Putting CDSMP to Work (WorkCDSMP)

University of Georgia (UGA)

Status: Completed

Conditions: Chronic Disease; Cardiovascular Diseases

Treatments: Behavioral: Workplace-tailored CDSMP; Behavioral: Chronic Disease Self-Management Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02409056

UGeorgia

Details and patient eligibility

About

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

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

800 participants in 3 patient groups

workplace-tailored CDSMP

Experimental group

Description:

Group will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace.

Treatment:

Behavioral: Workplace-tailored CDSMP

CDSMP usual care

Active Comparator group

Description:

Group will receive the standard CDSMP program which is currently being offered in a variety of community settings.

Treatment:

Behavioral: Chronic Disease Self-Management Program

control

No Intervention group

Description:

Group will receive no intervention for the first 6 months (pre / post), then be randomly assigned to one of the above interventions.