Cardiovascular Risk Factor, Uncontrolled Hypertension
Conditions
Keywords
Hispanics/Latinos, Underserved Population
Brief summary
The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of women have at least one major cardiovascular disease (CVD) risk factor. The American Heart Association emphasizes that current CVD prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies. This observational study and pilot cluster-randomized clinical trial seeks to implement and evaluate a novel 8-week Positive Psychology (PP) Intervention (compared to an attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.
Detailed description
The study features piloting of a cluster-randomized trial to determine whether a positive psychology (PP) intervention is associated with greater improvements in blood pressure compared to an attention control condition. The pilot trial additionally evaluates the efficacy of the PP intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity C-reactive protein. Serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.
Interventions
BEHAVIORALPositive Psychological Intervention
Our culturally-tailored Positive Psychology Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blind to intervention assignment and will only collect clinical data at baseline, 8-, and 12-weeks.
Intervention model description
Cluster-randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hispanics/Latinos recruited from Catholic church sites in Chicago-land area * aged ≥18 * fluent in English or Spanish with ≥8th grade education * elevated 24-hour ambulatory blood pressure levels (systolic BP\> 140 mmHg and \>90 mmHg for diastolic BP).
Exclusion criteria
* Unavailable for study period; have cognitive impairment denoting dementia * have severely reduced life expectancy * are currently enrolled in psychotherapy or take prescribed antidepressants * history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse * have severe depression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks | Baseline, 8-, and 12-weeks | The device, Vitavue, consists of a wireless microcontroller that connects to a desktop computer running proprietary software when operated in real time connected mode. Alternatively, it can be operated in standalone unconnected mode by logging acquired data to an internal memory storage device. The device contains a number of sensors including ECG single channel amplifier, Multispectral Photodiode to record photo pulse plethysmograms, temperature sensor to measure skin temperature, and an accelerometer to record the level of activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks | Baseline, 8-, and 12-weeks | Center for Epidemiological Studies Depression-Scale |
| Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks | Baseline, 8-, and 12-weeks | Life Orientation Test-Revised |
| General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks | Baseline, 8-, and 12-weeks | General Well-being Schedule |
| Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks | Baseline, 8-, and 12-weeks | Life Engagement Test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diet: Change in Hypertension-related Health Behavior(s) | Baseline, 8-, and 12-weeks | Diet using Scored Sodium Questionnaire |
| Change in Heart Rate Variability | Baseline, 8-, and 12-weeks | Beat-to-beat interval |
| Change in High-sensitivity C-Reactive Protein | Baseline, 8-, and 12-weeks | mg/L |
| Physical Activity: Change in Hypertension-related Health Behavior(s) | Baseline, 8-, and 12-weeks | Physical Activity using Fitbit One |
Countries
United States
Contacts
Primary ContactRosalba Hernandez, PhD
Outcome results
None listed