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Completed

NCT Number: NCT03722667

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

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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Key information

Conditions

Hypertension Cardiovascular Diseases Self-management Technology Vascular Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technology-based Component

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

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.

Primary outcomes

  1. Change in systolic and diastolic blood pressure

    Time frame: Baseline to 8 weeks and 12 weeks

    Measure of participants' in clinic blood pressure (average of three blood pressure readings)

  2. PROMIS Global Health-10 [health-related quality of life]

    Time frame: Baseline to 8 weeks and 12 weeks

    Change in total summed score on PROMIS Global Health-10. Higher scores indicate greater health-related quality of life. Range is 4-20.

  3. PROMIS Short Form, Positive Affect -15a [positive affect and well-being]

    Time frame: Baseline to 8 weeks and 12 weeks

    Change in total summed score on PROMIS Short Form, Positive Affect 15a. Higher scores indicate greater positive affect and well being. Range is 15-45.

  4. PROMIS- 29, Depression Subscale 4a [depressive symptoms]

    Time frame: Baseline to 8 weeks and 12 weeks

    Change in total summed PROMIS-29, Depression Subscale 4a. Higher scores indicate greater depressive symptoms. Range is 4 to 20.

  5. PROMIS- 29, Anxiety Subscale 4a [anxiety symptoms]

    Time frame: Baseline to 8 weeks and 12 weeks

    Change in total summed PROMIS-29, Anxiety subscale. Higher scores indicate greater anxiety. Range is 4-20.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • University Hospitals Cleveland Medical Center

Registry information

Official study title

The Effects of Technology-based Intervention and Positive Psychological Training on Cognitive Processing and Blood Pressure Control in African Americans

Acronym: TechSupport

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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