Putting CDSMP to Work (WorkCDSMP)
Primary Purpose
Chronic Disease, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Workplace-tailored CDSMP
Chronic Disease Self-Management Program
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Disease focused on measuring intervention, translation, workplace, CVD, CDSMP
Eligibility Criteria
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
Sites / Locations
- Madison County Schools
- City of Moultrie
- Colquitt County Government
- Colquitt County Schools
- Colquitt Regional Medical Center
- National Beef
- Southwest Georgia Bank
- Southwest Georgia Community Action Council
- Southwest Regional Technical College
- Turning Point Hospital
- Lowndes County
- Valdosta City Schools
- Wiregrass Technical College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
workplace-tailored CDSMP
CDSMP usual care
control
Arm Description
Group will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace.
Group will receive the standard CDSMP program which is currently being offered in a variety of community settings.
Group will receive no intervention for the first 6 months (pre / post), then be randomly assigned to one of the above interventions.
Outcomes
Primary Outcome Measures
Body Mass Index examining change at 6 and 12 months
Measure of obesity using height and weight
blood pressure examining change at 6 and 12 months
diastolic and systolic measures
Cholesterol levels examining change at 6 and 12 months
HDL, LDL, and total cholesterol levels
blood glucose examining change at 6 and 12 months
blood glucose levels
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.
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.
Physical activity (Measure of moderate-intensity physical activities) examining change at 6 and 12 months
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
Measures total time spent sitting in transport, work and leisure.
Tobacco use examining change at 6 and 12 months
Measure of current and past tobacco use.
Secondary Outcome Measures
Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months
Measure of communication with a physician.
Self-assessed quality of life scale examining change at 6 and 12 months
CDC Healthy Days quality of life measure.
Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 months
Personal Health Questionnaire Depression Scale (PHQ8).
Prescription medication adherence examining change at 6 and 12 months
Measures medication compliance.
Pain (Visual analogue scale) examining change at 6 and 12 months
Visual analogue scale to determine symptoms of chronic disease.
Sleep (Visual analogue scale) examining change at 6 and 12 months
Visual analogue scale to determine symptoms of chronic disease.
Stress (Visual analogue scale) examining change at 6 and 12 months
Visual analogue scale to determine symptoms of chronic disease.
Fatigue (Visual analogue scale) examining change at 6 and 12 months
Visual analogue scale to determine symptoms of chronic disease.
Well-being (SF-12) scale examining change at 6 and 12 months
Measure of functional health and well-being (SF-12).
Quality of life (EQ-5D) scale examining change at 6 and 12 months
Measure of quality of life (EQ-5D).
Full Information
NCT ID
NCT02409056
First Posted
March 3, 2015
Last Updated
June 1, 2020
Sponsor
University of Georgia
Collaborators
YMCA
1. Study Identification
Unique Protocol Identification Number
NCT02409056
Brief Title
Putting CDSMP to Work
Acronym
WorkCDSMP
Official Title
Putting CDSMP to Work: Implementation of the Live Healthy, Work Healthy Program
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
YMCA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Cardiovascular Diseases
Keywords
intervention, translation, workplace, CVD, CDSMP
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
workplace-tailored CDSMP
Arm Type
Experimental
Arm Description
Group will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace.
Arm Title
CDSMP usual care
Arm Type
Active Comparator
Arm Description
Group will receive the standard CDSMP program which is currently being offered in a variety of community settings.
Arm Title
control
Arm Type
No Intervention
Arm Description
Group will receive no intervention for the first 6 months (pre / post), then be randomly assigned to one of the above interventions.
Intervention Type
Behavioral
Intervention Name(s)
Workplace-tailored CDSMP
Other Intervention Name(s)
Live Healthy Work Healthy Program
Intervention Description
This is the CDSMP program which has been modified to fit the unique characteristics of the workplace and will be offered in worksites.
Intervention Type
Behavioral
Intervention Name(s)
Chronic Disease Self-Management Program
Other Intervention Name(s)
CDSMP
Intervention Description
This is the standard CDSMP which has been implemented in community settings.
Primary Outcome Measure Information:
Title
Body Mass Index examining change at 6 and 12 months
Description
Measure of obesity using height and weight
Time Frame
baseline, six months, one year
Title
blood pressure examining change at 6 and 12 months
Description
diastolic and systolic measures
Time Frame
baseline, six months, one year
Title
Cholesterol levels examining change at 6 and 12 months
Description
HDL, LDL, and total cholesterol levels
Time Frame
baseline, six months, one year
Title
blood glucose examining change at 6 and 12 months
Description
blood glucose levels
Time Frame
baseline, six months, one year
Title
Cardiovascular risk scale examining change at 6 and 12 months
Description
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.
Time Frame
baseline, six months, one year
Title
Eating behaviors (Food propensity questionnaire) examining change at 6 and 12 months
Description
Food propensity questionnaire used to estimate usual intake for food items and food groups.
Time Frame
baseline, six months, one year
Title
Physical activity (Measure of moderate-intensity physical activities) examining change at 6 and 12 months
Description
Measure of moderate-intensity physical activities.
Time Frame
baseline, six months, one year
Title
Sedentary behavior (Measures total time spent sitting in transport, work and leisure) examining change at 6 and 12 months
Description
Measures total time spent sitting in transport, work and leisure.
Time Frame
baseline, six months, one year
Title
Tobacco use examining change at 6 and 12 months
Description
Measure of current and past tobacco use.
Time Frame
baseline, six months, one year
Secondary Outcome Measure Information:
Title
Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months
Description
Measure of communication with a physician.
Time Frame
baseline, six months, one year
Title
Self-assessed quality of life scale examining change at 6 and 12 months
Description
CDC Healthy Days quality of life measure.
Time Frame
baseline, six months, one year
Title
Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 months
Description
Personal Health Questionnaire Depression Scale (PHQ8).
Time Frame
baseline, six months, one year
Title
Prescription medication adherence examining change at 6 and 12 months
Description
Measures medication compliance.
Time Frame
baseline, six months, one year
Title
Pain (Visual analogue scale) examining change at 6 and 12 months
Description
Visual analogue scale to determine symptoms of chronic disease.
Time Frame
baseline, six months, one year
Title
Sleep (Visual analogue scale) examining change at 6 and 12 months
Description
Visual analogue scale to determine symptoms of chronic disease.
Time Frame
baseline, six months, one year
Title
Stress (Visual analogue scale) examining change at 6 and 12 months
Description
Visual analogue scale to determine symptoms of chronic disease.
Time Frame
baseline, six months, one year
Title
Fatigue (Visual analogue scale) examining change at 6 and 12 months
Description
Visual analogue scale to determine symptoms of chronic disease.
Time Frame
baseline, six months, one year
Title
Well-being (SF-12) scale examining change at 6 and 12 months
Description
Measure of functional health and well-being (SF-12).
Time Frame
baseline, six months, one year
Title
Quality of life (EQ-5D) scale examining change at 6 and 12 months
Description
Measure of quality of life (EQ-5D).
Time Frame
baseline, six months, one year
Other Pre-specified Outcome Measures:
Title
Absenteeism scale examining change at 6 and 12 months
Description
Measures absence, lateness, and performance.
Time Frame
baseline, six months, one year
Title
Presenteeism (Work Limitations Questionnaire (WLQ) examining change at 6 and 12 months
Description
Work Limitations Questionnaire (WLQ) assess the degree to which health problems interfered with job activities.
Time Frame
baseline, six months, one year
Title
Work ability index examining change at 6 and 12 months
Description
Assess physical and mental demands of work and worker's health status and resources.
Time Frame
baseline, six months, one year
Title
Job satisfaction question examining change at 6 and 12 months
Description
Measures job satisfaction.
Time Frame
baseline, six months, one year
Title
Organizational commitment scale examining change at 6 and 12 months
Description
Measures organizational commitment.
Time Frame
baseline, six months, one year
Title
Turnover intention question examining change at 6 and 12 months
Description
Measures likelihood of leaving the organization.
Time Frame
baseline, six months, one year
Title
Job stress scale examining change at 6 and 12 months
Description
Measures job-related stress.
Time Frame
baseline, six months, one year
Title
Fatigue (Work-related fatigue assessment scale.) examining change at 6 and 12 months
Description
Work-related fatigue assessment scale.
Time Frame
baseline, six months, one year
Title
Healthcare utilization (Self-report measures) examining change at 6 and 12 months
Description
Self-report measures of physician and hospital services.
Time Frame
baseline, six months, one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark G Wilson, HSD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew L Smith, PhD
Organizational Affiliation
Texas A&M University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Madison County Schools
City
Danielsville
State/Province
Georgia
ZIP/Postal Code
30633
Country
United States
Facility Name
City of Moultrie
City
Moultrie
State/Province
Georgia
ZIP/Postal Code
31768
Country
United States
Facility Name
Colquitt County Government
City
Moultrie
State/Province
Georgia
ZIP/Postal Code
31768
Country
United States
Facility Name
Colquitt County Schools
City
Moultrie
State/Province
Georgia
ZIP/Postal Code
31768
Country
United States
Facility Name
Colquitt Regional Medical Center
City
Moultrie
State/Province
Georgia
ZIP/Postal Code
31768
Country
United States
Facility Name
National Beef
City
Moultrie
State/Province
Georgia
ZIP/Postal Code
31768
Country
United States
Facility Name
Southwest Georgia Bank
City
Moultrie
State/Province
Georgia
ZIP/Postal Code
31768
Country
United States
Facility Name
Southwest Georgia Community Action Council
City
Moultrie
State/Province
Georgia
ZIP/Postal Code
31768
Country
United States
Facility Name
Southwest Regional Technical College
City
Moultrie
State/Province
Georgia
ZIP/Postal Code
31768
Country
United States
Facility Name
Turning Point Hospital
City
Moultrie
State/Province
Georgia
ZIP/Postal Code
31768
Country
United States
Facility Name
Lowndes County
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31602
Country
United States
Facility Name
Valdosta City Schools
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31602
Country
United States
Facility Name
Wiregrass Technical College
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31602
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Putting CDSMP to Work
We'll reach out to this number within 24 hrs