AtherosclerosisNCT03878290
RiSE to Prevent Cardiovascular Disease in African Americans
A study testing Resilience, Stress, and Ethnicity (RiSE) in people with Atherosclerosis and Stress, run by Loyola University at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate an innovative 8-wk stress reduction program called Resilience, Stress and Ethnicity (RiSE) program designed to reduce chronic stress associated with perceived discrimination among African Americans. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Atherosclerosis, Stress, Hypertension
- What is being tested?
- Resilience, Stress, and Ethnicity (RiSE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 1 Oct 2019
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American
- Living in Maywood community or surrounding area
- Able to speak, read, write English
- Have at least one of the following:
- Body Mass Index (BMI) > 25 (overweight or obese)
- Total cholesterol > 240
Show all 10Show fewer
- Diabetes mellitus
- Systolic blood pressure the same or greater than 120 mmHg or diagnosis of hypertension and/or taking antihypertensive medication
- Atrial fibrillation
- Parental history of myocardial infarction (MI) (heart attack) prior to age 60
Who cannot join
- Current smoker (smoked in last month)
- History of myocardial infarction or ischemic heart disease
- Current cancer
- Active infection
- Major Immune-related disorder (lupus,MS)
- Substance abuse
Show all 9Show fewer
- Immune-altering drugs
- Recent dental procedure (within past 72 hours
- Bleeding gums or periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to evaluate an innovative 8-wk stress reduction program called Resilience, Stress and Ethnicity (RiSE) program designed to reduce chronic stress associated with perceived discrimination among African Americans. African Americans residing in the Maywood community between the ages of 25 and 75 with at least one cardiovascular disease risk factor such as being overweight, having high blood pressure, or diabetes will be enrolled. The following specific aims will be addressed:
Aim 1: Determine the feasibility and acceptability of the program as a strategy to reduce chronic stress in African Americans within the Maywood and surrounding community.
Read more
Aim 2: Examine the extent to which training in RiSE (1) improves psychological well being, (2) decreases inflammatory burden, and (3) reduces cardiovascular risk in African Americans
Participants will be randomized to either the RiSE program or the control (no intervention group). Participants will provide blood and saliva samples as well as complete written questionnaires asking them questions about their health, well-being, and early life at the start of the study, half way through the study (at 4 weeks), at the completion of the intervention (8 weeks) and 3 months after the completion of the intervention).
Read the detailed description
The purpose of this study is to examine an 8-week stress reduction program for African Americans. The aim of this study is to determine the effectiveness of this stress reduction program in improving well-being and reducing risk for heart disease and stroke in African Americans.
No drugs are involved with this study. Participants will be randomized (randomly selected) to either participate in an 8 -week stress reduction program or a control group (no stress reduction program). The stress reduction program entails attending a 2- hour small group class once a week for 8 consecutive weeks at Loyola University in Maywood. Classes will be offered in the evening and will focus on teaching effective strategies for coping with daily stress, particularly stress associated with being an African American.
Blood and saliva samples will be collected at the beginning of the study, in the middle of the program (4 weeks), at the end of the program (8 weeks) and 3 months after the program ends. Blood samples will be analyzed for cholesterol levels, hemoglobin A1c (a measure that reflects blood sugar over time), and cytokines (which reflect inflammation in the body). Saliva samples will be assessed for a hormone called cortisol..
Participants will also complete several written questionnaires to gather information about their stress, social status, perceive discrimination, mood, diet and exercise. Participants will be paid $25 for each of the three data collection time points ($75 total). Those participants who are randomized to attend the stress reduction classes will also be provided $15 for each class that they attend (8 X $15 = $120) to help cover travel expenses.
- Conditions
- Atherosclerosis, Stress, Hypertension, Dyslipidemias, Obesity, Diabetes
- Being tested
- Resilience, Stress, and Ethnicity (RiSE)
- Medical subject headings
- Atherosclerosis, Hypertension, Dyslipidemias, Obesity, Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience, Stress, and Ethnicity (RiSE)Behavioural
Also called RiSE
Group based stress reduction program focused on helping minorities develop coping and empowerment skills
| Study group | Role | What they receive |
|---|---|---|
| 8-week RiSE | Experimental | Participate in 8-week Resilience, Stress, and Ethnicity (RiSE) group based stress reduction program in which participants meet every week for approximately 2 hours for 8 consecutive weeks. Receives: Behavioral: Resilience, Stress, and Ethnicity (RiSE) |
| Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of RiSE intervention: questionnaire
Feasibility of the RiSE intervention will be assessed at the end of the 8 week program. A written questionnaire will be completed by participants and asking participants to rate their level of satisfaction with the program on a scale of 0 to 10 with 0 being not satisfied at all to 10 being most satisfied. In addition, we will track class attendance and attrition rate.
Measured: 8 weeks
Coping
Participants will complete written questionnaires at baseline, 4 weeks, and 8 weeks:
Adaptive Coping. The Ways of Coping Checklist- Revised (WCCL-R) will be used to measure adaptive and non-adaptive coping. This is a 4-point Likert scale (0 to 3 ) that required the respondent to focus on a current stressor and to choose frequency of each of 66 proposed coping strategies. The WCCL-R is comprised of 5 subscales (scores are summed for each subscale) with higher scores indicating higher levels of the attribute measured by the subscale:
Confrontational coping (scores range from 0 to 18) Distancing (scores range from 0 to 18) Self-controlling (scores range from 0 to 21) Seeking social support (scores range from 0 to 18) Accepting responsibility (scores range from 0 to 12) Escape-avoidance (scores range from 0 to 24) Planful problem-solving (scores range from 0 to 15) Positive reappraisal (scores range from 0 to 21)
Measured: 8 weeks
Coping with Discrimination
Coping with Discrimination. The Coping with Discrimination Scale (CDS) is a 25-item scale that assesses coping strategies with discrimination. Items are answered using a 6-point Likert scale format ranging from strongly agree to strongly disagree. Scores are calculated for 5 subscales: Education/advocacy, Internalization, Drug/alcohol use, Resistance, and Detachment. Mean scores for each subscale range from 1 to 6 with higher scores indicating higher presence of the attribute measured.
Measured: 8 weeks
Resilience
Resilience. The Connor-Davidson Resilience Scale- 25 will be used to measure resilience. The Connor Davidson Resilience Scale-25 is a 25 item questionnaire that examines the extent to which statements representing resilience, such as " I am able to adapt when changes occur" are true for the subject. Each item is evaluated on a five point Likert scale ranging from 0-4: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). Scores for items are summed and result in total score between 0-100 with higher scores indicating higher resilience.
Measured: 8 weeks
Secondary outcomes (1)
Inflammatory burden
Inflammatory burden will be measured at baseline and 8 weeks.
Cytokine. ELISA will be used to measure circulating interleukin-6 (IL-6) (R \& D Systems, Minneapolis MN). Sensitivity is < 0.7 pg/ml for IL-6. Intra assay variability is <7 %. Circulating IL-6 will be collected at baseline and 8 wks in both the intervention and control groups. Labs will be centrifuged for 7 minutes and frozen at -80 C for later batch analysis.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start3 Aug 2017
- Primary completion1 Jul 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Saban, Loyola University
- Investigators
- Karen Saban, PhD, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878290
- Sponsor's protocol ID
- 210130
- Status last verified
- Oct 2019
- First submitted
- 14 Mar 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
PubMed 28122885Wong MD, Shapiro MF, Boscardin WJ, Ettner SL. Contribution of major diseases to disparities in mortality. N Engl J Med. 2002 Nov 14;347(20):1585-92. doi: 10.1056/NEJMsa012979.
PubMed 12432046Wagner J, Abbott G. Depression and depression care in diabetes: relationship to perceived discrimination in African Americans. Diabetes Care. 2007 Feb;30(2):364-6. doi: 10.2337/dc06-1756. No abstract available.
PubMed 17259510Belgrave FZ, Abrams JA. Reducing disparities and achieving equity in African American women's health. Am Psychol. 2016 Nov;71(8):723-733. doi: 10.1037/amp0000081.
PubMed 27977253Mouton CP, Hayden M, Southerland JH. Cardiovascular Health Disparities in Underserved Populations. Prim Care. 2017 Mar;44(1):e37-e71. doi: 10.1016/j.pop.2016.09.019.
PubMed 28164826Wagner J, Lampert R, Tennen H, Feinn R. Exposure to Discrimination and Heart Rate Variability Reactivity to Acute Stress among Women with Diabetes. Stress Health. 2015 Aug;31(3):255-62. doi: 10.1002/smi.2542. Epub 2013 Nov 6.
PubMed 24194397Mwendwa DT, Sims RC, Madhere S, Thomas J, Keen LD 3rd, Callender CO, Campbell AL Jr. The influence of coping with perceived racism and stress on lipid levels in African Americans. J Natl Med Assoc. 2011 Jul;103(7):594-601. doi: 10.1016/s0027-9684(15)30385-0.
PubMed 21999034Wyatt SB, Williams DR, Calvin R, Henderson FC, Walker ER, Winters K. Racism and cardiovascular disease in African Americans. Am J Med Sci. 2003 Jun;325(6):315-31. doi: 10.1097/00000441-200306000-00003.
PubMed 12811228Williams DR, Jackson PB. Social sources of racial disparities in health. Health Aff (Millwood). 2005 Mar-Apr;24(2):325-34. doi: 10.1377/hlthaff.24.2.325.
PubMed 15757915Paradies Y. A systematic review of empirical research on self-reported racism and health. Int J Epidemiol. 2006 Aug;35(4):888-901. doi: 10.1093/ije/dyl056. Epub 2006 Apr 3.
PubMed 16585055Sutin AR, Stephan Y, Carretta H, Terracciano A. Perceived discrimination and physical, cognitive, and emotional health in older adulthood. Am J Geriatr Psychiatry. 2015 Feb;23(2):171-9. doi: 10.1016/j.jagp.2014.03.007. Epub 2014 Mar 21.
PubMed 24745563Todorova IL, Falcon LM, Lincoln AK, Price LL. Perceived discrimination, psychological distress and health. Sociol Health Illn. 2010 Sep;32(6):843-61. doi: 10.1111/j.1467-9566.2010.01257.x. Epub 2010 Jul 23.
PubMed 20649891Utsey SO, Payne YA, Jackson ES, Jones AM. Race-related stress, quality of life indicators, and life satisfaction among elderly African Americans. Cultur Divers Ethnic Minor Psychol. 2002 Aug;8(3):224-33. doi: 10.1037/1099-9809.8.3.224.
PubMed 12143100
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RiSE to Prevent Cardiovascular Disease in African Americans
- ClinicalTrials.gov ID
- NCT03878290
- Acronym / sponsor ID
- 210130
- Conditions
- Atherosclerosis, Stress, Hypertension, Dyslipidemias, Obesity, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 18 Mar 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 this pilot study is to evaluate an innovative 8-wk stress reduction program called Resilience, Stress and Ethnicity (RiSE) program designed to reduce chronic stress associated with perceived discrimination among African Americans. African Americans residing in the Maywood community between the ages of 25 and 75 with at least one cardiovascular disease risk factor such as being overweight, having high blood pressure, or diabetes will be enrolled. The following specific aims will be addressed:
Aim 1: Determine the feasibility and acceptability of the program as a strategy to reduce chronic stress in African Americans within the Maywood and surrounding community.
Aim 2: Examine the extent to which training in RiSE (1) improves psychological well being, (2) decreases inflammatory burden, and (3) reduces cardiovascular risk in African Americans
Participants will be randomized to either the RiSE program or the control (no intervention group). Participants will provide blood and saliva samples as well as complete written questionnaires asking them questions about their health, well-being, and early life at the start of the study, half way through the study (at 4 weeks), at the completion of the intervention (8 weeks) and 3 months after the completion of the intervention).
Detailed description
The purpose of this study is to examine an 8-week stress reduction program for African Americans. The aim of this study is to determine the effectiveness of this stress reduction program in improving well-being and reducing risk for heart disease and stroke in African Americans.
No drugs are involved with this study. Participants will be randomized (randomly selected) to either participate in an 8 -week stress reduction program or a control group (no stress reduction program). The stress reduction program entails attending a 2- hour small group class once a week for 8 consecutive weeks at Loyola University in Maywood. Classes will be offered in the evening and will focus on teaching effective strategies for coping with daily stress, particularly stress associated with being an African American.
Blood and saliva samples will be collected at the beginning of the study, in the middle of the program (4 weeks), at the end of the program (8 weeks) and 3 months after the program ends. Blood samples will be analyzed for cholesterol levels, hemoglobin A1c (a measure that reflects blood sugar over time), and cytokines (which reflect inflammation in the body). Saliva samples will be assessed for a hormone called cortisol..
Participants will also complete several written questionnaires to gather information about their stress, social status, perceive discrimination, mood, diet and exercise. Participants will be paid $25 for each of the three data collection time points ($75 total). Those participants who are randomized to attend the stress reduction classes will also be provided $15 for each class that they attend (8 X $15 = $120) to help cover travel expenses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8-week RiSE | Experimental | Behavioral: Resilience, Stress, and Ethnicity (RiSE)Participate in 8-week Resilience, Stress, and Ethnicity (RiSE) group based stress reduction program in which participants meet every week for approximately 2 hours for 8 consecutive weeks. |
| Control | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- African American
- Living in Maywood community or surrounding area
- Able to speak, read, write English
- Have at least one of the following:
- Body Mass Index (BMI) > 25 (overweight or obese)
Key exclusion criteria (9 listed)
- Current smoker (smoked in last month)
- History of myocardial infarction or ischemic heart disease
- Current cancer
- Active infection
- Major Immune-related disorder (lupus,MS)
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 |
|---|---|---|
| Resilience, Stress, and Ethnicity (RiSE)Also: RiSEGroup based stress reduction program focused on helping minorities develop coping and empowerment skills | Behavioural | 8-week RiSE |
Primary outcome
Feasibility of RiSE intervention: questionnaire
Time frame: 8 weeks
Feasibility of the RiSE intervention will be assessed at the end of the 8 week program. A written questionnaire will be completed by participants and asking participants to rate their level of satisfaction with the program on a scale of 0 to 10 with 0 being not satisfied at all to 10 being most satisfied. In addition, we will track class attendance and attrition rate.
Coping
Time frame: 8 weeks
Participants will complete written questionnaires at baseline, 4 weeks, and 8 weeks: Adaptive Coping. The Ways of Coping Checklist- Revised (WCCL-R) will be used to measure adaptive and non-adaptive coping. This is a 4-point Likert scale (0 to 3 ) that required the respondent to focus on a current stressor and to choose frequency of each of 66 proposed coping strategies. The WCCL-R is comprised of 5 subscales (scores are summed for each subscale) with higher scores indicating higher levels of the attribute measured by the subscale: Confrontational coping (scores range from 0 to 18) Distancing (scores range from 0 to 18) Self-controlling (scores range from 0 to 21) Seeking social support (scores range from 0 to 18) Accepting responsibility (scores range from 0 to 12) Escape-avoidance (scores range from 0 to 24) Planful problem-solving (scores range from 0 to 15) Positive reappraisal (scores range from 0 to 21)
Coping with Discrimination
Time frame: 8 weeks
Coping with Discrimination. The Coping with Discrimination Scale (CDS) is a 25-item scale that assesses coping strategies with discrimination. Items are answered using a 6-point Likert scale format ranging from strongly agree to strongly disagree. Scores are calculated for 5 subscales: Education/advocacy, Internalization, Drug/alcohol use, Resistance, and Detachment. Mean scores for each subscale range from 1 to 6 with higher scores indicating higher presence of the attribute measured.
Resilience
Time frame: 8 weeks
Resilience. The Connor-Davidson Resilience Scale- 25 will be used to measure resilience. The Connor Davidson Resilience Scale-25 is a 25 item questionnaire that examines the extent to which statements representing resilience, such as " I am able to adapt when changes occur" are true for the subject. Each item is evaluated on a five point Likert scale ranging from 0-4: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). Scores for items are summed and result in total score between 0-100 with higher scores indicating higher resilience.
1 secondary outcome
Inflammatory burden
Time frame: 8 weeks
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 23 Oct 2019.
- Background: PubMed 28122885Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
- Background: PubMed 12432046Wong MD, Shapiro MF, Boscardin WJ, Ettner SL. Contribution of major diseases to disparities in mortality. N Engl J Med. 2002 Nov 14;347(20):1585-92. doi: 10.1056/NEJMsa012979.
- Background: PubMed 17259510Wagner J, Abbott G. Depression and depression care in diabetes: relationship to perceived discrimination in African Americans. Diabetes Care. 2007 Feb;30(2):364-6. doi: 10.2337/dc06-1756. No abstract available.
- Background: PubMed 27977253Belgrave FZ, Abrams JA. Reducing disparities and achieving equity in African American women's health. Am Psychol. 2016 Nov;71(8):723-733. doi: 10.1037/amp0000081.
- Background: PubMed 28164826Mouton CP, Hayden M, Southerland JH. Cardiovascular Health Disparities in Underserved Populations. Prim Care. 2017 Mar;44(1):e37-e71. doi: 10.1016/j.pop.2016.09.019.
- Background: PubMed 24194397Wagner J, Lampert R, Tennen H, Feinn R. Exposure to Discrimination and Heart Rate Variability Reactivity to Acute Stress among Women with Diabetes. Stress Health. 2015 Aug;31(3):255-62. doi: 10.1002/smi.2542. Epub 2013 Nov 6.
- Background: PubMed 21999034Mwendwa DT, Sims RC, Madhere S, Thomas J, Keen LD 3rd, Callender CO, Campbell AL Jr. The influence of coping with perceived racism and stress on lipid levels in African Americans. J Natl Med Assoc. 2011 Jul;103(7):594-601. doi: 10.1016/s0027-9684(15)30385-0.
- Background: PubMed 12811228Wyatt SB, Williams DR, Calvin R, Henderson FC, Walker ER, Winters K. Racism and cardiovascular disease in African Americans. Am J Med Sci. 2003 Jun;325(6):315-31. doi: 10.1097/00000441-200306000-00003.
- Background: PubMed 15757915Williams DR, Jackson PB. Social sources of racial disparities in health. Health Aff (Millwood). 2005 Mar-Apr;24(2):325-34. doi: 10.1377/hlthaff.24.2.325.
- Background: PubMed 16585055Paradies Y. A systematic review of empirical research on self-reported racism and health. Int J Epidemiol. 2006 Aug;35(4):888-901. doi: 10.1093/ije/dyl056. Epub 2006 Apr 3.
- Background: PubMed 24745563Sutin AR, Stephan Y, Carretta H, Terracciano A. Perceived discrimination and physical, cognitive, and emotional health in older adulthood. Am J Geriatr Psychiatry. 2015 Feb;23(2):171-9. doi: 10.1016/j.jagp.2014.03.007. Epub 2014 Mar 21.
- Background: PubMed 20649891Todorova IL, Falcon LM, Lincoln AK, Price LL. Perceived discrimination, psychological distress and health. Sociol Health Illn. 2010 Sep;32(6):843-61. doi: 10.1111/j.1467-9566.2010.01257.x. Epub 2010 Jul 23.
- Individual participant dataSharing planned: No
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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.
Karen Saban, PhD principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience, Stress, and Ethnicity (RiSE) in people with Atherosclerosis and Stress, run by Loyola University 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 10 inclusion and 9 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 23 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?
Feasibility of RiSE intervention: questionnaire (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT03878290, which also lists 13 linked publications.
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 23 Oct 2019.