Putting CDSMP to Work

Cardiovascular Diseases Clinical Trial

— WorkCDSMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409056
• Other study ID #: UGeorgia
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 28, 2020

Study information

• Verified date: June 2020
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 28, 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Disease

Intervention

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.
• Chronic Disease Self-Management Program
This is the standard CDSMP which has been implemented in community settings.

Locations

Country	Name	City	State
United States	Madison County Schools	Danielsville	Georgia
United States	City of Moultrie	Moultrie	Georgia
United States	Colquitt County Government	Moultrie	Georgia
United States	Colquitt County Schools	Moultrie	Georgia
United States	Colquitt Regional Medical Center	Moultrie	Georgia
United States	National Beef	Moultrie	Georgia
United States	Southwest Georgia Bank	Moultrie	Georgia
United States	Southwest Georgia Community Action Council	Moultrie	Georgia
United States	Southwest Regional Technical College	Moultrie	Georgia
United States	Turning Point Hospital	Moultrie	Georgia
United States	Lowndes County	Valdosta	Georgia
United States	Valdosta City Schools	Valdosta	Georgia
United States	Wiregrass Technical College	Valdosta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	YMCA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Absenteeism scale examining change at 6 and 12 months	Measures absence, lateness, and performance.	baseline, six months, one year
Other	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
Other	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
Other	Job satisfaction question examining change at 6 and 12 months	Measures job satisfaction.	baseline, six months, one year
Other	Organizational commitment scale examining change at 6 and 12 months	Measures organizational commitment.	baseline, six months, one year
Other	Turnover intention question examining change at 6 and 12 months	Measures likelihood of leaving the organization.	baseline, six months, one year
Other	Job stress scale examining change at 6 and 12 months	Measures job-related stress.	baseline, six months, one year
Other	Fatigue (Work-related fatigue assessment scale.) examining change at 6 and 12 months	Work-related fatigue assessment scale.	baseline, six months, one year
Other	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
Primary	Body Mass Index examining change at 6 and 12 months	Measure of obesity using height and weight	baseline, six months, one year
Primary	blood pressure examining change at 6 and 12 months	diastolic and systolic measures	baseline, six months, one year
Primary	Cholesterol levels examining change at 6 and 12 months	HDL, LDL, and total cholesterol levels	baseline, six months, one year
Primary	blood glucose examining change at 6 and 12 months	blood glucose levels	baseline, six months, one year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Tobacco use examining change at 6 and 12 months	Measure of current and past tobacco use.	baseline, six months, one year
Secondary	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
Secondary	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
Secondary	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
Secondary	Prescription medication adherence examining change at 6 and 12 months	Measures medication compliance.	baseline, six months, one year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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