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

6 dicembre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

60 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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."
Comportamentale: 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."
Nessun intervento: Wait-list control
After 3 months, participants will be invited to participate in the intervention. No additional measures or outcomes will be recorded.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Mean steps/day at 3 months
Lasso di tempo: 3 months
Measured via pedometer.
3 months
Change from Baseline in Mean Steps/day at 1 month
Lasso di tempo: 1 month
Measured via pedometer.
1 month

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, Los Angeles

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2014

Completamento primario (Effettivo)

1 agosto 2016

Completamento dello studio (Effettivo)

1 gennaio 2018

Date di iscrizione allo studio

Primo inviato

30 giugno 2014

Primo inviato che soddisfa i criteri di controllo qualità

1 luglio 2014

Primo Inserito (Stima)

3 luglio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 dicembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 dicembre 2019

Ultimo verificato

1 dicembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RFA-NS-12-007

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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