Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-04 @ 8:59 AM
Study NCT ID:
NCT03722667
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technology-based Intervention and Positive Psychological Training for Blood Pressure Control in African Americans
Sponsor:
Case Western Reserve University
Organization:
Study Overview
Official Title:
The Effects of Technology-based Intervention and Positive Psychological Training on Cognitive Processing and Blood Pressure Control in African Americans
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TechSupport
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: