Uncontrolled HypertensionNCT03892057
Internet-based Positive Psychological Intervention for Hispanic/Latino Adult With Hypertension in a Primary Care Setting
A study testing Internet-based Positive Psychological Intervention in people with Uncontrolled Hypertension and Cardiovascular Risk Factor, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Hypertension, Cardiovascular Risk Factor
- What is being tested?
- Internet-based Positive Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2019to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UI Health Pilsen Family Health Center Lower West
Chicago, Illinois, 60608
Maura Stefko-Woznika, MD
About this study
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.
Read the 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.
- Being tested
- Internet-based Positive Psychological Intervention
- Keywords
- Hispanics/Latinos, Underserved Population, Internet-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Positive Psychological InterventionBehavioural
Also called Positive Affect 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 5-, and 12-weeks
Secondary outcomes (10)
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.
Measured: Baseline, 5-, and 12-weeks
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.
Measured: Baseline, 5-, and 12-weeks
General Well-being Schedule: Change in Baseline Emotional Vitality at 5- and 12-weeks
General Well-being Schedule
Measured: Baseline, 5-, and 12-weeks
Life Engagement Test: Change in Baseline Life engagement and Meaning at 5- and 12-weeks
Life Engagement Test
Measured: Baseline, 5-, and 12-weeks
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.
Measured: Baseline, 5-, and 12-weeks
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.
Measured: Baseline, 5-, and 12-weeks
Positive Skills: Change in Baseline Positive Skills at 5- and 12-weeks
Positive Skills
Measured: Baseline, 5-, and 12-weeks
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.
Measured: Baseline, 5-, and 12-weeks
Medication Adherence: Change in Baseline Medication Adherence at 5- and 12-weeks
Medication Adherence
Measured: Baseline, 5-, and 12-weeks
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.
Measured: Baseline, 5-, and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start12 Apr 2019
- Primary completionJan 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Rosenfeld Heart Foundation Grant
- Responsible party
- Sponsor
- Investigators
- Rosalba Hernandez, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892057
- Sponsor's protocol ID
- 08776
- Status last verified
- Jul 2019
- First submitted
- 25 Mar 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32749224
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Positive Psychological Intervention for Hispanic/Latino Adult With Hypertension in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT03892057
- Acronym / sponsor ID
- 08776
- Keywords
- Hispanics/Latinos, Underserved Population, Internet-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Rosenfeld Heart Foundation Grant
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Internet-based Positive Psychological Intervention | Experimental | Behavioral: Internet-based Positive Psychological InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based Positive Psychological InterventionAlso: Positive Affect InterventionThe 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. | Behavioural | Internet-based Positive Psychological Intervention |
Primary outcome
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 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.
10 secondary outcomes
Center for Epidemiological Studies Depression Scale: Change from Baseline Depressive Symptoms at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
Life Orientation Test-Revised: Change from Baseline Dispositional Optimism at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
General Well-being Schedule: Change in Baseline Emotional Vitality at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
Life Engagement Test: Change in Baseline Life engagement and Meaning at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
Perceived Stress Scale: Change from Baseline Perceived Stress at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
Modified Differential Emotions Scale: Change from Baseline Positive and Negative Affect at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
Positive Skills: Change in Baseline Positive Skills at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
Medical Outcomes Study Social Support Survey: Change in Baseline Perceived Social Support at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
Medication Adherence: Change in Baseline Medication Adherence at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
12-Item Short Form Survey: Change in Self-Reported Mental and Physical Health at 5- and 12-weeks
Time frame: Baseline, 5-, and 12-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 32749224Hernandez 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalba Hernandez, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based Positive Psychological Intervention in people with Uncontrolled Hypertension and Cardiovascular Risk Factor, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosalba Hernandez, PhD (217-300-1049, rherna17@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Ambulatory Blood Pressure at 5- and 12-weeks (time frame: Baseline, 5-, and 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03892057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.