Secondary Stroke Prevention, Stroke
Conditions
Keywords
Self-management, Chronic Care Model, Community health worker
Brief summary
The purpose of this study is to test a newly-developed outpatient clinic and community-based care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities) for improving control of stroke risk factors among stroke patients in the Los Angeles County safety net, and to measure the costs of running such an intervention, relative to usual care.
Detailed description
Individuals randomized to the intervention arm will receive care from a team that consists of a care manager(CM) who is either a nurse practitioner (NP) or physician assistant (PA), supervised by the site PI, and a community health worker (CHW). The CM will follow care protocols developed by the research team. The CHW will serve as a liaison between the patient and the health care system, and mobilize resources and system support to reduce social isolation and improve stroke risk factor control self-management, through a series of workshops and home visits. Intervention participants will receive home blood pressure monitors. Subjects in either arm are eligible to receive their usual source of care. Five hundred participants who have had a stroke or TIA will be enrolled, randomized to the intervention or to usual care in a 1:1 ratio, and followed for 12 months. The impact of the intervention on systolic blood pressure is the primary study outcome; secondary outcomes are other stroke risk factors. Enrollment will occur at four sites in Los Angeles County, and the study sample is projected to include over 90% socioeconomically disadvantaged individuals from minority groups.
Interventions
BEHAVIORALCare Management+Community Health Worker
Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.
BEHAVIORALUsual Care
Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Sponsors
University of Southern California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Rancho Los Amigos National Rehabilitation Center
Olive View-UCLA Education & Research Institute
National Institute of Neurological Disorders and Stroke (NINDS)
California Community Foundation
Cedars-Sinai Medical Center
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of Los Angeles County+University of Southern California (LAC-USC), Rancho Los Amigos, Olive View-University of California, Los Angeles (UCLA), or Harbor-UCLA * Transient ischemic attack (TIA), ischemic stroke or hemorrhagic stroke within the prior 90 days * English, Spanish, Korean, Mandarin or Cantonese-speaking * 40 years of age or older * Capable of giving informed consent (no proxies will be used to obtain consent) * Systolic blood pressure is 130 mm Hg or greater OR Systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is diagnosed/treated hypertension prior to the stroke or TIA
Exclusion criteria
* Younger than 40 years * Systolic Blood Pressure less than 120 mm Hg OR systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is no known history of hypertension prior to the stroke or TIA * Speaks language other than English, Spanish, Korean, Mandarin, and Cantonese * Inability to comprehend the study because of communication or cognitive impairments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 12 months | Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Glycated Hemoglobin (Hemoglobin A1C) | 12 months | Hemoglobin A1C will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period. |
| Inflammation: C-reactive Protein | 12 months | C-reactive protein will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period. |
| Body Mass Index | 12 months | Body mass index will be measured at 12-months with a height and weight ratio. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period. |
| Waist Circumference | 12 months | Waist circumference will be measured at 12-months according to the National Institutes of Health (NIH) guidelines. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period. |
| Physical Activity | 12 months | The International Physical Activity Questionnaire (IPAQ) Short 7-Day version will be collected as part of the 12 month outcome survey. The questionnaire will also be collected at baseline and 3 months to track changes over the entire study period. The IPAQ score reflects energy expenditure of physical activity, and is reported in units of 'met minutes' which means metabolic equivalent. The minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity. |
| Salt Intake | 12 months | A single question, Are you currently watching or reducing your sodium or salt intake? from the Behavioral Risk Factor Surveillance System 2013, which has a dichotomous 'yes/no' response, will be collected as part of the 12 month outcome survey. The question will also be collected at baseline, 3 months, and at 8 months, to track changes over the entire study period |
| Soda Intake | 12 months | A single question from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The question is During the past month, how often did you drink regular soda or pop that contains sugar? The participant gives a number, and the frequency (per day, per week, or per month) is also recorded. The average daily servings of soda over the prior month is calculated, and the question is scored as a dichotomous variable of greater than or equal to 1 serving of soda per /day versus less than one serving of soda per day. The question will also be collected at baseline and at 3 months, to track changes over the entire study period |
| Fruit and Vegetable Intake | 12 months | Two questions from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The questions are During the past month, how many times did you eat fruit? Do not count juices and During the past month, how many times did you eat any other vegetables like green salad, green beans or potatoes? Do not include fried potatoes. For each question, the participant gives a number, and the frequency (per day, per week, or per month) is also recorded. Responses are converted to a number for day for each question, then summed across the two questions. The question is scored as a dichotomous variable of five or more servings of fruit and vegetables per day versus less than five servings of fruit and vegetables per day. The questions will also be collected at baseline and at 3 months, to track changes over the entire study period |
| Smoking | 12 months | A single question from the California Health Interview Survey 2011-2012 Adult Questionnaire will be collected as part of the 12-month outcome survey. The question asks whether over the interval since the previous study interview, were you smoking cigarettes every day, some days, or not at all? The question will also be collected at baseline (with a time frame of over the prior year) and at 3 months, to track changes over the entire study period. The scoring for this outcome is dichotomous: Smoking = a response of 'every day' or 'some days', versus Not smoking = a response of 'not at all.' |
| Dyslipidemia | 12 months | non-HDL cholesterol will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period. |
| Knowledge About Stroke Risk Factors | 12 months | An adaptation of an existing instrument will be collected as a part of the 12 month survey. An open-ended question about what the participant believes is a stroke risk factor (I would like to ask you about stroke risk factors, those are the things that make it more likely for somebody to have a stroke. From anything you might have heard or read, what do you believe are the risk factors associated with stroke? What else...what else?, will be asked, then converted to three dichotomous variables: correct about at least 3 stroke risk factors versus less than three; correct about at least one stroke risk factor versus none correct; and reports that blood pressure is a stroke risk factor versus does not. This question will also be collected at baseline, 3 months, and 8 months to track changes over the entire study period. |
| Patient Perception of Quality of Stroke Preventative Care | 12 months | An adaptation of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) will be collected as a part of the 12 month questionnaire. It will also be collected at baseline and 3 month to track changes over the entire study period. The CAHPS question was Did you receive from any of your medical care providers the help you needed to make changes in your habits or lifestyle that would improve your health or prevent illness? Response choices are: 'Yes definitely' Yes somewhat' or 'No definitely not'. |
| Vascular Events | 12 months | The Questionnaire for Verifying Stroke Free Status (QVSFS) will be collected as part of the 12 month survey. It will also be collected at baseline and 3 months to track changes over the entire study period. This questionnaire will also be collected every 6 months for up to 24 months after the study is completed to check for vascular events. The scoring was dichotomous: at least one new event (stroke, transient ischemic attack, or heart attack) versus none over the 12-month follow-up period. |
| Medication Adherence - Global | 12 Months | A single item adapted from two questions published elsewhere will be administered at 12 months. The adapted item is In the past week, how much of the time were you able to take your medications exactly as your doctor or nurse told you to? Response choices are 'None of the time,' 'A little of the time,' A good bit of the time,' 'Most of the time,' or 'All of the time.' This item will also be collected at Baseline, 3 Months, and 8 Months, to track changes over the entire study period. |
| Medication Adherence - Blood Pressure Medication | 12 Months | A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for blood pressure medication, using a previously published formula. This will also be collected at 3 months, to track changes over the study period. |
| Medication Adherence - Cholesterol Medication | 12 months | A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for cholesterol medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period. |
| Medication Adherence - Antithrombotic Medication | 12 months | A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for antithrombotic medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period. |
| Medication Adherence - Antidepressant Medication | 12 months | A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for antidepressant medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period. |
| Knowledge About Stroke Signs | 12 months | An open-ended question about what the participant believes is a sign of a stroke (What are the warning signs of a stroke? What else...what else?), will be asked as a part of the 12 month survey. This question will also be collected at 3 months to track changes over the follow-up study period. Correct responses are numbness, weakness, difficulty speaking/understanding, vision disturbance, dizziness, and headache. Responses are scored as 0 correct, 1 correct, 2 correct, and 3 or more correct. |
Countries
United States
Participant flow
Recruitment details
The dates of the recruitment period are from February 13, 2014 through August 31, 2017.
Pre-assignment details
Not applicable; all enrolled participants were assigned to an arm.
Participants by arm
| Arm | Count |
|---|---|
| Care Management+Community Health Worker Care management
Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology. | 241 |
| Usual Care Written materials
Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual. | 246 |
| Total | 487 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 7 |
| Overall Study | Lost to Follow-up | 12 | 12 |
| Overall Study | Moved out of study region | 7 | 10 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 12 |
Baseline characteristics
| Characteristic | Care Management+Community Health Worker | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 9 | 57.1 years STANDARD_DEVIATION 8.9 | 57.0 years STANDARD_DEVIATION 8.7 |
| Education Bachelor's degree and higher | 33 Participants | 55 Participants | 22 Participants |
| Education First to eighth grade | 78 Participants | 160 Participants | 82 Participants |
| Education High school graduate/GED (no college) | 15 Participants | 37 Participants | 22 Participants |
| Education No school/kindergarten only | 12 Participants | 23 Participants | 11 Participants |
| Education Not reported | 15 Participants | 31 Participants | 16 Participants |
| Education Some college | 29 Participants | 66 Participants | 37 Participants |
| Education Some high school but not a high school graduate | 59 Participants | 115 Participants | 56 Participants |
| Employment status prior to vascular event Not reported | 1 Participants | 4 Participants | 3 Participants |
| Employment status prior to vascular event Not working for pay | 115 Participants | 217 Participants | 102 Participants |
| Employment status prior to vascular event Working for pay | 125 Participants | 266 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 170 Participants | 347 Participants | 177 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants | 140 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Index vascular event Intracerebral hemorrhage | 40 Participants | 78 Participants | 38 Participants |
| Index vascular event Ischemic stroke | 190 Participants | 383 Participants | 193 Participants |
| Index vascular event Transient ischemic attack | 11 Participants | 26 Participants | 15 Participants |
| Location of birth Born in the US | 65 Participants | 134 Participants | 69 Participants |
| Location of birth Born outside of the US | 176 Participants | 352 Participants | 176 Participants |
| Location of birth Not reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 87 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) White | 168 Participants | 335 Participants | 167 Participants |
| Region of Enrollment United States | 241 participants | 487 participants | 246 participants |
| Sex: Female, Male Female | 78 Participants | 170 Participants | 92 Participants |
| Sex: Female, Male Male | 163 Participants | 317 Participants | 154 Participants |
| Survey language English | 101 Participants | 207 Participants | 106 Participants |
| Survey language Spanish | 140 Participants | 280 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 241 | 7 / 246 |
| other Total, other adverse events | 0 / 241 | 0 / 246 |
| serious Total, serious adverse events | 0 / 241 | 0 / 246 |
Outcome results
Primary
Systolic Blood Pressure
Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Systolic Blood Pressure | 133.1 mm Hg | Standard Deviation 20.5 |
| Usual Care | Systolic Blood Pressure | 136.9 mm Hg | Standard Deviation 21.9 |
p-value: 0.73Mixed Models Analysis
Secondary
Body Mass Index
Body mass index will be measured at 12-months with a height and weight ratio. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Body Mass Index | 29.5 kg/meter^2 | Standard Deviation 5.9 |
| Usual Care | Body Mass Index | 29.2 kg/meter^2 | Standard Deviation 5.1 |
p-value: 0.86Mixed Models Analysis
Secondary
Dyslipidemia
non-HDL cholesterol will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Dyslipidemia | 98.7 mg/dL | Standard Deviation 47.8 |
| Usual Care | Dyslipidemia | 104.1 mg/dL | Standard Deviation 49.2 |
p-value: 0.77Mixed Models Analysis
Secondary
Fruit and Vegetable Intake
Two questions from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The questions are During the past month, how many times did you eat fruit? Do not count juices and During the past month, how many times did you eat any other vegetables like green salad, green beans or potatoes? Do not include fried potatoes. For each question, the participant gives a number, and the frequency (per day, per week, or per month) is also recorded. Responses are converted to a number for day for each question, then summed across the two questions. The question is scored as a dichotomous variable of five or more servings of fruit and vegetables per day versus less than five servings of fruit and vegetables per day. The questions will also be collected at baseline and at 3 months, to track changes over the entire study period
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Care Management+Community Health Worker | Fruit and Vegetable Intake | >= 5 fruit+vegetables servings/day in past month | 22 Participants |
| Care Management+Community Health Worker | Fruit and Vegetable Intake | <5 fruit+vegetables servings/day in past month | 184 Participants |
| Care Management+Community Health Worker | Fruit and Vegetable Intake | unknown | 35 Participants |
| Usual Care | Fruit and Vegetable Intake | >= 5 fruit+vegetables servings/day in past month | 28 Participants |
| Usual Care | Fruit and Vegetable Intake | <5 fruit+vegetables servings/day in past month | 172 Participants |
| Usual Care | Fruit and Vegetable Intake | unknown | 46 Participants |
p-value: 0.58Mixed Models Analysis
Secondary
Inflammation: C-reactive Protein
C-reactive protein will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.
Time frame: 12 months
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Inflammation: C-reactive Protein | 1.1 mg/L | Standard Deviation 3.2 |
| Usual Care | Inflammation: C-reactive Protein | 1.2 mg/L | Standard Deviation 3.2 |
p-value: 0.002Mixed Models Analysis
Secondary
Knowledge About Stroke Risk Factors
An adaptation of an existing instrument will be collected as a part of the 12 month survey. An open-ended question about what the participant believes is a stroke risk factor (I would like to ask you about stroke risk factors, those are the things that make it more likely for somebody to have a stroke. From anything you might have heard or read, what do you believe are the risk factors associated with stroke? What else...what else?, will be asked, then converted to three dichotomous variables: correct about at least 3 stroke risk factors versus less than three; correct about at least one stroke risk factor versus none correct; and reports that blood pressure is a stroke risk factor versus does not. This question will also be collected at baseline, 3 months, and 8 months to track changes over the entire study period.
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Care Management+Community Health Worker | Knowledge About Stroke Risk Factors | at least 3 correct stroke risk factors named | 54 Participants |
| Care Management+Community Health Worker | Knowledge About Stroke Risk Factors | less than 3 correct stroke risk factors named | 154 Participants |
| Care Management+Community Health Worker | Knowledge About Stroke Risk Factors | unknown | 33 Participants |
| Usual Care | Knowledge About Stroke Risk Factors | at least 3 correct stroke risk factors named | 49 Participants |
| Usual Care | Knowledge About Stroke Risk Factors | less than 3 correct stroke risk factors named | 155 Participants |
| Usual Care | Knowledge About Stroke Risk Factors | unknown | 42 Participants |
p-value: 0.07Mixed Models Analysis
Secondary
Knowledge About Stroke Signs
An open-ended question about what the participant believes is a sign of a stroke (What are the warning signs of a stroke? What else...what else?), will be asked as a part of the 12 month survey. This question will also be collected at 3 months to track changes over the follow-up study period. Correct responses are numbness, weakness, difficulty speaking/understanding, vision disturbance, dizziness, and headache. Responses are scored as 0 correct, 1 correct, 2 correct, and 3 or more correct.
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Care Management+Community Health Worker | Knowledge About Stroke Signs | 2 correct stroke signs | 69 Participants |
| Care Management+Community Health Worker | Knowledge About Stroke Signs | no correct stroke sign | 16 Participants |
| Care Management+Community Health Worker | Knowledge About Stroke Signs | 1 correct stroke sign | 28 Participants |
| Care Management+Community Health Worker | Knowledge About Stroke Signs | unknown | 33 Participants |
| Care Management+Community Health Worker | Knowledge About Stroke Signs | 3 or more correct stroke signs | 95 Participants |
| Usual Care | Knowledge About Stroke Signs | unknown | 42 Participants |
| Usual Care | Knowledge About Stroke Signs | 3 or more correct stroke signs | 65 Participants |
| Usual Care | Knowledge About Stroke Signs | 2 correct stroke signs | 75 Participants |
| Usual Care | Knowledge About Stroke Signs | 1 correct stroke sign | 40 Participants |
| Usual Care | Knowledge About Stroke Signs | no correct stroke sign | 24 Participants |
p-value: 0.0021Wilcoxon (Mann-Whitney)
Secondary
Medication Adherence - Antidepressant Medication
A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for antidepressant medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.
Time frame: 12 months
Population: Only study participants taking antidepressant medication were included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Medication Adherence - Antidepressant Medication | 87.8 percentage of doses | Standard Deviation 32 |
| Usual Care | Medication Adherence - Antidepressant Medication | 96.2 percentage of doses | Standard Deviation 20 |
p-value: 0.25t-test, 2 sided
Secondary
Medication Adherence - Antithrombotic Medication
A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for antithrombotic medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.
Time frame: 12 months
Population: This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Medication Adherence - Antithrombotic Medication | 88.5 percentage of doses | Standard Deviation 30 |
| Usual Care | Medication Adherence - Antithrombotic Medication | 89.4 percentage of doses | Standard Deviation 29 |
p-value: 0.8t-test, 2 sided
Secondary
Medication Adherence - Blood Pressure Medication
A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for blood pressure medication, using a previously published formula. This will also be collected at 3 months, to track changes over the study period.
Time frame: 12 Months
Population: This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Medication Adherence - Blood Pressure Medication | 91.6 percentage of doses | Standard Deviation 24 |
| Usual Care | Medication Adherence - Blood Pressure Medication | 89.4 percentage of doses | Standard Deviation 27 |
p-value: 0.45t-test, 2 sided
Secondary
Medication Adherence - Cholesterol Medication
A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for cholesterol medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.
Time frame: 12 months
Population: This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Medication Adherence - Cholesterol Medication | 86.7 percentage of doses | Standard Deviation 32 |
| Usual Care | Medication Adherence - Cholesterol Medication | 87.1 percentage of doses | Standard Deviation 32 |
p-value: 0.93t-test, 2 sided
Secondary
Medication Adherence - Global
A single item adapted from two questions published elsewhere will be administered at 12 months. The adapted item is In the past week, how much of the time were you able to take your medications exactly as your doctor or nurse told you to? Response choices are 'None of the time,' 'A little of the time,' A good bit of the time,' 'Most of the time,' or 'All of the time.' This item will also be collected at Baseline, 3 Months, and 8 Months, to track changes over the entire study period.
Time frame: 12 Months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Care Management+Community Health Worker | Medication Adherence - Global | All of the time | 148 Participants |
| Care Management+Community Health Worker | Medication Adherence - Global | Most of the time | 31 Participants |
| Care Management+Community Health Worker | Medication Adherence - Global | A good bit of the time | 2 Participants |
| Care Management+Community Health Worker | Medication Adherence - Global | A little of the time | 7 Participants |
| Care Management+Community Health Worker | Medication Adherence - Global | None of the time | 7 Participants |
| Care Management+Community Health Worker | Medication Adherence - Global | Unknown | 46 Participants |
| Usual Care | Medication Adherence - Global | None of the time | 4 Participants |
| Usual Care | Medication Adherence - Global | All of the time | 150 Participants |
| Usual Care | Medication Adherence - Global | A little of the time | 9 Participants |
| Usual Care | Medication Adherence - Global | Most of the time | 27 Participants |
| Usual Care | Medication Adherence - Global | Unknown | 55 Participants |
| Usual Care | Medication Adherence - Global | A good bit of the time | 1 Participants |
p-value: 0.2Mixed Models Analysis
Secondary
Patient Perception of Quality of Stroke Preventative Care
An adaptation of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) will be collected as a part of the 12 month questionnaire. It will also be collected at baseline and 3 month to track changes over the entire study period. The CAHPS question was Did you receive from any of your medical care providers the help you needed to make changes in your habits or lifestyle that would improve your health or prevent illness? Response choices are: 'Yes definitely' Yes somewhat' or 'No definitely not'.
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Care Management+Community Health Worker | Patient Perception of Quality of Stroke Preventative Care | Yes, definitely | 126 Participants |
| Care Management+Community Health Worker | Patient Perception of Quality of Stroke Preventative Care | Yes, somewhat | 30 Participants |
| Care Management+Community Health Worker | Patient Perception of Quality of Stroke Preventative Care | No, definitely not | 36 Participants |
| Care Management+Community Health Worker | Patient Perception of Quality of Stroke Preventative Care | Unknown | 49 Participants |
| Usual Care | Patient Perception of Quality of Stroke Preventative Care | Unknown | 58 Participants |
| Usual Care | Patient Perception of Quality of Stroke Preventative Care | Yes, definitely | 91 Participants |
| Usual Care | Patient Perception of Quality of Stroke Preventative Care | No, definitely not | 55 Participants |
| Usual Care | Patient Perception of Quality of Stroke Preventative Care | Yes, somewhat | 42 Participants |
p-value: 0.32Mixed Models Analysis
Secondary
Percentage of Glycated Hemoglobin (Hemoglobin A1C)
Hemoglobin A1C will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Percentage of Glycated Hemoglobin (Hemoglobin A1C) | 6.5 percentage of glycated hemoglobin | Standard Deviation 1.2 |
| Usual Care | Percentage of Glycated Hemoglobin (Hemoglobin A1C) | 6.6 percentage of glycated hemoglobin | Standard Deviation 1.3 |
Secondary
Physical Activity
The International Physical Activity Questionnaire (IPAQ) Short 7-Day version will be collected as part of the 12 month outcome survey. The questionnaire will also be collected at baseline and 3 months to track changes over the entire study period. The IPAQ score reflects energy expenditure of physical activity, and is reported in units of 'met minutes' which means metabolic equivalent. The minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Physical Activity | 1251 IPAQ met minutes | Standard Deviation 1808 |
| Usual Care | Physical Activity | 1344 IPAQ met minutes | Standard Deviation 1874 |
p-value: 0.46Mixed Models Analysis
Secondary
Salt Intake
A single question, Are you currently watching or reducing your sodium or salt intake? from the Behavioral Risk Factor Surveillance System 2013, which has a dichotomous 'yes/no' response, will be collected as part of the 12 month outcome survey. The question will also be collected at baseline, 3 months, and at 8 months, to track changes over the entire study period
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Care Management+Community Health Worker | Salt Intake | Yes | 181 Participants |
| Care Management+Community Health Worker | Salt Intake | No | 27 Participants |
| Care Management+Community Health Worker | Salt Intake | unknown | 33 Participants |
| Usual Care | Salt Intake | Yes | 168 Participants |
| Usual Care | Salt Intake | No | 34 Participants |
| Usual Care | Salt Intake | unknown | 44 Participants |
p-value: 0.011Mixed Models Analysis
Secondary
Smoking
A single question from the California Health Interview Survey 2011-2012 Adult Questionnaire will be collected as part of the 12-month outcome survey. The question asks whether over the interval since the previous study interview, were you smoking cigarettes every day, some days, or not at all? The question will also be collected at baseline (with a time frame of over the prior year) and at 3 months, to track changes over the entire study period. The scoring for this outcome is dichotomous: Smoking = a response of 'every day' or 'some days', versus Not smoking = a response of 'not at all.'
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Care Management+Community Health Worker | Smoking | Smoking | 25 Participants |
| Care Management+Community Health Worker | Smoking | Not smoking | 182 Participants |
| Care Management+Community Health Worker | Smoking | Unknown | 34 Participants |
| Usual Care | Smoking | Smoking | 22 Participants |
| Usual Care | Smoking | Not smoking | 181 Participants |
| Usual Care | Smoking | Unknown | 43 Participants |
p-value: 0.74Mixed Models Analysis
Secondary
Soda Intake
A single question from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The question is During the past month, how often did you drink regular soda or pop that contains sugar? The participant gives a number, and the frequency (per day, per week, or per month) is also recorded. The average daily servings of soda over the prior month is calculated, and the question is scored as a dichotomous variable of greater than or equal to 1 serving of soda per /day versus less than one serving of soda per day. The question will also be collected at baseline and at 3 months, to track changes over the entire study period
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Care Management+Community Health Worker | Soda Intake | No soda servings per day in past month | 107 Participants |
| Care Management+Community Health Worker | Soda Intake | Any soda servings per day over past month | 99 Participants |
| Care Management+Community Health Worker | Soda Intake | Unknown | 35 Participants |
| Usual Care | Soda Intake | No soda servings per day in past month | 102 Participants |
| Usual Care | Soda Intake | Any soda servings per day over past month | 99 Participants |
| Usual Care | Soda Intake | Unknown | 45 Participants |
p-value: 0.47Mixed Models Analysis
Secondary
Vascular Events
The Questionnaire for Verifying Stroke Free Status (QVSFS) will be collected as part of the 12 month survey. It will also be collected at baseline and 3 months to track changes over the entire study period. This questionnaire will also be collected every 6 months for up to 24 months after the study is completed to check for vascular events. The scoring was dichotomous: at least one new event (stroke, transient ischemic attack, or heart attack) versus none over the 12-month follow-up period.
Time frame: 12 months
Population: This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Care Management+Community Health Worker | Vascular Events | >=one vascular event during the 12-month follow-up | 26 Participants |
| Care Management+Community Health Worker | Vascular Events | No vascular events during the 12-month follow-up | 194 Participants |
| Usual Care | Vascular Events | >=one vascular event during the 12-month follow-up | 29 Participants |
| Usual Care | Vascular Events | No vascular events during the 12-month follow-up | 196 Participants |
p-value: 0.77Chi-squared
Secondary
Waist Circumference
Waist circumference will be measured at 12-months according to the National Institutes of Health (NIH) guidelines. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care Management+Community Health Worker | Waist Circumference | 102.9 cm | Standard Deviation 14.3 |
| Usual Care | Waist Circumference | 101.4 cm | Standard Deviation 12.5 |
p-value: 0.1Mixed Models Analysis