Clinical trial NCT02409056: Putting CDSMP to Work
Official title: Putting CDSMP to Work: Implementation of the Live Healthy, Work Healthy Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Cardiovascular Diseases
Keywords: intervention
translation
workplace
CVD
CDSMP
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: YMCA
First posted: 2015-04-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: blood pressure examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Cholesterol levels examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: blood glucose examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Cardiovascular risk scale examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Eating behaviors (Food propensity questionnaire) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Physical activity (Measure of moderate-intensity physical activities) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Sedentary behavior (Measures total time spent sitting in transport, work and leisure) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Tobacco use examining change at 6 and 12 months
timeFrame: baseline, six months, one year
Secondary outcomes:
measure: Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Self-assessed quality of life scale examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Prescription medication adherence examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Pain (Visual analogue scale) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Sleep (Visual analogue scale) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Stress (Visual analogue scale) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Fatigue (Visual analogue scale) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Well-being (SF-12) scale examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Quality of life (EQ-5D) scale examining change at 6 and 12 months
timeFrame: baseline, six months, one year
Other outcomes:
measure: Absenteeism scale examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Presenteeism (Work Limitations Questionnaire (WLQ) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Work ability index examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Job satisfaction question examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Organizational commitment scale examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Turnover intention question examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Job stress scale examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Fatigue (Work-related fatigue assessment scale.) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
measure: Healthcare utilization (Self-report measures) examining change at 6 and 12 months
timeFrame: baseline, six months, one year
Locations:
city: Danielsville
country: United States
facility: Madison County Schools
state: Georgia
city: Moultrie
country: United States
facility: City of Moultrie
state: Georgia
city: Moultrie
country: United States
facility: Colquitt County Government
state: Georgia
city: Moultrie
country: United States
facility: Colquitt County Schools
state: Georgia
city: Moultrie
country: United States
facility: Colquitt Regional Medical Center
state: Georgia
city: Moultrie
country: United States
facility: National Beef
state: Georgia
city: Moultrie
country: United States
facility: Southwest Georgia Bank
state: Georgia
city: Moultrie
country: United States
facility: Southwest Georgia Community Action Council
state: Georgia
city: Moultrie
country: United States
facility: Southwest Regional Technical College
state: Georgia
city: Moultrie
country: United States
facility: Turning Point Hospital
state: Georgia
city: Valdosta
country: United States
facility: Lowndes County
state: Georgia
city: Valdosta
country: United States
facility: Valdosta City Schools
state: Georgia
city: Valdosta
country: United States
facility: Wiregrass Technical College
state: Georgia
Study officials:
affiliation: University of Georgia
name: Mark G Wilson, HSD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas A&M University
name: Matthew L Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: