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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

800

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach

1 country

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

March 3, 2015

Completed

1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2015

Completed

7 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed

Last Updated

June 2, 2020

Status Verified

June 1, 2020

Enrollment Period

4 years

First QC Date

March 3, 2015

Last Update Submit

June 1, 2020

Conditions

Chronic Disease Cardiovascular Diseases

Keywords

interventiontranslationworkplaceCVDCDSMP

Outcome Measures

Primary Outcomes (9)

Body Mass Index examining change at 6 and 12 months
Measure of obesity using height and weight
baseline, six months, one year
blood pressure examining change at 6 and 12 months
diastolic and systolic measures
baseline, six months, one year
Cholesterol levels examining change at 6 and 12 months
HDL, LDL, and total cholesterol levels
baseline, six months, one year
blood glucose examining change at 6 and 12 months
blood glucose levels
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.
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.
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.
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.
baseline, six months, one year
Tobacco use examining change at 6 and 12 months
Measure of current and past tobacco use.
baseline, six months, one year

Secondary Outcomes (10)

Patient-provider communication (Measure of communication with a physician) examining change at 6 and 12 months
baseline, six months, one year
Self-assessed quality of life scale examining change at 6 and 12 months
baseline, six months, one year
Depression (Personal Health Questionnaire Depression Scale (PHQ8) examining change at 6 and 12 months
baseline, six months, one year
Prescription medication adherence examining change at 6 and 12 months
baseline, six months, one year
Pain (Visual analogue scale) examining change at 6 and 12 months
baseline, six months, one year
+5 more secondary outcomes

Other Outcomes (9)

Absenteeism scale examining change at 6 and 12 months
baseline, six months, one year
Presenteeism (Work Limitations Questionnaire (WLQ) examining change at 6 and 12 months
baseline, six months, one year
Work ability index examining change at 6 and 12 months
baseline, six months, one year
+6 more other outcomes

Study Arms (3)

workplace-tailored CDSMP

EXPERIMENTAL

Group will receive the CDSMP program which has been modified to fit the unique characteristics of the workplace.

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.

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.

Interventions

Workplace-tailored CDSMPBEHAVIORAL

This is the CDSMP program which has been modified to fit the unique characteristics of the workplace and will be offered in worksites.

Also known as: Live Healthy Work Healthy Program

workplace-tailored CDSMP

Chronic Disease Self-Management ProgramBEHAVIORAL

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

Also known as: CDSMP

CDSMP usual care

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Georgialead
YMCAcollaborator

Study Sites (13)

Madison County Schools

Danielsville, Georgia, 30633, United States

Location

City of Moultrie