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

NCT04116463 | Completed

• 2 other identifiers: 15-09621U48DP005017-01
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Keywords

lower-wage workers; chronic disease; self-management

Outcome Measures

Primary Outcomes (4)

• Mean Work Limitations Questionnaire-25 Score 6M: Percent productivity loss due to presenteeism

  The Work Limitations Questionnaire (WLQ) is a patient self-rated scale designed to assess on the- job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5- point scale from "All of the Time" (score 5) to "None of the Time" (score 0), or "Does Not Apply to My Job". The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24.9%. Higher percent productivity loss reflects more severe work limitations.

  6 months

• Mean Work Limitations Questionnaire-25 Score 12M: Percent productivity loss due to presenteeism

  The Work Limitations Questionnaire (WLQ) is a patient self-rated scale designed to assess on the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5- point scale from "All of the Time" (score 5) to "None of the Time" (score 0), or "Does Not Apply to My Job". The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24.9%. Higher percent productivity loss reflects more severe work limitations.

  12 months

• Mean Work Limitations Questionnaire-4 Score 6M: Percent productivity loss due to absenteeism

  The percentage of productivity lost due to work absences is the ratio of total missed work hours to total usual work hours in a two-week time frame. Both the numerator (total missed work hours due to health problems or medical care) and the denominator (total usual work hours) are computed based on information from four survey questions (two required and two optional), which are included in the WLQ Work Absence Module. Productivity loss due to absenteeism can range from 0% to 100%, with higher percent loss meaning more absenteeism.

  6 months

• Mean Work Limitations Questionnaire-4 Score 12M: Percent productivity loss due to absenteeism

  The percentage of productivity lost due to work absences is the ratio of total missed work hours to total usual work hours in a two-week time frame. Both the numerator (total missed work hours due to health problems or medical care) and the denominator (total usual work hours) are computed based on information from four survey questions (two required and two optional), which are included in the WLQ Work Absence Module. Productivity loss due to absenteeism can range from 0% to 100%, with higher percent loss meaning more absenteeism.

  12 months

Secondary Outcomes (22)

• Mean Communication with Healthcare Provider Score 6M

  6 months

• Mean Communication with Healthcare Provider Score 12M

  12 months

• Medication adherence: Proportions and Means 6M

  6 months

• Medication adherence Score: Proportions and Means 12M

  12 months

• Mean Minutes per Week of Leisure Time Light or Moderate Exercise Score 6M

  6 months

Study Arms (2)

CDSMP

EXPERIMENTAL

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.

Behavioral: Chronic Disease Self-Management Program (CDSMP)

Financial Self-Management

ACTIVE COMPARATOR

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

Behavioral: Financial Self-Management Program (FSMP)

Interventions

Chronic Disease Self-Management Program (CDSMP) BEHAVIORAL

Also known as: Health Self-Management Program

CDSMP

Financial Self-Management Program (FSMP) BEHAVIORAL

Financial Self-Management

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shawn M Kneipp, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized at the individual level into intervention or attention-control group.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 4, 2019
• Study Start: June 29, 2015
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available on December 31, 2019
• Access Criteria: The limited-access dataset will be made available on the date specified. Data will be released as micro data. A researcher wishing to use the dataset will be required to obtain approval from UNC using an agreement form which clearly specifies the intended analyses as well as assurances that UNC policies and HIPPA regulations will be followed. If approval is granted, the dataset will be supplied on a CD, or whatever the most appropriate medium is at the time the dataset is prepared. The CD will contain the dataset in the form of .csv files. It will also include documentation describing the variables in the dataset and copies of the data collection forms used to collect the data.

Locations

US (1)