Putting CDSMP to Work

Study Overview
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Brief Summary
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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
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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.

Official Title
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Putting CDSMP to Work: Implementation of the Live Healthy, Work Healthy Program

Conditions
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Chronic Disease, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Workplace-tailored CDSMP
* Behavioral: Chronic Disease Self-Management Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: workplace-tailored CDSMP<br>Group will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace. | Behavioral: Workplace-tailored CDSMP<br>* This is the CDSMP program which has been modified to fit the unique characteristics of the workplace and will be offered in worksites.<br>* Other names: Live Healthy Work Healthy Program;|
| Active Comparator: CDSMP usual care<br>Group will receive the standard CDSMP program which is currently being offered in a variety of community settings. | Behavioral: Chronic Disease Self-Management Program<br>* This is the standard CDSMP which has been implemented in community settings.<br>* Other names: CDSMP;|
| No Intervention: control<br>Group will receive no intervention for the first 6 months (pre / post), then be randomly assigned to one of the above interventions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index examining change at 6 and 12 months | Measure of obesity using height and weight | baseline, six months, one year | 
| blood pressure examining change at 6 and 12 months | diastolic and systolic measures | baseline, six months, one year | 
| Cholesterol levels examining change at 6 and 12 months | HDL, LDL, and total cholesterol levels | baseline, six months, one year | 
| blood glucose examining change at 6 and 12 months | blood glucose levels | baseline, six months, one year | 
| Cardiovascular risk scale examining change at 6 and 12 months | 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. | baseline, six months, one year | 
| Eating behaviors (Food propensity questionnaire) examining change at 6 and 12 months | Food propensity questionnaire used to estimate usual intake for food items and food groups. | baseline, six months, one year | 
| Physical activity (Measure of moderate-intensity physical activities) examining change at 6 and 12 months | Measure of moderate-intensity physical activities. | baseline, six months, one year | 
| Sedentary behavior (Measures total time spent sitting in transport, work and leisure) examining change at 6 and 12 months | Measures total time spent sitting in transport, work and leisure. | baseline, six months, one year | 
| Tobacco use examining change at 6 and 12 months | Measure of current and past tobacco use. | baseline, six months, one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months | Measure of communication with a physician. | baseline, six months, one year | 
| Self-assessed quality of life scale examining change at 6 and 12 months | CDC Healthy Days quality of life measure. | baseline, six months, one year | 
| Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 months | Personal Health Questionnaire Depression Scale (PHQ8). | baseline, six months, one year | 
| Prescription medication adherence examining change at 6 and 12 months | Measures medication compliance. | baseline, six months, one year | 
| Pain (Visual analogue scale) examining change at 6 and 12 months | Visual analogue scale to determine symptoms of chronic disease. | baseline, six months, one year | 
| Sleep (Visual analogue scale) examining change at 6 and 12 months | Visual analogue scale to determine symptoms of chronic disease. | baseline, six months, one year | 
| Stress (Visual analogue scale) examining change at 6 and 12 months | Visual analogue scale to determine symptoms of chronic disease. | baseline, six months, one year | 
| Fatigue (Visual analogue scale) examining change at 6 and 12 months | Visual analogue scale to determine symptoms of chronic disease. | baseline, six months, one year | 
| Well-being (SF-12) scale examining change at 6 and 12 months | Measure of functional health and well-being (SF-12). | baseline, six months, one year | 
| Quality of life (EQ-5D) scale examining change at 6 and 12 months | Measure of quality of life (EQ-5D). | baseline, six months, one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intervention, translation, workplace, CDSMP, CVD