Putting CDSMP to Work: Implementation of the Live Healthy, Work Healthy Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 13
- 主要终点
- blood glucose examining change at 6 and 12 months
研究概览
简要总结
This project is the test of the effectiveness of the Chronic Disease Self-Management Program which will be translated to a worksite setting.
详细描述
This project will test adaptations of the Chronic Disease Self-Management Program (CDSMP) designed to increase the likelihood of widespread use in workplace settings. CDSMP, which has been proven efficacious in community trials, is a six-week program that is designed to help individuals better manage their chronic disease and its many complications. Although there is considerable interest among worksite health promotion practitioners for a chronic disease program, CDSMP has not been adapted and tested in workplace settings. In this study, we will determine a) if the CDSMP program tailored to worksites can be efficacious, b) the comparative effectiveness of the worksite tailored CDSMP when compared to the original CDSMP and c) the cost-effectiveness (average and incremental) and return on investment of the two interventions. The participating sites are seven organizations from a rural county in Southwest Georgia. Our partner for the project is the local YMCA. YMCA staff will be trained to implement the program which will foster sustainability. Participants will be randomly assigned to 1) workplace-tailored CDSMP, 2) 'usual care' CDSMP, and 3) control group. Data will collected at baseline, 6-month follow-up and 12-months follow-up. The control group will be a delayed intervention group that will be randomly assigned to an intervention group after taking the 6 month survey. The primary outcome measures include blood pressure, cholesterol, blood glucose, BMI, diet, physical activity and tobacco use and the secondary measures including patient-provider communication, quality of life, medical adherence, and work performance and productivity. An average cost-effectiveness analysis will compare interventions to control and an incremental cost-effectiveness analysis will be conducted comparing each intervention to one another. The hypotheses will be tested using a growth modeling approach examining changes over time. This will enable us to maximize the dissemination and implementation of CDSMP across worksite populations by using approaches which are realistic for most work organizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The primary target is all employees 45 years or above with levels of gender and ethnicity similar to those found in the workplaces with which we will work.
- •If younger individuals wish to participate, we will not turn them away but the program is designed for older adults. It is unlikely we will get a substantial number of participants over 45.
排除标准
- 未提供
研究组 & 干预措施
workplace-tailored CDSMP
Group will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace.
干预措施: Workplace-tailored CDSMP (Behavioral)
CDSMP usual care
Group will receive the standard CDSMP program which is currently being offered in a variety of community settings.
干预措施: Chronic Disease Self-Management Program (Behavioral)
control
Group will receive no intervention for the first 6 months (pre / post), then be randomly assigned to one of the above interventions.
结局指标
主要结局
blood glucose examining change at 6 and 12 months
时间窗: baseline, six months, one year
blood glucose levels
Cholesterol levels examining change at 6 and 12 months
时间窗: baseline, six months, one year
HDL, LDL, and total cholesterol levels
Cardiovascular risk scale examining change at 6 and 12 months
时间窗: baseline, six months, one year
Overall measure taken from the Framing Heart Study which includes: systolic blood pressure, total cholesterol, HDL cholesterol, BMI, gender, age, use of antihypertensive treatment, smoking and diabetes mellitus status.
Physical activity (Measure of moderate-intensity physical activities) examining change at 6 and 12 months
时间窗: baseline, six months, one year
Measure of moderate-intensity physical activities.
Sedentary behavior (Measures total time spent sitting in transport, work and leisure) examining change at 6 and 12 months
时间窗: baseline, six months, one year
Measures total time spent sitting in transport, work and leisure.
Eating behaviors (Food propensity questionnaire) examining change at 6 and 12 months
时间窗: baseline, six months, one year
Food propensity questionnaire used to estimate usual intake for food items and food groups.
Body Mass Index examining change at 6 and 12 months
时间窗: baseline, six months, one year
Measure of obesity using height and weight
Tobacco use examining change at 6 and 12 months
时间窗: baseline, six months, one year
Measure of current and past tobacco use.
blood pressure examining change at 6 and 12 months
时间窗: baseline, six months, one year
diastolic and systolic measures
次要结局
- Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months(baseline, six months, one year)
- Self-assessed quality of life scale examining change at 6 and 12 months(baseline, six months, one year)
- Sleep (Visual analogue scale) examining change at 6 and 12 months(baseline, six months, one year)
- Fatigue (Visual analogue scale) examining change at 6 and 12 months(baseline, six months, one year)
- Quality of life (EQ-5D) scale examining change at 6 and 12 months(baseline, six months, one year)
- Prescription medication adherence examining change at 6 and 12 months(baseline, six months, one year)
- Stress (Visual analogue scale) examining change at 6 and 12 months(baseline, six months, one year)
- Well-being (SF-12) scale examining change at 6 and 12 months(baseline, six months, one year)
- Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 months(baseline, six months, one year)
- Pain (Visual analogue scale) examining change at 6 and 12 months(baseline, six months, one year)
研究者
Mark Wilson
Associate Dean for Academic Affairs
University of Georgia