Clinical trial NCT03892057: Internet-based Positive Psychological Intervention for Hispanic/Latino Adult With Hypertension in a Primary Care Setting
Official title: Internet-based Positive Psychological Intervention for Hispanic/Latino Adult With Hypertension in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uncontrolled Hypertension
Cardiovascular Risk Factor
Keywords: Hispanics/Latinos
Underserved Population
Internet-based
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Rosenfeld Heart Foundation Grant
First posted: 2019-03-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

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 proof-of-concept study and pilot randomized clinical trial seeks to implement and evaluate a novel internet-based 5-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 randomized trial to determine whether an internet-based 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 internet-based 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.

Eligibility criteria: Inclusion Criteria:

* Hispanics/Latinos recruited from UI Health Pilsen Family Health Center Lower West
* Aged ≥18
* Fluent in English or Spanish with ≥8th grade education
* Elevated sitting blood pressure (≥140/90)
* Ability to read and understand the informed consent
* Ability to access internet from home or in public setting (note, tablet PCs will be made available to all enrolled participants at no charge), and
* Self-reported comfort in with handling of a table computer and website navigation.

Exclusion Criteria:

* Cognitive impairment denoting dementia (assessed using the Short Portable Status Questionnaire-See Appendix E)
* Severely reduced life expectancy (e.g., self-reported diagnosis of metastatic cancer, congestive heart failure, or end-stage kidney disease)
* Self-reported diagnosis of sickle cell disease
* Skin damage or rash in the upper arm region where ambulatory blood pressure monitor is to be placed
* Currently enrolled in psychotherapy, and
* Self-reported history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse; or have severe depression.

Primary outcomes:
measure: Change from Baseline Ambulatory Blood Pressure at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale: Change from Baseline Depressive Symptoms at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
measure: Life Orientation Test-Revised: Change from Baseline Dispositional Optimism at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
measure: General Well-being Schedule: Change in Baseline Emotional Vitality at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
measure: Life Engagement Test: Change in Baseline Life engagement and Meaning at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
measure: Perceived Stress Scale: Change from Baseline Perceived Stress at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
measure: Modified Differential Emotions Scale: Change from Baseline Positive and Negative Affect at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
measure: Positive Skills: Change in Baseline Positive Skills at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
measure: Medical Outcomes Study Social Support Survey: Change in Baseline Perceived Social Support at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
measure: Medication Adherence: Change in Baseline Medication Adherence at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
measure: 12-Item Short Form Survey: Change in Self-Reported Mental and Physical Health at 5- and 12-weeks
timeFrame: Baseline, 5-, and 12-weeks
Other outcomes:
measure: Physical Activity: Change in Hypertension-related Health Behavior(s)
timeFrame: Baseline, 5-, and 12-weeks
measure: Diet: Change in Hypertension-related Health Behavior(s)
timeFrame: Baseline, 5-, and 12-weeks
measure: Change in Heart Rate Variability
timeFrame: Baseline, 5-, and 12-weeks
measure: Change in High-sensitivity C-Reactive Protein
timeFrame: Baseline, 5-, and 12-weeks
Locations:
city: Chicago
country: United States
facility: UI Health Pilsen Family Health Center Lower West
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Rosalba Hernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernandez R, Cohn M, Hernandez A, Daviglus M, Martinez L, Martinez A, Martinez I, Durazo-Arvizu R, Moskowitz J. A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension: Protocol and Design for the inverted exclamation markAlegrate! Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 4;9(8):e17721. doi: 10.2196/17721.