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Culturally Tailoring a Stroke Intervention in Community Senior Centers (SPIRP)

6. december 2019 opdateret af: Catherine A. Sarkisian, University of California, Los Angeles

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

240

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90012
        • Chinatown Service Center
      • Los Angeles, California, Forenede Stater, 90057
        • St. Barnabas Senior Services
      • Montebello, California, Forenede Stater, 90640
        • Mexican American Opportunity Foundation
      • Watts, California, Forenede Stater, 90059
        • Watts Labor Community Action Committee

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Walking Intervention
  1. 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."
Adfærdsmæssigt: Walking Intervention

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."
Ingen indgriben: Wait-list control
After 3 months, participants will be invited to participate in the intervention. No additional measures or outcomes will be recorded.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Mean steps/day at 3 months
Tidsramme: 3 months
Measured via pedometer.
3 months
Change from Baseline in Mean Steps/day at 1 month
Tidsramme: 1 month
Measured via pedometer.
1 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stroke and stroke risk factor knowledge
Tidsramme: baseline, 1 month, and 3 months
Stroke Action Survey (STAT)
baseline, 1 month, and 3 months
Self Efficacy
Tidsramme: baseline, 1 month, and 3 months
Chronic Disease Self Efficacy Scale and the Outcome Expectations Scale for Exercise
baseline, 1 month, and 3 months
Blood pressure
Tidsramme: baseline, 1 month, and 3 months
baseline, 1 month, and 3 months
BMI (kg/m^2)
Tidsramme: baseline, 1 month, and 3 months
baseline, 1 month, and 3 months
LDL cholesterol
Tidsramme: baseline and 3 months
Point-of-service CardioChek meter
baseline and 3 months
Glycosylated hemoglobin
Tidsramme: baseline and 3 months
Measured through finger prick.
baseline and 3 months
c-reactive protein
Tidsramme: baseline and 3 months
measured through finger prick
baseline and 3 months
Healthcare seeking
Tidsramme: baseline and at 3 months
Measure visits to a healthcare provider via survey.
baseline and at 3 months
Medications to control stroke risk factors
Tidsramme: baseline and at 3 months
Via survey, ask for names and doses of medications for hypertension, cholesterol, diabetes.
baseline and at 3 months
Socioeconomic status
Tidsramme: baseline
baseline
Acculturation
Tidsramme: Baseline
Modified Marin Acculturation Scale
Baseline
Medical comorbidities
Tidsramme: Baseline
Katz/Charlson Comorbidity index
Baseline
Social support/network
Tidsramme: Baseline, 1 month, 3 months
Interpersonal Support Evaluation List (ISEL)
Baseline, 1 month, 3 months
Neighborhood Walkability
Tidsramme: baseline
Neighborhood Environment Walkability Scale (NEWS)
baseline
Health-related QOL
Tidsramme: baseline, 1 month, and 3 months
Medical outcomes study, Short Form (SF) 12
baseline, 1 month, and 3 months
Depressive symptoms
Tidsramme: baseline, 1 month, and 3 months
Patient Health Questionnaire
baseline, 1 month, and 3 months
Disability
Tidsramme: baseline, 1 month, and 3 months
Activities of Daily Living (ADL) Summary scale survey
baseline, 1 month, and 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Los Angeles

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2014

Primær færdiggørelse (Faktiske)

1. august 2016

Studieafslutning (Faktiske)

1. januar 2018

Datoer for studieregistrering

Først indsendt

30. juni 2014

Først indsendt, der opfyldte QC-kriterier

1. juli 2014

Først opslået (Skøn)

3. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RFA-NS-12-007

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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