Internet-based Positive Psychological Intervention for Hispanic/Latino Adult With Hypertension in a Primary Care Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from Baseline Ambulatory Blood Pressure at 5- and 12-weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blind to intervention assignment and will only collect clinical data at baseline, 5-, and 12-weeks.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hispanics/Latinos recruited from UI Health Pilsen Family Health Center Lower West
- •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.
排除标准
- •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.
研究组 & 干预措施
Internet-based Positive Psychological Intervention
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.
干预措施: Internet-based Positive Psychological Intervention (Behavioral)
Attention Control Group
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.
结局指标
主要结局
Change from Baseline Ambulatory Blood Pressure at 5- and 12-weeks
时间窗: 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.
次要结局
- Center for Epidemiological Studies Depression Scale: Change from Baseline Depressive Symptoms at 5- and 12-weeks(Baseline, 5-, and 12-weeks)
- Life Orientation Test-Revised: Change from Baseline Dispositional Optimism at 5- and 12-weeks(Baseline, 5-, and 12-weeks)
- Medication Adherence: Change in Baseline Medication Adherence at 5- and 12-weeks(Baseline, 5-, and 12-weeks)
- General Well-being Schedule: Change in Baseline Emotional Vitality at 5- and 12-weeks(Baseline, 5-, and 12-weeks)
- Perceived Stress Scale: Change from Baseline Perceived Stress at 5- and 12-weeks(Baseline, 5-, and 12-weeks)
- Positive Skills: Change in Baseline Positive Skills at 5- and 12-weeks(Baseline, 5-, and 12-weeks)
- Life Engagement Test: Change in Baseline Life engagement and Meaning at 5- and 12-weeks(Baseline, 5-, and 12-weeks)
- Modified Differential Emotions Scale: Change from Baseline Positive and Negative Affect at 5- and 12-weeks(Baseline, 5-, and 12-weeks)
- 12-Item Short Form Survey: Change in Self-Reported Mental and Physical Health at 5- and 12-weeks(Baseline, 5-, and 12-weeks)
- Medical Outcomes Study Social Support Survey: Change in Baseline Perceived Social Support at 5- and 12-weeks(Baseline, 5-, and 12-weeks)