Testing the Effects of the CDSMP Among Lower-to-Middle Wage Workers

NCT ID: NCT04116463

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-29
• Study Completion Date: 2018-09-26

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.

Conditions

Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CDSMP

Chronic Disease Self-Management Program (CDSMP) - a 6-week, group-based behavioral intervention delivered in a 2.5 hour session each week by a trained facilitator.

Group Type: EXPERIMENTAL

Chronic Disease Self-Management Program (CDSMP)

Intervention Type: BEHAVIORAL

Financial Self-Management

Financial self-management course delivered in 3 modules, with a delivery time of approximately 1 hour per module.

Group Type: ACTIVE_COMPARATOR

Financial Self-Management Program (FSMP)

Intervention Type: BEHAVIORAL

Interventions

Chronic Disease Self-Management Program (CDSMP)

Intervention Type: BEHAVIORAL

Financial Self-Management Program (FSMP)

Intervention Type: BEHAVIORAL

Other Intervention Names

Health Self-Management Program

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shawn M Kneipp, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

1U48DP005017-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-0962

Identifier Type: -

Identifier Source: org_study_id