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

Not Applicable

Completed

• Conditions: Hypertension; Self-management; Technology
• Interventions: Behavioral: Technology-based Component; Behavioral: TechSupport

• Registration Number: NCT03722667
• Lead Sponsor: Case Western Reserve University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-10-25
• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-11
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technology-Based Component	Technology-based Component	A Technology-based interventions comprised of three technolgy components accessible via smartphone to support self-managing hypertension.
TechSupport	TechSupport	A Technology-based interventions comprised of three technolgy components plus positive psychological training accessible by smartphone to support self-managing hypertension.

Primary Outcome Measures

Name	Time	Method
Change in systolic and diastolic blood pressure	Baseline to 8 weeks and 12 weeks	Measure of participants' in clinic blood pressure (average of three blood pressure readings)
PROMIS Global Health-10 [health-related quality of life]	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.
PROMIS Short Form, Positive Affect -15a [positive affect and well-being]	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.
PROMIS- 29, Depression Subscale 4a [depressive symptoms]	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.
PROMIS- 29, Anxiety Subscale 4a [anxiety symptoms]	Baseline to 8 weeks and 12 weeks	Change in total summed PROMIS-29, Anxiety subscale. Higher scores indicate greater anxiety. Range is 4-20.

Trial Locations

Locations (1)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States