An interventional study of Walking Intervention in Hypertension, Stroke and Sedentary Lifestyle, sponsored by University of California, Los Angeles. Completed at 4 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Prevention
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.
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.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's enrollment of 240 is above the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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."
Behavioral: Walking Intervention
After 3 months, participants will be invited to participate in the intervention. No additional measures or outcomes will be recorded.
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."
Change from Baseline in Mean steps/day at 3 months
Measured via pedometer.
Time frame: 3 months
Change from Baseline in Mean Steps/day at 1 month
Measured via pedometer.
Time frame: 1 month
Stroke and stroke risk factor knowledge
Stroke Action Survey (STAT)
Time frame: baseline, 1 month, and 3 months
Self Efficacy
Chronic Disease Self Efficacy Scale and the Outcome Expectations Scale for Exercise
Time frame: baseline, 1 month, and 3 months
Blood pressure
Time frame: baseline, 1 month, and 3 months
BMI (kg/m^2)
Time frame: baseline, 1 month, and 3 months
LDL cholesterol
Point-of-service CardioChek meter
Time frame: baseline and 3 months
Glycosylated hemoglobin
Measured through finger prick.
Time frame: baseline and 3 months
c-reactive protein
measured through finger prick
Time frame: baseline and 3 months
Healthcare seeking
Measure visits to a healthcare provider via survey.
Time frame: baseline and at 3 months
Medications to control stroke risk factors
Via survey, ask for names and doses of medications for hypertension, cholesterol, diabetes.
Time frame: baseline and at 3 months
Socioeconomic status
Time frame: baseline
Acculturation
Modified Marin Acculturation Scale
Time frame: Baseline
Medical comorbidities
Katz/Charlson Comorbidity index
Time frame: Baseline
Social support/network
Interpersonal Support Evaluation List (ISEL)
Time frame: Baseline, 1 month, 3 months
Neighborhood Walkability
Neighborhood Environment Walkability Scale (NEWS)
Time frame: baseline
Health-related QOL
Medical outcomes study, Short Form (SF) 12
Time frame: baseline, 1 month, and 3 months
Depressive symptoms
Patient Health Questionnaire
Time frame: baseline, 1 month, and 3 months
Disability
Activities of Daily Living (ADL) Summary scale survey
Time frame: baseline, 1 month, and 3 months
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Los Angeles