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Putting CDSMP to Work

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02409056
Acronym
WorkCDSMP
Enrollment
800
Registered
2015-04-06
Start date
2015-11-30
Completion date
2020-02-28
Last updated
2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Chronic Disease

Keywords

intervention, translation, workplace, CVD, CDSMP

Brief summary

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.

Interventions

BEHAVIORALWorkplace-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.

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

Sponsors

YMCA
CollaboratorOTHER
University of Georgia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sedentary behavior (Measures total time spent sitting in transport, work and leisure) examining change at 6 and 12 monthsbaseline, six months, one yearMeasures total time spent sitting in transport, work and leisure.
Physical activity (Measure of moderate-intensity physical activities) examining change at 6 and 12 monthsbaseline, six months, one yearMeasure of moderate-intensity physical activities.
Eating behaviors (Food propensity questionnaire) examining change at 6 and 12 monthsbaseline, six months, one yearFood propensity questionnaire used to estimate usual intake for food items and food groups.
Cardiovascular risk scale examining change at 6 and 12 monthsbaseline, six months, one yearOverall 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.
Body Mass Index examining change at 6 and 12 monthsbaseline, six months, one yearMeasure of obesity using height and weight
blood glucose examining change at 6 and 12 monthsbaseline, six months, one yearblood glucose levels
Cholesterol levels examining change at 6 and 12 monthsbaseline, six months, one yearHDL, LDL, and total cholesterol levels
blood pressure examining change at 6 and 12 monthsbaseline, six months, one yeardiastolic and systolic measures
Tobacco use examining change at 6 and 12 monthsbaseline, six months, one yearMeasure of current and past tobacco use.

Secondary

MeasureTime frameDescription
Quality of life (EQ-5D) scale examining change at 6 and 12 monthsbaseline, six months, one yearMeasure of quality of life (EQ-5D).
Sleep (Visual analogue scale) examining change at 6 and 12 monthsbaseline, six months, one yearVisual analogue scale to determine symptoms of chronic disease.
Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 monthsbaseline, six months, one yearMeasure of communication with a physician.
Self-assessed quality of life scale examining change at 6 and 12 monthsbaseline, six months, one yearCDC Healthy Days quality of life measure.
Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 monthsbaseline, six months, one yearPersonal Health Questionnaire Depression Scale (PHQ8).
Prescription medication adherence examining change at 6 and 12 monthsbaseline, six months, one yearMeasures medication compliance.
Pain (Visual analogue scale) examining change at 6 and 12 monthsbaseline, six months, one yearVisual analogue scale to determine symptoms of chronic disease.
Stress (Visual analogue scale) examining change at 6 and 12 monthsbaseline, six months, one yearVisual analogue scale to determine symptoms of chronic disease.
Fatigue (Visual analogue scale) examining change at 6 and 12 monthsbaseline, six months, one yearVisual analogue scale to determine symptoms of chronic disease.
Well-being (SF-12) scale examining change at 6 and 12 monthsbaseline, six months, one yearMeasure of functional health and well-being (SF-12).

Other

MeasureTime frameDescription
Absenteeism scale examining change at 6 and 12 monthsbaseline, six months, one yearMeasures absence, lateness, and performance.
Healthcare utilization (Self-report measures) examining change at 6 and 12 monthsbaseline, six months, one yearSelf-report measures of physician and hospital services.
Fatigue (Work-related fatigue assessment scale.) examining change at 6 and 12 monthsbaseline, six months, one yearWork-related fatigue assessment scale.
Job stress scale examining change at 6 and 12 monthsbaseline, six months, one yearMeasures job-related stress.
Turnover intention question examining change at 6 and 12 monthsbaseline, six months, one yearMeasures likelihood of leaving the organization.
Organizational commitment scale examining change at 6 and 12 monthsbaseline, six months, one yearMeasures organizational commitment.
Job satisfaction question examining change at 6 and 12 monthsbaseline, six months, one yearMeasures job satisfaction.
Work ability index examining change at 6 and 12 monthsbaseline, six months, one yearAssess physical and mental demands of work and worker's health status and resources.
Presenteeism (Work Limitations Questionnaire (WLQ) examining change at 6 and 12 monthsbaseline, six months, one yearWork Limitations Questionnaire (WLQ) assess the degree to which health problems interfered with job activities.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026