Hypertension Clinical Trial
— TechSupportOfficial title:
The Effects of Technology-based Intervention and Positive Psychological Training on Cognitive Processing and Blood Pressure Control in African Americans
Verified date | September 2020 |
Source | Case Western Reserve University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Western Reserve University | University Hospitals Cleveland Medical Center |
United States,
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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