Putting CDSMP to Work (WorkCDSMP)

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

This project is the test of the effectiveness of the Chronic Disease Self-Management Program which will be translated to a worksite setting.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Chronic Disease
• Intervention / Treatment: Behavioral: Workplace-tailored CDSMP; Behavioral: Chronic Disease Self-Management Program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Danielsville, Georgia, United States, 30633
      • Madison County Schools
    • Moultrie, Georgia, United States, 31768
      • City of Moultrie
    • Moultrie, Georgia, United States, 31768
      • Colquitt County Government
    • Moultrie, Georgia, United States, 31768
      • Colquitt County Schools
    • Moultrie, Georgia, United States, 31768
      • Colquitt Regional Medical Center
    • Moultrie, Georgia, United States, 31768
      • National Beef
    • Moultrie, Georgia, United States, 31768
      • Southwest Georgia Bank
    • Moultrie, Georgia, United States, 31768
      • Southwest Georgia Community Action Council
    • Moultrie, Georgia, United States, 31768
      • Southwest Regional Technical College
    • Moultrie, Georgia, United States, 31768
      • Turning Point Hospital
    • Valdosta, Georgia, United States, 31602
      • Lowndes County
    • Valdosta, Georgia, United States, 31602
      • Valdosta City Schools
    • Valdosta, Georgia, United States, 31602
      • Wiregrass Technical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: workplace-tailored CDSMP; Group will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace.	Behavioral: Workplace-tailored CDSMP; This is the CDSMP program which has been modified to fit the unique characteristics of the workplace and will be offered in worksites.; Other Names: Live Healthy Work Healthy Program
Active Comparator: CDSMP usual care; Group will receive the standard CDSMP program which is currently being offered in a variety of community settings.	Behavioral: Chronic Disease Self-Management Program; This is the standard CDSMP which has been implemented in community settings.; Other Names: CDSMP
No Intervention: control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absenteeism scale examining change at 6 and 12 months	Measures absence, lateness, and performance.	baseline, six months, one year
Presenteeism (Work Limitations Questionnaire (WLQ) examining change at 6 and 12 months	Work Limitations Questionnaire (WLQ) assess the degree to which health problems interfered with job activities.	baseline, six months, one year
Work ability index examining change at 6 and 12 months	Assess physical and mental demands of work and worker's health status and resources.	baseline, six months, one year
Job satisfaction question examining change at 6 and 12 months	Measures job satisfaction.	baseline, six months, one year
Organizational commitment scale examining change at 6 and 12 months	Measures organizational commitment.	baseline, six months, one year
Turnover intention question examining change at 6 and 12 months	Measures likelihood of leaving the organization.	baseline, six months, one year
Job stress scale examining change at 6 and 12 months	Measures job-related stress.	baseline, six months, one year
Fatigue (Work-related fatigue assessment scale.) examining change at 6 and 12 months	Work-related fatigue assessment scale.	baseline, six months, one year
Healthcare utilization (Self-report measures) examining change at 6 and 12 months	Self-report measures of physician and hospital services.	baseline, six months, one year

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: YMCA
• Investigators: Principal Investigator: Mark G Wilson, HSD, University of Georgia; Principal Investigator: Matthew L Smith, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: March 3, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimate): April 6, 2015

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: intervention; CVD; workplace; translation; CDSMP
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Cardiovascular Diseases; Chronic Disease
• Other Study ID Numbers: UGeorgia