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Completed

NCT Number: NCT02409056

Putting CDSMP to Work

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

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Key information

Conditions

Chronic Disease Cardiovascular Diseases Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Madison County Schools, Danielsville, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Workplace-tailored CDSMP

Behavioral

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

Chronic Disease Self-Management Program

Behavioral

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

Other names: CDSMP

Primary outcomes

  1. Body Mass Index examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    Measure of obesity using height and weight

  2. blood pressure examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    diastolic and systolic measures

  3. Cholesterol levels examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    HDL, LDL, and total cholesterol levels

  4. blood glucose examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    blood glucose levels

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Tobacco use examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    Measure of current and past tobacco use.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. Prescription medication adherence examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    Measures medication compliance.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

Other outcomes

  1. Absenteeism scale examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    Measures absence, lateness, and performance.

  2. 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.

  3. 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.

  4. Job satisfaction question examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    Measures job satisfaction.

  5. Organizational commitment scale examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    Measures organizational commitment.

  6. Turnover intention question examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    Measures likelihood of leaving the organization.

  7. Job stress scale examining change at 6 and 12 months

    Time frame: baseline, six months, one year

    Measures job-related stress.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • YMCA

Registry information

Official study title

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

Acronym: WorkCDSMP

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Apr 6, 2015
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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