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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03892057
Other study ID # 08776
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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