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

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic Disease Self-Management Program (CDSMP)
Financial Self-Management Program (FSMP)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring lower-wage workers, chronic disease, self-management

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CDSMP

Financial Self-Management

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 3, 2019
Last Updated
October 3, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04116463
Brief Title
Testing the Effects of the CDSMP Among Lower-to-Middle Wage Workers
Acronym
SMARTLife
Official Title
Testing the Effects of the CDSMP Among Lower-to-Middle Wage Workers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 29, 2015 (Actual)
Primary Completion Date
September 26, 2018 (Actual)
Study Completion Date
September 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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]). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
lower-wage workers, chronic disease, self-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized at the individual level into intervention or attention-control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDSMP
Arm Type
Experimental
Arm Description
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.
Arm Title
Financial Self-Management
Arm Type
Active Comparator
Arm Description
Financial self-management course delivered in 3 modules, with a delivery time of approximately 1 hour per module.
Intervention Type
Behavioral
Intervention Name(s)
Chronic Disease Self-Management Program (CDSMP)
Other Intervention Name(s)
Health Self-Management Program
Intervention Type
Behavioral
Intervention Name(s)
Financial Self-Management Program (FSMP)
Primary Outcome Measure Information:
Title
Mean Work Limitations Questionnaire-25 Score 6M: Percent productivity loss due to presenteeism
Description
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.
Time Frame
6 months
Title
Mean Work Limitations Questionnaire-25 Score 12M: Percent productivity loss due to presenteeism
Description
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.
Time Frame
12 months
Title
Mean Work Limitations Questionnaire-4 Score 6M: Percent productivity loss due to absenteeism
Description
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.
Time Frame
6 months
Title
Mean Work Limitations Questionnaire-4 Score 12M: Percent productivity loss due to absenteeism
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean Communication with Healthcare Provider Score 6M
Description
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.
Time Frame
6 months
Title
Mean Communication with Healthcare Provider Score 12M
Description
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.
Time Frame
12 months
Title
Medication adherence: Proportions and Means 6M
Description
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.
Time Frame
6 months
Title
Medication adherence Score: Proportions and Means 12M
Description
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.
Time Frame
12 months
Title
Mean Minutes per Week of Leisure Time Light or Moderate Exercise Score 6M
Description
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.
Time Frame
6 months
Title
Mean Minutes per Week of Leisure Time Light or Moderate Exercise Score 12M
Description
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.
Time Frame
12 months
Title
Mean Minutes per Week of Leisure Time Vigorous Exercise Score 6M
Description
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.
Time Frame
6 months
Title
Mean Minutes per Week of Leisure Time Vigorous Exercise Score 12M
Description
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.
Time Frame
12 months
Title
Mean Depressive Symptom Severity Score: Patient Health Questionnaire-8 6M
Description
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.
Time Frame
6 months
Title
Mean Depressive Symptom Severity Score: Patient Health Questionnaire-8 12M
Description
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.
Time Frame
12 months
Title
Mean Somatic Symptom Severity Score: Patient Health Questionnaire-15 6M
Description
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.
Time Frame
6 months
Title
Mean Somatic Symptom Severity Score: Patient Health Questionnaire-15 12M
Description
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.
Time Frame
12 months
Title
Mean Self-Rated Global Health Score: U.S. National Health Survey 6M
Description
Single item of self-rated health with 5-point Likert response scale of 1 to 5. Higher score reflects poorer health rating.
Time Frame
6 months
Title
Mean Self-Rated Global Health Score: U.S. National Health Survey 12M
Description
Single item of self-rated health with 5-point Likert response scale of 1 to 5. Higher score reflects poorer health rating.
Time Frame
12 months
Title
Mean Healthy Mental Health Days Score: Centers for Disease Control and Prevention 6M
Description
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.
Time Frame
6 months
Title
Mean Healthy Mental Health Days Score: Centers for Disease Control and Prevention 12M
Description
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.
Time Frame
12 months
Title
Mean Physical Health Days Score: Centers for Disease Control and Prevention 6M
Description
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.
Time Frame
6 months
Title
Mean Physical Health Days Score: Centers for Disease Control and Prevention 12M
Description
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.
Time Frame
12 months
Title
Mean Social Role Activity Limitation Score 6M
Description
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.
Time Frame
6 months
Title
Mean Social Role Activity Limitation Score 12M
Description
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.
Time Frame
12 months
Title
Mean Number of Times Hospitalized 6M
Description
Single self-report item asking number of times hospitalized in past 3 months. Possible range 0 to 90. Higher score reflects greater hospitalization episodes.
Time Frame
6 months
Title
Mean Number of Times Hospitalized 12M
Description
Single self-report item asking number of times hospitalized in past 3 months. Possible range 0 to 90. Higher score reflects greater hospitalization episodes.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn M Kneipp, PhD
Organizational Affiliation
UNC-Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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