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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03892057
• Other study ID #: 08776
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2019
• Est. completion date: June 2021

Study information

• Verified date: July 2019
• Source: University of Illinois at Urbana-Champaign
• Contact: Rosalba Hernandez, PhD
• Phone: 217-300-1049
• Email: rherna17[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Hypertension
• Uncontrolled Hypertension

Intervention

Behavioral:
• Internet-based Positive Psychological Intervention
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.

Locations

Country	Name	City	State
United States	UI Health Pilsen Family Health Center Lower West	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Rosenfeld Heart Foundation Grant

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity: Change in Hypertension-related Health Behavior(s)	Self-Reported Physical Activity	Baseline, 5-, and 12-weeks
Other	Diet: Change in Hypertension-related Health Behavior(s)	Sodium Intake Diet using Scored Sodium Questionnaire. The total score is computed. Scores range from 0-215, with higher scores indicating greater sodium intake.	Baseline, 5-, and 12-weeks
Other	Change in Heart Rate Variability	Beat-to-beat interval	Baseline, 5-, and 12-weeks
Other	Change in High-sensitivity C-Reactive Protein	mg/L	Baseline, 5-, and 12-weeks
Primary	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	Center for Epidemiological Studies Depression Scale: Change from Baseline Depressive Symptoms at 5- and 12-weeks	Center for Epidemiological Studies Depression-Scale. The total score is computed. Scores range from 0-60, with higher scores indicating greater symptoms of depression.	Baseline, 5-, and 12-weeks
Secondary	Life Orientation Test-Revised: Change from Baseline Dispositional Optimism at 5- and 12-weeks	Life Orientation Test-Revised. Two sub-scale scores are computed for affirming optimism and disaffirming pessimism. Scores range from 0-12 on each sub-scale and summed, with higher scores indicating greater optimism.	Baseline, 5-, and 12-weeks
Secondary	General Well-being Schedule: Change in Baseline Emotional Vitality at 5- and 12-weeks	General Well-being Schedule	Baseline, 5-, and 12-weeks
Secondary	Life Engagement Test: Change in Baseline Life engagement and Meaning at 5- and 12-weeks	Life Engagement Test	Baseline, 5-, and 12-weeks
Secondary	Perceived Stress Scale: Change from Baseline Perceived Stress at 5- and 12-weeks	Perceived Stress Scale. The total score is computed. Scores range from 0 to 16, with higher scores indicating greater perceived stress.	Baseline, 5-, and 12-weeks
Secondary	Modified Differential Emotions Scale: Change from Baseline Positive and Negative Affect at 5- and 12-weeks	Modified Differential Emotions Scale. Two sub-scale scores are computed for positive emotions and negative emotions. The sub-scales are averaged, with higher scores indicating higher positive or negative emotions.	Baseline, 5-, and 12-weeks
Secondary	Positive Skills: Change in Baseline Positive Skills at 5- and 12-weeks	Positive Skills	Baseline, 5-, and 12-weeks
Secondary	Medical Outcomes Study Social Support Survey: Change in Baseline Perceived Social Support at 5- and 12-weeks	Medical Outcomes Study Social Support Survey. Four sub-scale scores are computed for 1) emotional/informational support 2) Tangible support 3) Affectionate Support and 4)Positive Social Interaction. An additional item asks the participant to quantify the number of persons of support. Sub-scale scores range from 1-5, and they are summed for a total score for perceived social support ranging from 0-25, with higher scores indicating greater perceived support.	Baseline, 5-, and 12-weeks
Secondary	Medication Adherence: Change in Baseline Medication Adherence at 5- and 12-weeks	Medication Adherence	Baseline, 5-, and 12-weeks
Secondary	12-Item Short Form Survey: Change in Self-Reported Mental and Physical Health at 5- and 12-weeks	12-Item Short Form Survey. The total score is computed. Scores range from 0-100, with higher scores indicating greater perceived physical and mental health.	Baseline, 5-, and 12-weeks