Chronic DiseaseSMARTLifeNCT04116463
Testing the Effects of the CDSMP Among Lower-to-Middle Wage Workers
A study testing Chronic Disease Self-Management Program (CDSMP) and Financial Self-Management Program (FSMP) in people with Chronic Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Chronic Disease Self-Management Program (CDSMP) and Financial Self-Management Program (FSMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2015to 26 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Chronic Disease Self-Management Program (CDSMP), Financial Self-Management Program (FSMP)
- Keywords
- lower-wage workers, chronic disease, self-management
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Disease Self-Management Program (CDSMP)Behavioural
Also called Health Self-Management Program
Financial Self-Management Program (FSMP)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Financial Self-Management Program (FSMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start29 Jun 2015
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized at the individual level into intervention or attention-control group.
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Shawn M Kneipp, PhD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116463
- Sponsor's protocol ID
- 15-0962
- Other IDs
- 1U48DP005017-01
- Acronym
- SMARTLife
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effects of the CDSMP Among Lower-to-Middle Wage Workers
- ClinicalTrials.gov ID
- NCT04116463
- Acronym / sponsor ID
- SMARTLife / 15-0962
- Conditions
- Chronic Disease
- Keywords
- lower-wage workers, chronic disease, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized at the individual level into intervention or attention-control group.
| Arm | Type | Receives |
|---|---|---|
| CDSMP | Experimental | Behavioral: Chronic Disease Self-Management Program (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. |
| Financial Self-Management | Active comparator | Behavioral: Financial Self-Management Program (FSMP)Financial self-management course delivered in 3 modules, with a delivery time of approximately 1 hour per module. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Disease Self-Management Program (CDSMP)Also: Health Self-Management Program | Behavioural | CDSMP |
| Financial Self-Management Program (FSMP) | Behavioural | Financial Self-Management |
Primary outcome
Mean Work Limitations Questionnaire-25 Score 6M: Percent productivity loss due to presenteeism
Time frame: 6 months
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
Time frame: 12 months
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
Time frame: 6 months
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
Time frame: 12 months
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.
22 secondary outcomes
Mean Communication with Healthcare Provider Score 6M
Time frame: 6 months
Mean Communication with Healthcare Provider Score 12M
Time frame: 12 months
Medication adherence: Proportions and Means 6M
Time frame: 6 months
Medication adherence Score: Proportions and Means 12M
Time frame: 12 months
Mean Minutes per Week of Leisure Time Light or Moderate Exercise Score 6M
Time frame: 6 months
Mean Minutes per Week of Leisure Time Light or Moderate Exercise Score 12M
Time frame: 12 months
Mean Minutes per Week of Leisure Time Vigorous Exercise Score 6M
Time frame: 6 months
Mean Minutes per Week of Leisure Time Vigorous Exercise Score 12M
Time frame: 12 months
Mean Depressive Symptom Severity Score: Patient Health Questionnaire-8 6M
Time frame: 6 months
Mean Depressive Symptom Severity Score: Patient Health Questionnaire-8 12M
Time frame: 12 months
Mean Somatic Symptom Severity Score: Patient Health Questionnaire-15 6M
Time frame: 6 months
Mean Somatic Symptom Severity Score: Patient Health Questionnaire-15 12M
Time frame: 12 months
Mean Self-Rated Global Health Score: U.S. National Health Survey 6M
Time frame: 6 months
Mean Self-Rated Global Health Score: U.S. National Health Survey 12M
Time frame: 12 months
Mean Healthy Mental Health Days Score: Centers for Disease Control and Prevention 6M
Time frame: 6 months
Mean Healthy Mental Health Days Score: Centers for Disease Control and Prevention 12M
Time frame: 12 months
Mean Physical Health Days Score: Centers for Disease Control and Prevention 6M
Time frame: 6 months
Mean Physical Health Days Score: Centers for Disease Control and Prevention 12M
Time frame: 12 months
Mean Social Role Activity Limitation Score 6M
Time frame: 6 months
Mean Social Role Activity Limitation Score 12M
Time frame: 12 months
Mean Number of Times Hospitalized 6M
Time frame: 6 months
Mean Number of Times Hospitalized 12M
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn M Kneipp, PhD principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Disease Self-Management Program (CDSMP) and Financial Self-Management Program (FSMP) in people with Chronic Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Work Limitations Questionnaire-25 Score 6M: Percent productivity loss due to presenteeism (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.