Clinical trial NCT03722667: Technology-based Intervention and Positive Psychological Training for Blood Pressure Control in African Americans
Official title: The Effects of Technology-based Intervention and Positive Psychological Training on Cognitive Processing and Blood Pressure Control in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Self-management
Technology
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2018-10-29
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic and diastolic blood pressure
timeFrame: Baseline to 8 weeks and 12 weeks
measure: PROMIS Global Health-10 [health-related quality of life]
timeFrame: Baseline to 8 weeks and 12 weeks
measure: PROMIS Short Form, Positive Affect -15a [positive affect and well-being]
timeFrame: Baseline to 8 weeks and 12 weeks
measure: PROMIS- 29, Depression Subscale 4a [depressive symptoms]
timeFrame: Baseline to 8 weeks and 12 weeks
measure: PROMIS- 29, Anxiety Subscale 4a [anxiety symptoms]
timeFrame: Baseline to 8 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Carolyn H Still, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Still CH, Jack AI, Wright KD, Sattar A, Moore SM. Neural Processing of Health Information and Hypertension Self-Management in African Americans. Nurs Res. 2022 Jul-Aug 01;71(4):303-312. doi: 10.1097/NNR.0000000000000592. Epub 2022 Mar 18.
citation: Still CH, Margevicius S, Harwell C, Huang MC, Martin L, Dang PB, Wright Jnr JT. A Community and Technology-Based Approach for Hypertension Self-Management (COACHMAN) to Improve Blood Pressure Control in African Americans: Results from a Pilot Study. Patient Prefer Adherence. 2020 Nov 23;14:2301-2313. doi: 10.2147/PPA.S283086. eCollection 2020.