Internet-based Positive Psychological Intervention for Hispanic/Latino Adult With Hypertension in a Primary Care Setting

NCT03892057 | Unknown

• 1 other identifier: 08776
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncontrolled Hypertension; Cardiovascular Risk Factor

Keywords

Hispanics/Latinos; Underserved Population; Internet-based

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Ambulatory Blood Pressure at 5- and 12-weeks

  The ambulatory blood pressure monitor (the Spacelabs Healthcare 90217A ABPM) will capture 24-hour daytime and nighttime systolic and diastolic blood pressure reading in the natural environment and will capture heart rate variability. The ambulatory blood pressure monitor will record the subject's systolic and diastolic blood pressure periodically every 30 minutes to one hour and the data will be stored in the internal memory until uploaded to a companion application for visualization and analysis. In addition to ambulatory blood pressure the wearable device will record pulse waves on a beat to beat basis from which heart rate variability will be calculated and analyzed.

  Baseline, 5-, and 12-weeks

Secondary Outcomes (10)

• Center for Epidemiological Studies Depression Scale: Change from Baseline Depressive Symptoms at 5- and 12-weeks

  Baseline, 5-, and 12-weeks

• Life Orientation Test-Revised: Change from Baseline Dispositional Optimism at 5- and 12-weeks

  Baseline, 5-, and 12-weeks

• General Well-being Schedule: Change in Baseline Emotional Vitality at 5- and 12-weeks

  Baseline, 5-, and 12-weeks

• Life Engagement Test: Change in Baseline Life engagement and Meaning at 5- and 12-weeks

  Baseline, 5-, and 12-weeks

• Perceived Stress Scale: Change from Baseline Perceived Stress at 5- and 12-weeks

  Baseline, 5-, and 12-weeks

Other Outcomes (4)

• Physical Activity: Change in Hypertension-related Health Behavior(s)

  Baseline, 5-, and 12-weeks

• Diet: Change in Hypertension-related Health Behavior(s)

  Baseline, 5-, and 12-weeks

• Change in Heart Rate Variability

  Baseline, 5-, and 12-weeks

Study Arms (2)

Internet-based Positive Psychological Intervention

EXPERIMENTAL

The investigator's culturally-tailored internet-based Positive Psychology (PP) 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.

Behavioral: Internet-based Positive Psychological Intervention

Attention Control Group

NO INTERVENTION

Participants will complete computerized surveys to document the frequency of positive and negative emotions experienced in daily life. The attention control group will be given the option to access our positive psychological intervention and associated content via the web at the conclusion of the 12-week data collection phase.

Interventions

Internet-based Positive Psychological Intervention BEHAVIORAL

The investigator's culturally-tailored internet-based 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, e.g., mindfulness/meditation. The current 5-week Internet-based intervention will be delivered via a secure website which participants will access at home (or in a public setting with Wi-Fi) using an assigned username and password. The on-line program includes didactic material and "home practice" with participants logging into the website 3-4 times per week for 15 to 20 minute sessions. In addition to weekly on-line instruction, participants are assigned homework as a means of incorporating skills learned into their day-to-day activities.

Also known as: Positive Affect Intervention

Internet-based Positive Psychological Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Rosenfeld Heart Foundation Grant: collaborator

Study Sites (1)

UI Health Pilsen Family Health Center Lower West

Chicago, Illinois, 60608, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 32749224 DERIVED

Study Officials

• Rosalba Hernandez, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalba Hernandez, PhD

CONTACT

217-300-1049; rherna17@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blind to intervention assignment and will only collect clinical data at baseline, 5-, and 12-weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: April 12, 2019
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data may be available by 2022 for a 5-year period.
• Access Criteria: The investigator will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to use data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate technology; and (3) a commitment to destroy or return data after analyses are completed. If additional outputs result from this research that would be appropriate to share with a wider audience, the investigator will work with the Research Data Service at the University Library to determine appropriate venues for archiving and sharing.

Locations

US (1)