Clinical trial NCT04116463: Testing the Effects of the CDSMP Among Lower-to-Middle Wage Workers
Official title: Testing the Effects of the CDSMP Among Lower-to-Middle Wage Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: lower-wage workers
chronic disease
self-management
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2019-10-04
Enrollment: 327
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized at the individual level into intervention or attention-control group.
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed research is to extend the CDSMP to lower-wage populations aged 40-64 years by partnering with public libraries and employment support networks in select North Carolina counties. The specific aims of this research are to (1) test the effects of the CDSMP on employment and health outcomes among lower-wage working adults 40-64 years of age at 6 and 12 months from baseline, and explore the extent to which they are modified by select sociodemographic, chronic condition, and work-related factors, (2) conduct an economic evaluation of the CDSMP for employers (return on investment \[ROI\]), the health care system (ROI), and state governments (cost-effectiveness analysis (CEA)), and (3) assess factors associated with the reach, effectiveness, adoption, and implementation of the CDSMP among lower-wage workers using social marketing strategies designed to overcome program engagement and participation challenges that exist in this population.

Detailed description: To evaluate the CDSMP's effect on key employment outcomes, an experienced team from the UNC-CH Prevention Research Center (PRC) will leverage its long-standing partnerships with employer networks, public libraries and community agencies throughout the state and the NC Division of Aging's network of 500 active CDSMP interventionists to conduct the proposed work. This research will produce new knowledge about CDSMP effects by (1) testing it in a high chronic disease burden population of employed, lower-wage adults in their preretirement years (ages 40-64), (2) focusing on employment productivity and cost-specific outcomes that would have direct relevance for employers, insurers, and policy-makers, and (3) targeting recruitment and CDSMP delivery to enhance uptake by lower-wage workers. The specific aims of the proposed study are to:

1. Test the effects of the CDSMP on employment and health outcomes among lower-wage working adults 40-64 years of age at 6 and 12 months from baseline, and explore the extent to which they are modified by select sociodemographic, chronic condition, and work-related factors. The primary study outcome is work productivity, measured as lost productivity time using Health and Work Performance Questionnaire (HPQ) absenteeism and presenteeism scores. Secondary study outcomes reflect health dimensions that are typically evaluated in relation to CDSMP delivery, and include measures of: chronic disease management self-efficacy, self management behaviors, health status, and healthcare utilization.
2. Conduct an economic evaluation of the CDSMP for employers (return on investment \[ROI\]), the health care system (ROI), and state governments (cost-effectiveness analysis \[CEA\]).
3. Assess factors associated with the reach, effectiveness, adoption, and implementation of the CDSMP among lower-wage workers using social marketing strategies designed to overcome program engagement and participation challenges that exist in this population.

Eligibility criteria: Inclusion Criteria:

* 40-64 years of age,
* residing within one of the 3 study counties,
* being employed 32 hours or more per week,
* being able to speak, read, and write in English,
* earning less than $60,000/year, and
* self-reporting having been diagnosed with at least one of the following chronic diseases: arthritis (osteoarthritis, rheumatoid, or gout); diabetes (Type I or II); cardiovascular disease; stroke; lung disease; chronic musculoskeletal-related pain; recurrent tension, migraine, or chronic daily headaches; HIV; Crohn's disease; depression; anxiety or panic attacks; post-traumatic stress disorder; or bipolar disorder.

Exclusion Criteria:

* unable to follow study instructions,
* severely disruptive, offensive, or socially inappropriate during group CDSMP workshops, or
* experiences an illness or injury during the study period that results in severe cognitive impairment.

Primary outcomes:
measure: Mean Work Limitations Questionnaire-25 Score 6M: Percent productivity loss due to presenteeism
timeFrame: 6 months
measure: Mean Work Limitations Questionnaire-25 Score 12M: Percent productivity loss due to presenteeism
timeFrame: 12 months
measure: Mean Work Limitations Questionnaire-4 Score 6M: Percent productivity loss due to absenteeism
timeFrame: 6 months
measure: Mean Work Limitations Questionnaire-4 Score 12M: Percent productivity loss due to absenteeism
timeFrame: 12 months
Secondary outcomes:
measure: Mean Communication with Healthcare Provider Score 6M
timeFrame: 6 months
measure: Mean Communication with Healthcare Provider Score 12M
timeFrame: 12 months
measure: Medication adherence: Proportions and Means 6M
timeFrame: 6 months
measure: Medication adherence Score: Proportions and Means 12M
timeFrame: 12 months
measure: Mean Minutes per Week of Leisure Time Light or Moderate Exercise Score 6M
timeFrame: 6 months
measure: Mean Minutes per Week of Leisure Time Light or Moderate Exercise Score 12M
timeFrame: 12 months
measure: Mean Minutes per Week of Leisure Time Vigorous Exercise Score 6M
timeFrame: 6 months
measure: Mean Minutes per Week of Leisure Time Vigorous Exercise Score 12M
timeFrame: 12 months
measure: Mean Depressive Symptom Severity Score: Patient Health Questionnaire-8 6M
timeFrame: 6 months
measure: Mean Depressive Symptom Severity Score: Patient Health Questionnaire-8 12M
timeFrame: 12 months
measure: Mean Somatic Symptom Severity Score: Patient Health Questionnaire-15 6M
timeFrame: 6 months
measure: Mean Somatic Symptom Severity Score: Patient Health Questionnaire-15 12M
timeFrame: 12 months
measure: Mean Self-Rated Global Health Score: U.S. National Health Survey 6M
timeFrame: 6 months
measure: Mean Self-Rated Global Health Score: U.S. National Health Survey 12M
timeFrame: 12 months
measure: Mean Healthy Mental Health Days Score: Centers for Disease Control and Prevention 6M
timeFrame: 6 months
measure: Mean Healthy Mental Health Days Score: Centers for Disease Control and Prevention 12M
timeFrame: 12 months
measure: Mean Physical Health Days Score: Centers for Disease Control and Prevention 6M
timeFrame: 6 months
measure: Mean Physical Health Days Score: Centers for Disease Control and Prevention 12M
timeFrame: 12 months
measure: Mean Social Role Activity Limitation Score 6M
timeFrame: 6 months
measure: Mean Social Role Activity Limitation Score 12M
timeFrame: 12 months
measure: Mean Number of Times Hospitalized 6M
timeFrame: 6 months
measure: Mean Number of Times Hospitalized 12M
timeFrame: 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Shawn M Kneipp, PhD
role: PRINCIPAL_INVESTIGATOR
References: