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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03722667
Other study ID # 5P30NR015326-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2018
Est. completion date July 31, 2019

Study information

Verified date September 2020
Source Case Western Reserve University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United States Case Western Reserve University Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Case Western Reserve University University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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