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

6. Dezember 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

240

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

60 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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."
Verhalten: 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."
Kein Eingriff: Wait-list control
After 3 months, participants will be invited to participate in the intervention. No additional measures or outcomes will be recorded.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Mean steps/day at 3 months
Zeitfenster: 3 months
Measured via pedometer.
3 months
Change from Baseline in Mean Steps/day at 1 month
Zeitfenster: 1 month
Measured via pedometer.
1 month

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, Los Angeles

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2014

Primärer Abschluss (Tatsächlich)

1. August 2016

Studienabschluss (Tatsächlich)

1. Januar 2018

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juli 2014

Zuerst gepostet (Schätzen)

3. Juli 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Dezember 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Dezember 2019

Zuletzt verifiziert

1. Dezember 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RFA-NS-12-007

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