months)
