Putting CDSMP to Work

NCT ID: NCT02409056

Last Updated: 2020-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-02-28

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.

Conditions

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Chronic Disease Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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workplace-tailored CDSMP

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

Group Type EXPERIMENTAL

Workplace-tailored CDSMP

Intervention Type BEHAVIORAL

This is the CDSMP program which has been modified to fit the unique characteristics of the workplace and will be offered in worksites.

CDSMP usual care

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

Group Type ACTIVE_COMPARATOR

Chronic Disease Self-Management Program

Intervention Type BEHAVIORAL

This is the standard CDSMP which has been implemented in community settings.

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Chronic Disease Self-Management Program

This is the standard CDSMP which has been implemented in community settings.

Intervention Type BEHAVIORAL

Other Intervention Names

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Live Healthy Work Healthy Program CDSMP

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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YMCA

OTHER

Sponsor Role collaborator

University of Georgia

OTHER

Sponsor Role lead

Responsible Party

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Mark Wilson

Associate Dean for Academic Affairs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark G Wilson, HSD

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Matthew L Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

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Madison County Schools

Danielsville, Georgia, United States

Site Status

City of Moultrie

Moultrie, Georgia, United States

Site Status

Colquitt County Government

Moultrie, Georgia, United States

Site Status

Colquitt County Schools

Moultrie, Georgia, United States

Site Status

Colquitt Regional Medical Center

Moultrie, Georgia, United States

Site Status

National Beef

Moultrie, Georgia, United States

Site Status

Southwest Georgia Bank

Moultrie, Georgia, United States

Site Status

Southwest Georgia Community Action Council

Moultrie, Georgia, United States

Site Status

Southwest Regional Technical College

Moultrie, Georgia, United States

Site Status

Turning Point Hospital

Moultrie, Georgia, United States

Site Status

Lowndes County

Valdosta, Georgia, United States

Site Status

Valdosta City Schools

Valdosta, Georgia, United States

Site Status

Wiregrass Technical College

Valdosta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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UGeorgia

Identifier Type: -

Identifier Source: org_study_id

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