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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: Chronic Disease Self-Management Program (CDSMP); Behavioral: Financial Self-Management Program (FSMP)

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.

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Chronic Disease Self-Management Program (CDSMP); Other Names: Health Self-Management Program
Active Comparator: Financial Self-Management; Financial self-management course delivered in 3 modules, with a delivery time of approximately 1 hour per module.	Behavioral: Financial Self-Management Program (FSMP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Communication with Healthcare Provider Score 6M	3-item scale constructed by the CDSMP Stanford research team and used in the CDSMP National Evaluation (each item include 6-point Likert response scale (response range 0-5 per item)). Items reflect preparing list of questions to ask provider at visit, asking questions during the visit, discussing personal problems with provider during visits. Scores range from 0 to 15, with higher scores reflecting better communication.	6 months
Mean Communication with Healthcare Provider Score 12M	3-item scale constructed by the CDSMP Stanford research team and used in the CDSMP National Evaluation (each item include 6-point Likert response scale (response range 0-5 per item)). Items reflect preparing list of questions to ask provider at visit, asking questions during the visit, discussing personal problems with provider during visits. Scores range from 0 to 15, with higher scores reflecting better communication.	12 months
Medication adherence: Proportions and Means 6M	5 items internally constructed by research team members to reflect adherence over past month; proportions of participants in each group will be compared. Dichotomous items (No=0/Yes=1) include forgetting to take regularly scheduled medications, problems remembering to take regularly scheduled medication, stopping regularly scheduled medication when feeling better, stopping regularly scheduled medication when feeling worse. Participants responding they forgot to take regularly scheduled medication complete a 5th nominally-scaled item that asks how frequently they have forgotten to take in the past month (1 time =1, 2 times=2, 3 times=3, 4 times=4, 5 times=5, More than 5 times=6). Higher proportions on dichotomous items reflects worse within-group adherence. Higher mean scores on nominally-scaled item reflects worse within-group adherence.	6 months
Medication adherence Score: Proportions and Means 12M	5 items internally constructed by research team members to reflect adherence over past month; proportions of participants in each group will be compared. Dichotomous items (No=0/Yes=1) include forgetting to take regularly scheduled medications, problems remembering to take regularly scheduled medication, stopping regularly scheduled medication when feeling better, stopping regularly scheduled medication when feeling worse. Participants responding they forgot to take regularly scheduled medication complete a 5th nominally-scaled item that asks how frequently they have forgotten to take in the past month (1 time =1, 2 times=2, 3 times=3, 4 times=4, 5 times=5, More than 5 times=6). Higher proportions on dichotomous items reflects worse within-group adherence. Higher mean scores on nominally-scaled item reflects worse within-group adherence.	12 months
Mean Minutes per Week of Leisure Time Light or Moderate Exercise Score 6M	2 items that reflect the number of times per week engaged in light or moderate exercise during leisure time, and the number of minutes engaged in exercise for each occurrence; developed by CDSMP Stanford research team and used in CDSMP National Evaluation. Product of two items reflects total number of minutes per week, with possible ranges of 0 to 3360 (maximum score equivalent of 8 hours per day, 7 days per week). Higher scores = more favorable exercise profile.	6 months
Mean Minutes per Week of Leisure Time Light or Moderate Exercise Score 12M	2 items that reflect the number of times per week engaged in light or moderate exercise during leisure time, and the number of minutes engaged in exercise for each occurrence; developed by CDSMP Stanford research team and used in CDSMP National Evaluation. Product of two items reflects total number of minutes per week, with possible ranges of 0 to 3360 (maximum score equivalent of 8 hours per day, 7 days per week). Higher scores = more favorable exercise profile.	12 months
Mean Minutes per Week of Leisure Time Vigorous Exercise Score 6M	2 items that reflect the number of times per week engaged in vigorous exercise during leisure time, and the number of minutes engaged in exercise for each occurrence; developed by CDSMP Stanford research team and used in CDSMP National Evaluation. Product of two items reflects total number of minutes per week, with possible ranges of 0 to 3360 (maximum score equivalent of 8 hours per day, 7 days per week). Higher scores = more favorable exercise profile.	6 months
Mean Minutes per Week of Leisure Time Vigorous Exercise Score 12M	2 items that reflect the number of times per week engaged in vigorous exercise during leisure time, and the number of minutes engaged in exercise for each occurrence; developed by CDSMP Stanford research team and used in CDSMP National Evaluation. Product of two items reflects total number of minutes per week, with possible ranges of 0 to 3360 (maximum score equivalent of 8 hours per day, 7 days per week). Higher scores = more favorable exercise profile.	12 months
Mean Depressive Symptom Severity Score: Patient Health Questionnaire-8 6M	Valid and reliable instrument used in clinical settings to screen for possible depression. Includes 8 items, each with 4-point Likert responses that range from 0 to 3. Score range = 0 to 24, with higher scores reflecting more severe depressive symptoms.	6 months
Mean Depressive Symptom Severity Score: Patient Health Questionnaire-8 12M	Valid and reliable instrument used in clinical settings to screen for possible depression. Includes 8 items, each with 4-point Likert responses that range from 0 to 3. Score range = 0 to 24, with higher scores reflecting more severe depressive symptoms.	12 months
Mean Somatic Symptom Severity Score: Patient Health Questionnaire-15 6M	Valid and reliable instrument used in clinical settings to screen for somatization disorders. Includes 15 items, each with 3-point Likert responses that range from 0 to 2. Score range = 0 to 30, with higher scores reflecting more severe somatic symptoms.	6 months
Mean Somatic Symptom Severity Score: Patient Health Questionnaire-15 12M	Valid and reliable instrument used in clinical settings to screen for somatization disorders. Includes 15 items, each with 3-point Likert responses that range from 0 to 2. Score range = 0 to 30, with higher scores reflecting more severe somatic symptoms.	12 months
Mean Self-Rated Global Health Score: U.S. National Health Survey 6M	Single item of self-rated health with 5-point Likert response scale of 1 to 5. Higher score reflects poorer health rating.	6 months
Mean Self-Rated Global Health Score: U.S. National Health Survey 12M	Single item of self-rated health with 5-point Likert response scale of 1 to 5. Higher score reflects poorer health rating.	12 months
Mean Healthy Mental Health Days Score: Centers for Disease Control and Prevention 6M	Single item from BRFSS asking how many days out of past month mental health was not good. Possible range 0-31, with higher score reflecting worse mental health in past month.	6 months
Mean Healthy Mental Health Days Score: Centers for Disease Control and Prevention 12M	Single item from BRFSS asking how many days out of past month mental health was not good. Possible range 0-31, with higher score reflecting worse mental health in past month.	12 months
Mean Physical Health Days Score: Centers for Disease Control and Prevention 6M	Single item from BRFSS asking how many days out of past month physical health was not good. Possible range 0-31, with higher score reflecting worse mental health in past month.	6 months
Mean Physical Health Days Score: Centers for Disease Control and Prevention 12M	Single item from BRFSS asking how many days out of past month physical health was not good. Possible range 0-31, with higher score reflecting worse mental health in past month.	12 months
Mean Social Role Activity Limitation Score 6M	A 4-item scale developed by CDSMP research team at Stanford and used in CDSMP National Evaluation; each item with 5-point Likert response with item scores ranging from 0 to 4. Items reflect extent to which activities in the following social roles were limited due to health: activities with family / friends / neighbors / groups; hobbies or recreational activities; household chores; errands and shopping. Possible range of 0 to 16. Higher scores reflect more significant activity limitations due to health.	6 months
Mean Social Role Activity Limitation Score 12M	A 4-item scale developed by CDSMP research team at Stanford and used in CDSMP National Evaluation; each item with 5-point Likert response with item scores ranging from 0 to 4. Items reflect extent to which activities in the following social roles were limited due to health: activities with family / friends / neighbors / groups; hobbies or recreational activities; household chores; errands and shopping. Possible range of 0 to 16. Higher scores reflect more significant activity limitations due to health.	12 months
Mean Number of Times Hospitalized 6M	Single self-report item asking number of times hospitalized in past 3 months. Possible range 0 to 90. Higher score reflects greater hospitalization episodes.	6 months
Mean Number of Times Hospitalized 12M	Single self-report item asking number of times hospitalized in past 3 months. Possible range 0 to 90. Higher score reflects greater hospitalization episodes.	12 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Shawn M Kneipp, PhD, UNC-Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2015
• Primary Completion (Actual): September 26, 2018
• Study Completion (Actual): September 26, 2018

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: self-management; chronic disease; lower-wage workers
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 15-0962; 1U48DP005017-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: UNC will prepare de-identified limited-access dataset suitable for sharing with other researchers. De-identification will include removal of obvious identifiers such as names and addresses. It will also include examination of less obvious potentially identifying variables. Continuous variables with extreme values may have the extremes truncated. Height and weight are examples of such variables. Categorical variables with small numbers of participants in some categories may have these categories pooled with larger categories.
• IPD Sharing Time Frame: Data will be available on December 31, 2019
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No