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| ID | Type | Description | Link |
|---|---|---|---|
| U54NS081764 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Southern California | OTHER |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | OTHER |
| Rancho Los Amigos National Rehabilitation Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care Management+Community Health Worker | Experimental | Care management |
|
| Usual Care | Active Comparator | Written materials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care Management+Community Health Worker | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Percentage of Glycated Hemoglobin (Hemoglobin A1C) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara G Vickrey, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Amytis Towfighi, MD | USC - Department of Neurology. Rancho Los Amigos National Rehabilitation Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos National Rehabilitation Center | Downey | California | 90242 | United States | ||
| UCLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28166784 | Background | Towfighi A, Cheng EM, Ayala-Rivera M, McCreath H, Sanossian N, Dutta T, Mehta B, Bryg R, Rao N, Song S, Razmara A, Ramirez M, Sivers-Teixeira T, Tran J, Mojarro-Huang E, Montoya A, Corrales M, Martinez B, Willis P, Macias M, Ibrahim N, Wu S, Wacksman J, Haber H, Richards A, Barry F, Hill V, Mittman B, Cunningham W, Liu H, Ganz DA, Factor D, Vickrey BG. Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED). BMC Neurol. 2017 Feb 6;17(1):24. doi: 10.1186/s12883-017-0792-7. | |
| 12525235 |
Not provided
Not provided
Not applicable; all enrolled participants were assigned to an arm.
The dates of the recruitment period are from February 13, 2014 through August 31, 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not applicable - analysis population is different from participants enrolled
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mm Hg | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
The primary study limitation was the lack of full implementation of the multi-component care management interventions within the intervention arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Vickrey; Chair of Neurology | Icahn School of Medicine at Mount Sinai | 2122415698 | barbara.vickrey@mssm.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2012 | Aug 31, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| Olive View-UCLA Education & Research Institute | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| California Community Foundation | OTHER |
| Cedars-Sinai Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Usual Care | Behavioral | 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. |
|
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. |
| 12 months |
| 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. | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| 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 | 12 months |
| 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 | 12 months |
| 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 | 12 months |
| 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.' | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| 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'. | 12 months |
| 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. | 12 months |
| 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. | 12 Months |
| 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. | 12 Months |
| 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. | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| Los Angeles |
| California |
| 90024 |
| United States |
| LAC+USC Medical Center | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Olive View-UCLA Medical Center | Sylmar | California | 91342 | United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Background |
| Schneider AT, Pancioli AM, Khoury JC, Rademacher E, Tuchfarber A, Miller R, Woo D, Kissela B, Broderick JP. Trends in community knowledge of the warning signs and risk factors for stroke. JAMA. 2003 Jan 15;289(3):343-6. doi: 10.1001/jama.289.3.343. |
| 17577653 | Background | Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19. |
| 16783535 | Background | Simoni JM, Kurth AE, Pearson CR, Pantalone DW, Merrill JO, Frick PA. Self-report measures of antiretroviral therapy adherence: A review with recommendations for HIV research and clinical management. AIDS Behav. 2006 May;10(3):227-45. doi: 10.1007/s10461-006-9078-6. |
| 17315400 | Background | Nicol MB, Thrift AG. Knowledge of risk factors and warning signs of stroke. Vasc Health Risk Manag. 2005;1(2):137-47. doi: 10.2147/vhrm.1.2.137.64085. |
| 34184251 | Derived | Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2. |
| 33587132 | Derived | Towfighi A, Cheng EM, Ayala-Rivera M, Barry F, McCreath H, Ganz DA, Lee ML, Sanossian N, Mehta B, Dutta T, Razmara A, Bryg R, Song SS, Willis P, Wu S, Ramirez M, Richards A, Jackson N, Wacksman J, Mittman B, Tran J, Johnson RR, Ediss C, Sivers-Teixeira T, Shaby B, Montoya AL, Corrales M, Mojarro-Huang E, Castro M, Gomez P, Munoz C, Garcia D, Moreno L, Fernandez M, Lopez E, Valdez S, Haber HR, Hill VA, Rao NM, Martinez B, Hudson L, Valle NP, Vickrey BG; Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) Investigators. Effect of a Coordinated Community and Chronic Care Model Team Intervention vs Usual Care on Systolic Blood Pressure in Patients With Stroke or Transient Ischemic Attack: The SUCCEED Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2036227. doi: 10.1001/jamanetworkopen.2020.36227. |
| 32912091 | Derived | Lin AM, Vickrey BG, Barry F, Lee ML, Ayala-Rivera M, Cheng E, Montoya AV, Mojarro-Huang E, Gomez P, Castro M, Corrales M, Sivers-Teixeira T, Tran JL, Johnson R, Ediss C, Shaby B, Willis P, Sanossian N, Mehta B, Dutta T, Razmara A, Bryg R, Song S, Towfighi A. Factors Associated With Participation in the Chronic Disease Self-Management Program: Findings From the SUCCEED Trial. Stroke. 2020 Oct;51(10):2910-2917. doi: 10.1161/STROKEAHA.119.028022. Epub 2020 Sep 11. |
| Withdrawal by Subject |
|
| Moved out of study region |
|
| Physician Decision |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Index vascular event | Count of Participants | Participants |
|
| Survey language | Count of Participants | Participants |
|
| Location of birth | Count of Participants | Participants |
|
| Employment status prior to vascular event | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
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.
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 12 months |
|
|
|
| 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. | Posted | Geometric Mean | Standard Deviation | mg/L | 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | kg/meter^2 | 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | cm | 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | IPAQ met minutes | 12 months |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 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.' | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 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'. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 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. | This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
|
| 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. | This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis. | Posted | Mean | Standard Deviation | percentage of doses | 12 Months |
|
|
|
|
| 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. | This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis. | Posted | Mean | Standard Deviation | percentage of doses | 12 months |
|
|
|
|
| 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. | This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis. | Posted | Mean | Standard Deviation | percentage of doses | 12 months |
|
|
|
|
| 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. | Only study participants taking antidepressant medication were included in this analysis | Posted | Mean | Standard Deviation | percentage of doses | 12 months |
|
|
|
|
| 4 |
| 241 |
| 0 |
| 241 |
| 0 |
| 241 |
| EG001 | 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. | 7 | 246 | 0 | 246 | 0 | 246 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| unknown |
|
| Unknown |
|
| unknown |
|
| Unknown |
|
| 1 correct stroke sign |
|
| no correct stroke sign |
|
| unknown |
|
| unknown |
|
| No, definitely not |
|
| Unknown |
|
| A good bit of the time |
|
| A little of the time |
|
| None of the time |
|
| Unknown |
|