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

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ClinicalTrials.gov Identifier: NCT03892057
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
Rosenfeld Heart Foundation Grant
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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 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.

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Cardiovascular Risk Factor Behavioral: Internet-based Positive Psychological Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor will be blind to intervention assignment and will only collect clinical data at baseline, 5-, and 12-weeks.
Primary Purpose: Treatment
Official Title: Internet-based Positive Psychological Intervention for Hispanic/Latino Adult With Hypertension in a Primary Care Setting
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Internet-based Positive Psychological Intervention
Our 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
Our 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. 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. The intervention covers the following 8 skills: Personal Strengths, Positive Events, Capitalizing, Gratitude, Optimism, Mindfulness, Positive Psychological Reappraisal, and Altruistic Behavior.
Other Name: Positive Affect Intervention

No Intervention: Wait list control
Individuals will complete computerized surveys to document the frequency of positive and negative emotions experienced in daily life. The wait-list 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.



Primary Outcome Measures :
  1. Change from Baseline Ambulatory Blood Pressure at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    The ambulatory blood pressure monitor (the Spacelabs Healthcare 90217A ABPM) will capture 24-hour daytime and nighttime blood pressure reading in the natural environment and will capture heart rate variability. The ambulatory blood pressure monitor will record the subject blood pressure periodically every 30 minutes to one hour and the data will be stored inthe 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.


Secondary Outcome Measures :
  1. Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    Center for Epidemiological Studies Depression-Scale

  2. Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    Life Orientation Test-Revised

  3. General Well-being Schedule: Change in Baseline Emotional Vitality at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    General Well-being Schedule

  4. Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    Life Engagement Test

  5. Perceived Stress Scale (PSS): Change from Baseline Perceived Stress at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    Perceived Stress Scale

  6. Modified Differential Emotions Scale (mDES): Change from Baseline Positive Emotions at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    Modified Differential Emotions Scale

  7. Positive Skills: Change in Baseline Positive Skills at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    Positive Skills

  8. Medical Outcomes Study (MOS) Social Support Survey: Change in Baseline Social Support at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    Medical Outcomes Study Social Support Survey

  9. Medication Adherence: Change in Baseline Medication Adherence at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    Medication Adherence

  10. 12-Item Short Form Survey (SF-12): Change in Self-Reported Mental and Physical Health at 5- and 12-weeks [ Time Frame: Baseline, 5-, and 12-weeks ]
    12-Item Short Form Survey


Other Outcome Measures:
  1. Physical Activity: Change in Hypertension-related Health Behavior(s) [ Time Frame: Baseline, 5-, and 12-weeks ]
    Self-Reported Physical Activity

  2. Diet: Change in Hypertension-related Health Behavior(s) [ Time Frame: Baseline, 5-, and 12-weeks ]
    Diet using Scored Sodium Questionnaire

  3. Change in Heart Rate Variability [ Time Frame: Baseline, 5-, and 12-weeks ]
    Beat-to-beat interval

  4. Change in High-sensitivity C-Reactive Protein [ Time Frame: Baseline, 5-, and 12-weeks ]
    mg/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892057


Contacts
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Contact: Rosalba Hernandez 217-300-1049 rherna17@illinois.edu

Locations
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United States, Illinois
UI Health Pilsen Family Health Center Lower West Not yet recruiting
Chicago, Illinois, United States, 60608
Contact: Maura Stefko-Woznika, MD         
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Rosenfeld Heart Foundation Grant

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03892057     History of Changes
Other Study ID Numbers: 08776
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We 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, we will work with the Research Data Service at the University Library to determine appropriate venues for archiving and sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Illinois at Urbana-Champaign:
Hispanics/Latinos
Underserved Population
Internet-based

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases