Technology-based Intervention and Positive Psychological Training for Blood Pressure Control in African Americans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2019-07-31

Brief Summary

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The purpose of this pilot study is to evaluate the effects of a theoretically-derived technology-based intervention (called TechSuPPorT) and its associated neurological mechanisms for hypertension self-management in African Americans.

The investigators will compare two intervention arms in this study, the Technology-Based Component Only arm (comparison group) and the TechSuPPorT arm (intervention group) in 20 African Americans with uncontrolled hypertension. We aim to:

1. Determine whether there are differences in blood pressure (BP), health-related quality of life (HRQoL), and psychological health (affective well-being, depressive cognitions, anxiety) betweenTechSuPPorT and the Technology-based Component only arm.
2. Determine whether there are differences in self-management behaviors (medication adherence, diet, exercise, self-monitoring BP) between the two groups.
3. Examine whether self-efficacy, decision-making, motivation, patient activation, and perceived stress, and positive emotions mediate the relationship between the interventions and self-management behaviors.
4. Determine if social support, demographics (age, gender, education), discrimination, and technology utilization moderate self-management behaviors, BP, HRQoL, and psychological health.
5. Explore differences in neural processing (diffusion tensor imaging \[DTI\]/ task positive network \[TPN\] task-differentiation), and stress response (cortisol and inflammation panel) between the two groups.

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Detailed Description

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The investigators will conduct a two-arm randomized clinical trial to compare the effects of an Technology-Based Component Only arm and TechSuPPorT on self-management behaviors, BP control, and HRQoL outcomeson cognitive task switching between the DMN and TPN neural networks using Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI). Both groups will be exposed to the three Technology-based components: (a) six weekly web-based modules focused on improving African Americans' knowledge and skills of hypertension management; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe, a smartphone app; and (c) self-monitor BP with study provided BP monitor. Participants in the TechSuPPorT arm will receive the three Technology-based components plus positive psychological training, a structured online training and skill building techniques to promote optimism, resilience, well-being, and self-confidence.

Conditions

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Hypertension Self-management Technology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators hypothesize that African Americans' hypertension self-management behaviors are influenced by the ability of the individual to task differentiate between the DMN and TPN neural processing. Furthermore, such behaviors will lead to improved BP control and HRQoL. Using a two-arm RCT pilot study, investigators will compare the effects of TechSuPPorT and the Technology-based component arm on BP, HRQoL, and psychological health (affective well-being, depressive symptoms, anxiety) and cognitive task differentiation of the DMN and TPN neural networks. Data will be collected at three points: baseline, 8 weeks and 12 weeks. Brain scans (fMRIs) will be captured at baseline and following the intervention at 8 weeks.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Technology-Based Component

A Technology-based interventions comprised of three technolgy components accessible via smartphone to support self-managing hypertension.

Group Type PLACEBO_COMPARATOR

Technology-based Component

Intervention Type BEHAVIORAL

This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension.

TechSupport

A Technology-based interventions comprised of three technolgy components plus positive psychological training accessible by smartphone to support self-managing hypertension.

Group Type EXPERIMENTAL

TechSupport

Intervention Type BEHAVIORAL

The TechSupport intervention is the combination of both an behavioral and emotional intervention.

Technology-based Components: This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension.

Positive Psychological Training (PPT): This intervention will include a structured online training and skill building for PPT accessible by smartphone on techniques to promote optimism, resilience, well-being, and self-confidence.

Interventions

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Technology-based Component

This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension.

Intervention Type BEHAVIORAL

TechSupport

The TechSupport intervention is the combination of both an behavioral and emotional intervention.

Technology-based Components: This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension.

Positive Psychological Training (PPT): This intervention will include a structured online training and skill building for PPT accessible by smartphone on techniques to promote optimism, resilience, well-being, and self-confidence.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* self-identify as African American
* 25 years and older
* diagnosed with hypertension defined, as BP ≥ 130/80 mmHg
* Taking at least one antihypertensive medication(s)
* own an android smartphone
* able to read and understand English

Exclusion Criteria

* are unable to give informed consent or judged to have impaired cognitive ability or severe memory deficits
* currently practicing positive psychological training
* have a history of medical conditions or procedures that is contraindicated for fMRI scanning (cardiac pacemaker, sternal wires, or metal implants)
* have a history of claustrophobia requiring anxiolytics or sedation
* pregnant at time of enrollment

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes