Putting CDSMP to Work
- Conditions
- Cardiovascular DiseasesChronic Disease
- Interventions
- Behavioral: Workplace-tailored CDSMPBehavioral: Chronic Disease Self-Management Program
- Registration Number
- NCT02409056
- Lead Sponsor
- University of Georgia
- Brief Summary
This project is the test of the effectiveness of the Chronic Disease Self-Management Program which will be translated to a worksite setting.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- 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.
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description workplace-tailored CDSMP Workplace-tailored CDSMP Group will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace. CDSMP usual care Chronic Disease Self-Management Program Group will receive the standard CDSMP program which is currently being offered in a variety of community settings.
- Primary Outcome Measures
Name Time Method blood glucose examining change at 6 and 12 months baseline, six months, one year blood glucose levels
Cholesterol levels examining change at 6 and 12 months baseline, six months, one year HDL, LDL, and total cholesterol levels
Cardiovascular risk scale examining change at 6 and 12 months 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 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 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 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 baseline, six months, one year Measure of obesity using height and weight
Tobacco use examining change at 6 and 12 months baseline, six months, one year Measure of current and past tobacco use.
blood pressure examining change at 6 and 12 months baseline, six months, one year diastolic and systolic measures
- Secondary Outcome Measures
Name Time Method Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months baseline, six months, one year Measure of communication with a physician.
Self-assessed quality of life scale examining change at 6 and 12 months baseline, six months, one year CDC Healthy Days quality of life measure.
Sleep (Visual analogue scale) examining change at 6 and 12 months baseline, six months, one year Visual analogue scale to determine symptoms of chronic disease.
Fatigue (Visual analogue scale) examining change at 6 and 12 months baseline, six months, one year Visual analogue scale to determine symptoms of chronic disease.
Quality of life (EQ-5D) scale examining change at 6 and 12 months baseline, six months, one year Measure of quality of life (EQ-5D).
Prescription medication adherence examining change at 6 and 12 months baseline, six months, one year Measures medication compliance.
Stress (Visual analogue scale) examining change at 6 and 12 months baseline, six months, one year Visual analogue scale to determine symptoms of chronic disease.
Well-being (SF-12) scale examining change at 6 and 12 months baseline, six months, one year Measure of functional health and well-being (SF-12).
Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 months baseline, six months, one year Personal Health Questionnaire Depression Scale (PHQ8).
Pain (Visual analogue scale) examining change at 6 and 12 months baseline, six months, one year Visual analogue scale to determine symptoms of chronic disease.
Trial Locations
- Locations (13)
Colquitt Regional Medical Center
🇺🇸Moultrie, Georgia, United States
National Beef
🇺🇸Moultrie, Georgia, United States
City of Moultrie
🇺🇸Moultrie, Georgia, United States
Colquitt County Schools
🇺🇸Moultrie, Georgia, United States
Wiregrass Technical College
🇺🇸Valdosta, Georgia, United States
Southwest Georgia Community Action Council
🇺🇸Moultrie, Georgia, United States
Lowndes County
🇺🇸Valdosta, Georgia, United States
Southwest Georgia Bank
🇺🇸Moultrie, Georgia, United States
Southwest Regional Technical College
🇺🇸Moultrie, Georgia, United States
Madison County Schools
🇺🇸Danielsville, Georgia, United States
Colquitt County Government
🇺🇸Moultrie, Georgia, United States
Turning Point Hospital
🇺🇸Moultrie, Georgia, United States
Valdosta City Schools
🇺🇸Valdosta, Georgia, United States