Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

6. prosince 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

240

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

60 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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."
Behaviorální: 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."
Žádný zásah: Wait-list control
After 3 months, participants will be invited to participate in the intervention. No additional measures or outcomes will be recorded.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Mean steps/day at 3 months
Časové okno: 3 months
Measured via pedometer.
3 months
Change from Baseline in Mean Steps/day at 1 month
Časové okno: 1 month
Measured via pedometer.
1 month

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Stroke and stroke risk factor knowledge
Časové okno: baseline, 1 month, and 3 months
Stroke Action Survey (STAT)
baseline, 1 month, and 3 months
Self Efficacy
Časové okno: 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
Časové okno: baseline, 1 month, and 3 months
baseline, 1 month, and 3 months
BMI (kg/m^2)
Časové okno: baseline, 1 month, and 3 months
baseline, 1 month, and 3 months
LDL cholesterol
Časové okno: baseline and 3 months
Point-of-service CardioChek meter
baseline and 3 months
Glycosylated hemoglobin
Časové okno: baseline and 3 months
Measured through finger prick.
baseline and 3 months
c-reactive protein
Časové okno: baseline and 3 months
measured through finger prick
baseline and 3 months
Healthcare seeking
Časové okno: baseline and at 3 months
Measure visits to a healthcare provider via survey.
baseline and at 3 months
Medications to control stroke risk factors
Časové okno: 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
Časové okno: baseline
baseline
Acculturation
Časové okno: Baseline
Modified Marin Acculturation Scale
Baseline
Medical comorbidities
Časové okno: Baseline
Katz/Charlson Comorbidity index
Baseline
Social support/network
Časové okno: Baseline, 1 month, 3 months
Interpersonal Support Evaluation List (ISEL)
Baseline, 1 month, 3 months
Neighborhood Walkability
Časové okno: baseline
Neighborhood Environment Walkability Scale (NEWS)
baseline
Health-related QOL
Časové okno: baseline, 1 month, and 3 months
Medical outcomes study, Short Form (SF) 12
baseline, 1 month, and 3 months
Depressive symptoms
Časové okno: baseline, 1 month, and 3 months
Patient Health Questionnaire
baseline, 1 month, and 3 months
Disability
Časové okno: baseline, 1 month, and 3 months
Activities of Daily Living (ADL) Summary scale survey
baseline, 1 month, and 3 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of California, Los Angeles

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. října 2014

Primární dokončení (Aktuální)

1. srpna 2016

Dokončení studie (Aktuální)

1. ledna 2018

Termíny zápisu do studia

První předloženo

30. června 2014

První předloženo, které splnilo kritéria kontroly kvality

1. července 2014

První zveřejněno (Odhad)

3. července 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. prosince 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. prosince 2019

Naposledy ověřeno

1. prosince 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RFA-NS-12-007

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Walking Intervention

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Egypt

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit