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HypertensionSPIRPNCT02181062

Culturally Tailoring a Stroke Intervention in Community Senior Centers

A study testing Walking Intervention in people with Hypertension and Stroke, run by University of California, Los Angeles at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke is a cruel disease that disproportionately kills and disables African-Americans, Latinos, Chinese-Americans and Korean-Americans; seniors with high blood pressure are at particularly high risk. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hypertension, Stroke, Sedentary Lifestyle
What is being tested?
Walking Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
4 sitesUnited States
Study dates
Oct 2014to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age 60 years and older
  • reported history of high blood pressure

Who cannot join

  • younger than 60 years of age
  • not self-identifying as the racial-ethnic group for the intervention planned at that site
  • inability to communicate verbally in the appropriate language in a group setting (either due to lack of language skills, hearing impairment, or other disability)
  • inability to sit in a chair and participate in a 1-hour discussion session
  • inability to walk (the use of assistive devices such as canes and walkers is not an exclusion criterion)
  • not available to attend the baseline data collection session and subsequent weekly intervention sessions
  • plans to move away from the region during the next 6 months
  • lacking cognitive capacity to provide informed consent to participate

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Chinatown Service Center

    Los Angeles, California, 90012

  • St. Barnabas Senior Services

    Los Angeles, California, 90057

  • Mexican American Opportunity Foundation

    Montebello, California, 90640

  • Watts Labor Community Action Committee

    Watts, California, 90059

Other trials in United States

About this study

Official title: Implementing and Testing a Culturally-Tailored Stroke Risk Factor Reduction Intervention in Community Senior Centers

Stroke is a cruel disease that disproportionately kills and disables African-Americans, Latinos, Chinese-Americans and Korean-Americans; seniors with high blood pressure are at particularly high risk. There is a higher incidence of hemorrhagic stroke in African Americans, Latinos, and Chinese Americans relative to non-Latino whites. Asian-Americans have up to 1.4 higher relative risk of stroke death compared to U.S. non-Latino whites. A critical need therefore exists for a sustainable and scalable mechanism to disseminate culturally-tailored stroke knowledge/prevention education in community-based settings where large numbers of these high-risk ethnic minority older adult groups are regularly served, such as in federally funded Multipurpose Senior Centers (MPCs) that exist across the nation (16 of which are in Los Angeles alone).

The overall objective of the proposed study is to develop and test the implementation of a training program for case managers at senior centers to implement a stoke knowledge/prevention education program among four high-risk ethnic minority older adult groups--Korean-American, Chinese-American, African-American, Latinos. We propose to develop a culturally-tailored case manager training curriculum, implement the training at 4 community-based sites, and evaluate the training model using a randomized wait-list controlled trial (n=244) testing the hypothesis that training case managers will decrease older adult participants' stroke risk in a sustainable fashion through increasing their preventative behavior (i.e. increasing their physical activity--mean steps/day--at 1 and 3 months).

Findings will inform similar community-academic partnership efforts around stroke and other disease-specific prevention research/interventions; they will also determine next steps in terms of whether this case manager-centric model can be scaled up and deployed in other community-based settings.

Read the detailed description

As many as 30% of ischemic strokes in the U.S. population can be attributed to physical inactivity. With the goal of eliminating racial/ethnic stroke disparities, this interdisciplinary team proposes to develop, implement, and test a culturally-tailored behavioral intervention to reduce stroke risk (primary prevention) by increasing physical activity (walking) for 4 different racial/ethnic groups (Korean-Americans, Chinese-Americans, African-Americans and Latinos) in Los Angeles community senior centers. The intervention combines stroke and stroke risk factor knowledge (using materials developed by the American Heart Association and American Stroke Association) with theoretically-grounded behavioral change techniques and focuses on reducing stroke risk by increasing physical activity (walking). The study team will conduct focus groups (n=144) to identify culture-specific beliefs about stroke and stroke risk factors, to assess the feasibility and acceptability of the intervention, and will work with Community Action Panels to culturally-tailor the intervention. The intervention will consist of 4 weeks of twice-weekly 1-hour group sessions implemented at 4 community senior centers by trained case managers who are part of the regular senior center staff and supported by congressionally-mandated Older Americans Act Title III funding. The project team will test the effectiveness of the intervention in a randomized wait-list controlled trial (n=240) testing the hypothesis that the intervention will increase mean steps/day (measured by pedometer) at 1 and 3 months, and that the increase will be mediated by changes in stroke/stroke risk knowledge and self-efficacy. Blood pressure will be examined as a secondary outcome. In collaboration with the SPIRP Biomarker Collection \& Analysis Core, the team will collect biological specimens (finger pricks) to explore the relationship between the intervention and biological markers of health; they will also explore the relationship between the intervention and healthcare seeking or taking medications to control stroke risk factors. The team will evaluate the barriers and facilitators of successfully integrating the intervention into the senior centers in order to inform large-scale implementation of the culturally-tailored stroke risk factor reduction/walking intervention.

Being tested
Walking Intervention
Keywords
Stroke, Stroke prevention, older adults, self efficacy, walking, minorities, minority older adults, hypertension, high blood pressure, elderly, sedentary lifestyle
Medical subject headings
Hypertension, Stroke, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walking InterventionBehavioural

    4-week series of twice-weekly 1-hour group-based case-manager-led interactive sessions.

    The intervention will provide the knowledge necessary to improve stroke risk factors. Case manager group leaders will teach that seeing a healthcare provider regularly and monitoring blood pressure prevents strokes; all participants will be provided with the National Institute on Aging booklet, "How to Talk to your Doctor" and the contact information for their healthcare provider.

    Participants will be given a pedometer and be trained to use it to measure steps, with the goal of reaching 10,000 steps each day.

    The intervention will utilize attribution retraining to teach seniors that stroke risk factors including sedentary lifestyle should not be attributed to "old age."

Study groups in NCT02181062
Study groupRoleWhat they receive
Walking InterventionExperimental1. 4-week series of twice-weekly 1-hour group-based case-manager-led interactive sessions. 2. The intervention will provide the knowledge necessary to improve stroke risk factors. Case manager group leaders will teach that seeing a healthcare provider regularly and monitoring blood pressure prevents strokes; all participants will be provided with the National Institute on Aging booklet, "How to Talk to your Doctor" and the contact information for their healthcare provider. 3. Participants will be given a pedometer and be trained to use it to measure steps, with the goal of reaching 10,000 steps each day. 4. The intervention will utilize attribution retraining to teach seniors that stroke risk factors including sedentary lifestyle should not be attributed to "old age."
Receives: Behavioral: Walking Intervention
Wait-list controlNo interventionAfter 3 months, participants will be invited to participate in the intervention. No additional measures or outcomes will be recorded.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Mean steps/day at 3 months

    Measured via pedometer.

    Measured: 3 months

  2. Change from Baseline in Mean Steps/day at 1 month

    Measured via pedometer.

    Measured: 1 month

Secondary outcomes (17)
  1. Stroke and stroke risk factor knowledge

    Stroke Action Survey (STAT)

    Measured: baseline, 1 month, and 3 months

  2. Self Efficacy

    Chronic Disease Self Efficacy Scale and the Outcome Expectations Scale for Exercise

    Measured: baseline, 1 month, and 3 months

  3. Blood pressure

    Measured: baseline, 1 month, and 3 months

  4. BMI (kg/m^2)

    Measured: baseline, 1 month, and 3 months

  5. LDL cholesterol

    Point-of-service CardioChek meter

    Measured: baseline and 3 months

  6. Glycosylated hemoglobin

    Measured through finger prick.

    Measured: baseline and 3 months

  7. c-reactive protein

    measured through finger prick

    Measured: baseline and 3 months

  8. Healthcare seeking

    Measure visits to a healthcare provider via survey.

    Measured: baseline and at 3 months

  9. Medications to control stroke risk factors

    Via survey, ask for names and doses of medications for hypertension, cholesterol, diabetes.

    Measured: baseline and at 3 months

  10. Socioeconomic status

    Measured: baseline

  11. Acculturation

    Modified Marin Acculturation Scale

    Measured: Baseline

  12. Medical comorbidities

    Katz/Charlson Comorbidity index

    Measured: Baseline

  13. Social support/network

    Interpersonal Support Evaluation List (ISEL)

    Measured: Baseline, 1 month, 3 months

  14. Neighborhood Walkability

    Neighborhood Environment Walkability Scale (NEWS)

    Measured: baseline

  15. Health-related QOL

    Medical outcomes study, Short Form (SF) 12

    Measured: baseline, 1 month, and 3 months

  16. Depressive symptoms

    Patient Health Questionnaire

    Measured: baseline, 1 month, and 3 months

  17. Disability

    Activities of Daily Living (ADL) Summary scale survey

    Measured: baseline, 1 month, and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionAug 2016
  4. Study completionJan 2018

Resources

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
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02181062
Sponsor's protocol ID
RFA-NS-12-007
Acronym
SPIRP
Status last verified
Dec 2019
First submitted
30 Jun 2014
Last updated
9 Dec 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Tennstedt S, Howland J, Lachman M, Peterson E, Kasten L, Jette A. A randomized, controlled trial of a group intervention to reduce fear of falling and associated activity restriction in older adults. J Gerontol B Psychol Sci Soc Sci. 1998 Nov;53(6):P384-92. doi: 10.1093/geronb/53b.6.p384.

    PubMed 9826971
  • Chodosh J, Morton SC, Mojica W, Maglione M, Suttorp MJ, Hilton L, Rhodes S, Shekelle P. Meta-analysis: chronic disease self-management programs for older adults. Ann Intern Med. 2005 Sep 20;143(6):427-38. doi: 10.7326/0003-4819-143-6-200509200-00007.

    PubMed 16172441
  • Jones SP, Jenkinson AJ, Leathley MJ, Watkins CL. Stroke knowledge and awareness: an integrative review of the evidence. Age Ageing. 2010 Jan;39(1):11-22. doi: 10.1093/ageing/afp196. Epub 2009 Nov 6.

    PubMed 19897540
  • Cruz-Flores S, Rabinstein A, Biller J, Elkind MS, Griffith P, Gorelick PB, Howard G, Leira EC, Morgenstern LB, Ovbiagele B, Peterson E, Rosamond W, Trimble B, Valderrama AL; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Epidemiology and Prevention; Council on Quality of Care and Outcomes Research. Racial-ethnic disparities in stroke care: the American experience: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011 Jul;42(7):2091-116. doi: 10.1161/STR.0b013e3182213e24. Epub 2011 May 26.

    PubMed 21617147
  • Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available.

    PubMed 22215894
  • Hwang SY, Zerwic JJ. Knowledge of stroke symptoms and risk factors among Korean immigrants in the United States. Res Nurs Health. 2006 Aug;29(4):337-44. doi: 10.1002/nur.20144.

    PubMed 16847912
  • Morgenstern LB, Smith MA, Lisabeth LD, Risser JM, Uchino K, Garcia N, Longwell PJ, McFarling DA, Akuwumi O, Al-Wabil A, Al-Senani F, Brown DL, Moye LA. Excess stroke in Mexican Americans compared with non-Hispanic Whites: the Brain Attack Surveillance in Corpus Christi Project. Am J Epidemiol. 2004 Aug 15;160(4):376-83. doi: 10.1093/aje/kwh225.

    PubMed 15286023
  • Hwang SY, Ryan CJ, Zerwic JJ. Korean immigrants' knowledge of heart attack symptoms and risk factors. J Immigr Minor Health. 2008 Feb;10(1):67-72. doi: 10.1007/s10903-007-9053-y.

    PubMed 17503183
  • Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.

    PubMed 18086926
  • Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet. 2009 May 9;373(9675):1632-44. doi: 10.1016/S0140-6736(09)60371-8.

    PubMed 19427958
  • Leading causes of death and numbers of death, by sex, race, and Hispanic origin: United States, 1980 and 2005. http://www.cdc.gov/omhd/populations/AsianAm/AsianAm.htm#4 Accessed July 22, 2010.

  • 2002 heart and stroke statistical update. Dallas (TX): American Heart Association. 2001 2002.

  • Reeves MJ, Hogan JG, Rafferty AP. Knowledge of stroke risk factors and warning signs among Michigan adults. Neurology. 2002 Nov 26;59(10):1547-52. doi: 10.1212/01.wnl.0000031796.52748.a5.

    PubMed 12451195
  • Ferris A, Robertson RM, Fabunmi R, Mosca L; American Heart Association; American Stroke Association. American Heart Association and American Stroke Association national survey of stroke risk awareness among women. Circulation. 2005 Mar 15;111(10):1321-6. doi: 10.1161/01.CIR.0000157745.46344.A1.

    PubMed 15769775
  • Willey JZ, Williams O, Boden-Albala B. Stroke literacy in Central Harlem: a high-risk stroke population. Neurology. 2009 Dec 8;73(23):1950-6. doi: 10.1212/WNL.0b013e3181c51a7d. Epub 2009 Nov 4.

    PubMed 19890071

Questions about this trial

What is this clinical trial studying?

A study testing Walking Intervention in people with Hypertension and Stroke, run by University of California, Los Angeles at 4 sites 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 2 inclusion and 8 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Change from Baseline in Mean steps/day at 3 months (time frame: 3 months). The study lists 2 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 NCT02181062, which also lists 24 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 9 Dec 2019.

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