Putting CDSMP to Work (WorkCDSMP)

June 1, 2020 updated by: Mark Wilson, University of Georgia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Mass Index examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Measure of obesity using height and weight
baseline, six months, one year
blood pressure examining change at 6 and 12 months
Time Frame: baseline, six months, one year
diastolic and systolic measures
baseline, six months, one year
Cholesterol levels examining change at 6 and 12 months
Time Frame: baseline, six months, one year
HDL, LDL, and total cholesterol levels
baseline, six months, one year
blood glucose examining change at 6 and 12 months
Time Frame: baseline, six months, one year
blood glucose levels
baseline, six months, one year
Cardiovascular risk scale examining change at 6 and 12 months
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
Measures total time spent sitting in transport, work and leisure.
baseline, six months, one year
Tobacco use examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Measure of current and past tobacco use.
baseline, six months, one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Measure of communication with a physician.
baseline, six months, one year
Self-assessed quality of life scale examining change at 6 and 12 months
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
Personal Health Questionnaire Depression Scale (PHQ8).
baseline, six months, one year
Prescription medication adherence examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Measures medication compliance.
baseline, six months, one year
Pain (Visual analogue scale) examining change at 6 and 12 months
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
Measure of quality of life (EQ-5D).
baseline, six months, one year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absenteeism scale examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Measures absence, lateness, and performance.
baseline, six months, one year
Presenteeism (Work Limitations Questionnaire (WLQ) examining change at 6 and 12 months
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
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
Time Frame: baseline, six months, one year
Measures job satisfaction.
baseline, six months, one year
Organizational commitment scale examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Measures organizational commitment.
baseline, six months, one year
Turnover intention question examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Measures likelihood of leaving the organization.
baseline, six months, one year
Job stress scale examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Measures job-related stress.
baseline, six months, one year
Fatigue (Work-related fatigue assessment scale.) examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Work-related fatigue assessment scale.
baseline, six months, one year
Healthcare utilization (Self-report measures) examining change at 6 and 12 months
Time Frame: baseline, six months, one year
Self-report measures of physician and hospital services.
baseline, six months, one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Georgia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
YMCA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark G Wilson, HSD, University of Georgia
  • Principal Investigator: Matthew L Smith, PhD, Texas A&M University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UGeorgia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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