search
Back to results

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

Primary Purpose

Uncontrolled Hypertension, Cardiovascular Risk Factor

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based Positive Psychological Intervention
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncontrolled Hypertension focused on measuring Hispanics/Latinos, Underserved Population, Internet-based

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UI Health Pilsen Family Health Center Lower WestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-based Positive Psychological Intervention

Attention Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
General Well-being Schedule: Change in Baseline Emotional Vitality at 5- and 12-weeks
General Well-being Schedule
Life Engagement Test: Change in Baseline Life engagement and Meaning at 5- and 12-weeks
Life Engagement Test
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.
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.
Positive Skills: Change in Baseline Positive Skills at 5- and 12-weeks
Positive Skills
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.
Medication Adherence: Change in Baseline Medication Adherence at 5- and 12-weeks
Medication Adherence
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.

Full Information

First Posted
March 25, 2019
Last Updated
July 2, 2019
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Rosenfeld Heart Foundation Grant
search

1. Study Identification

Unique Protocol Identification Number
NCT03892057
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Rosenfeld Heart Foundation Grant

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension, Cardiovascular Risk Factor
Keywords
Hispanics/Latinos, Underserved Population, Internet-based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
Outcomes Assessor
Masking Description
Outcome assessor will be blind to intervention assignment and will only collect clinical data at baseline, 5-, and 12-weeks.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet-based Positive Psychological Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based Positive Psychological Intervention
Other Intervention Name(s)
Positive Affect Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Ambulatory Blood Pressure at 5- and 12-weeks
Description
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.
Time Frame
Baseline, 5-, and 12-weeks
Secondary Outcome Measure Information:
Title
Center for Epidemiological Studies Depression Scale: Change from Baseline Depressive Symptoms at 5- and 12-weeks
Description
Center for Epidemiological Studies Depression-Scale. The total score is computed. Scores range from 0-60, with higher scores indicating greater symptoms of depression.
Time Frame
Baseline, 5-, and 12-weeks
Title
Life Orientation Test-Revised: Change from Baseline Dispositional Optimism at 5- and 12-weeks
Description
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.
Time Frame
Baseline, 5-, and 12-weeks
Title
General Well-being Schedule: Change in Baseline Emotional Vitality at 5- and 12-weeks
Description
General Well-being Schedule
Time Frame
Baseline, 5-, and 12-weeks
Title
Life Engagement Test: Change in Baseline Life engagement and Meaning at 5- and 12-weeks
Description
Life Engagement Test
Time Frame
Baseline, 5-, and 12-weeks
Title
Perceived Stress Scale: Change from Baseline Perceived Stress at 5- and 12-weeks
Description
Perceived Stress Scale. The total score is computed. Scores range from 0 to 16, with higher scores indicating greater perceived stress.
Time Frame
Baseline, 5-, and 12-weeks
Title
Modified Differential Emotions Scale: Change from Baseline Positive and Negative Affect at 5- and 12-weeks
Description
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.
Time Frame
Baseline, 5-, and 12-weeks
Title
Positive Skills: Change in Baseline Positive Skills at 5- and 12-weeks
Description
Positive Skills
Time Frame
Baseline, 5-, and 12-weeks
Title
Medical Outcomes Study Social Support Survey: Change in Baseline Perceived Social Support at 5- and 12-weeks
Description
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.
Time Frame
Baseline, 5-, and 12-weeks
Title
Medication Adherence: Change in Baseline Medication Adherence at 5- and 12-weeks
Description
Medication Adherence
Time Frame
Baseline, 5-, and 12-weeks
Title
12-Item Short Form Survey: Change in Self-Reported Mental and Physical Health at 5- and 12-weeks
Description
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.
Time Frame
Baseline, 5-, and 12-weeks
Other Pre-specified Outcome Measures:
Title
Physical Activity: Change in Hypertension-related Health Behavior(s)
Description
Self-Reported Physical Activity
Time Frame
Baseline, 5-, and 12-weeks
Title
Diet: Change in Hypertension-related Health Behavior(s)
Description
Sodium Intake Diet using Scored Sodium Questionnaire. The total score is computed. Scores range from 0-215, with higher scores indicating greater sodium intake.
Time Frame
Baseline, 5-, and 12-weeks
Title
Change in Heart Rate Variability
Description
Beat-to-beat interval
Time Frame
Baseline, 5-, and 12-weeks
Title
Change in High-sensitivity C-Reactive Protein
Description
mg/L
Time Frame
Baseline, 5-, and 12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalba Hernandez, PhD
Phone
217-300-1049
Email
rherna17@illinois.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosalba Hernandez, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
UI Health Pilsen Family Health Center Lower West
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maura Stefko-Woznika, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data may be available by 2022 for a 5-year period.
IPD Sharing 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.
Citations:
PubMed Identifier
32749224
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs