Chronic DiseaseWorkCDSMPNCT02409056
Putting CDSMP to Work
A study testing Workplace-tailored CDSMP and Chronic Disease Self-Management Program in people with Chronic Disease and Cardiovascular Diseases, run by University of Georgia at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Cardiovascular Diseases
- What is being tested?
- Workplace-tailored CDSMP and Chronic Disease Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 13 sitesUnited States
- Study dates
- Nov 2015to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Madison County Schools
Danielsville, Georgia, 30633
City of Moultrie
Moultrie, Georgia, 31768
Colquitt County Government
Moultrie, Georgia, 31768
Colquitt County Schools
Moultrie, Georgia, 31768
Colquitt Regional Medical Center
Moultrie, Georgia, 31768
National Beef
Moultrie, Georgia, 31768
Southwest Georgia Bank
Moultrie, Georgia, 31768
Southwest Georgia Community Action Council
Moultrie, Georgia, 31768
Southwest Regional Technical College
Moultrie, Georgia, 31768
Turning Point Hospital
Moultrie, Georgia, 31768
Lowndes County
Valdosta, Georgia, 31602
Valdosta City Schools
Valdosta, Georgia, 31602
Wiregrass Technical College
Valdosta, Georgia, 31602
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Disease, Cardiovascular Diseases
- Being tested
- Workplace-tailored CDSMP, Chronic Disease Self-Management Program
- Keywords
- intervention, translation, workplace, CVD, CDSMP
- Medical subject headings
- Chronic Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workplace-tailored CDSMPBehavioural
Also called Live Healthy Work Healthy Program
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 ProgramBehavioural
Also called CDSMP
This is the standard CDSMP which has been implemented in community settings.
| Study group | Role | What they receive |
|---|---|---|
| workplace-tailored CDSMP | Experimental | Group will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace. Receives: Behavioral: Workplace-tailored CDSMP |
| CDSMP usual care | Active comparator | Group will receive the standard CDSMP program which is currently being offered in a variety of community settings. Receives: Behavioral: Chronic Disease Self-Management Program |
| control | No intervention | Group will receive no intervention for the first 6 months (pre / post), then be randomly assigned to one of the above interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index examining change at 6 and 12 months
Measure of obesity using height and weight
Measured: baseline, six months, one year
blood pressure examining change at 6 and 12 months
diastolic and systolic measures
Measured: baseline, six months, one year
Cholesterol levels examining change at 6 and 12 months
HDL, LDL, and total cholesterol levels
Measured: baseline, six months, one year
blood glucose examining change at 6 and 12 months
blood glucose levels
Measured: baseline, six months, one year
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.
Measured: baseline, six months, one year
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.
Measured: baseline, six months, one year
Physical activity (Measure of moderate-intensity physical activities) examining change at 6 and 12 months
Measure of moderate-intensity physical activities.
Measured: baseline, six months, one year
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.
Measured: baseline, six months, one year
Tobacco use examining change at 6 and 12 months
Measure of current and past tobacco use.
Measured: baseline, six months, one year
Secondary outcomes (10)
Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months
Measure of communication with a physician.
Measured: baseline, six months, one year
Self-assessed quality of life scale examining change at 6 and 12 months
CDC Healthy Days quality of life measure.
Measured: baseline, six months, one year
Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 months
Personal Health Questionnaire Depression Scale (PHQ8).
Measured: baseline, six months, one year
Prescription medication adherence examining change at 6 and 12 months
Measures medication compliance.
Measured: baseline, six months, one year
Pain (Visual analogue scale) examining change at 6 and 12 months
Visual analogue scale to determine symptoms of chronic disease.
Measured: baseline, six months, one year
Sleep (Visual analogue scale) examining change at 6 and 12 months
Visual analogue scale to determine symptoms of chronic disease.
Measured: baseline, six months, one year
Stress (Visual analogue scale) examining change at 6 and 12 months
Visual analogue scale to determine symptoms of chronic disease.
Measured: baseline, six months, one year
Fatigue (Visual analogue scale) examining change at 6 and 12 months
Visual analogue scale to determine symptoms of chronic disease.
Measured: baseline, six months, one year
Well-being (SF-12) scale examining change at 6 and 12 months
Measure of functional health and well-being (SF-12).
Measured: baseline, six months, one year
Quality of life (EQ-5D) scale examining change at 6 and 12 months
Measure of quality of life (EQ-5D).
Measured: baseline, six months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- YMCA
- Responsible party
- Principal investigator, Mark Wilson, University of Georgia
- Investigators
- Mark G Wilson, HSD, Principal investigator, University of GeorgiaMatthew L Smith, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409056
- Sponsor's protocol ID
- UGeorgia
- Acronym
- WorkCDSMP
- Status last verified
- Jun 2020
- First submitted
- 3 Mar 2015
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Putting CDSMP to Work: Implementation of the Live Healthy, Work Healthy Program
- ClinicalTrials.gov ID
- NCT02409056
- Acronym / sponsor ID
- WorkCDSMP / UGeorgia
- Conditions
- Chronic Disease, Cardiovascular Diseases
- Keywords
- intervention, translation, workplace, CVD, CDSMP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- YMCA
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| workplace-tailored CDSMP | Experimental | Behavioral: Workplace-tailored CDSMPGroup will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace. |
| CDSMP usual care | Active comparator | Behavioral: Chronic Disease Self-Management ProgramGroup will receive the standard CDSMP program which is currently being offered in a variety of community settings. |
| control | No intervention | –Group will receive no intervention for the first 6 months (pre / post), then be randomly assigned to one of the above interventions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workplace-tailored CDSMPAlso: Live Healthy Work Healthy ProgramThis is the CDSMP program which has been modified to fit the unique characteristics of the workplace and will be offered in worksites. | Behavioural | workplace-tailored CDSMP |
| Chronic Disease Self-Management ProgramAlso: CDSMPThis is the standard CDSMP which has been implemented in community settings. | Behavioural | CDSMP usual care |
Primary outcome
Body Mass Index examining change at 6 and 12 months
Time frame: baseline, six months, one year
Measure of obesity using height and weight
blood pressure examining change at 6 and 12 months
Time frame: baseline, six months, one year
diastolic and systolic measures
Cholesterol levels examining change at 6 and 12 months
Time frame: baseline, six months, one year
HDL, LDL, and total cholesterol levels
blood glucose examining change at 6 and 12 months
Time frame: baseline, six months, one year
blood glucose levels
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.
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.
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.
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.
Tobacco use examining change at 6 and 12 months
Time frame: baseline, six months, one year
Measure of current and past tobacco use.
10 secondary outcomes
Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months
Time frame: 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
Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 months
Time frame: baseline, six months, one year
Prescription medication adherence examining change at 6 and 12 months
Time frame: baseline, six months, one year
Pain (Visual analogue scale) examining change at 6 and 12 months
Time frame: baseline, six months, one year
Sleep (Visual analogue scale) examining change at 6 and 12 months
Time frame: baseline, six months, one year
Stress (Visual analogue scale) examining change at 6 and 12 months
Time frame: baseline, six months, one year
Fatigue (Visual analogue scale) examining change at 6 and 12 months
Time frame: baseline, six months, one year
Well-being (SF-12) scale examining change at 6 and 12 months
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark G Wilson, HSD principal investigator
University of Georgia
Matthew L Smith, PhD principal investigator
Texas A&M University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workplace-tailored CDSMP and Chronic Disease Self-Management Program in people with Chronic Disease and Cardiovascular Diseases, run by University of Georgia at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index examining change at 6 and 12 months (time frame: baseline, six months, one year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.