- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03722667
Technology-based Intervention and Positive Psychological Training for Blood Pressure Control in African Americans (TechSupport)
The Effects of Technology-based Intervention and Positive Psychological Training on Cognitive Processing and Blood Pressure Control in African Americans
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:
- 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.
- Determine whether there are differences in self-management behaviors (medication adherence, diet, exercise, self-monitoring BP) between the two groups.
- 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.
- Determine if social support, demographics (age, gender, education), discrimination, and technology utilization moderate self-management behaviors, BP, HRQoL, and psychological health.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44143
- Case Western Reserve University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Technology-Based Component
A Technology-based interventions comprised of three technolgy components accessible via smartphone to support self-managing hypertension.
|
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.
|
Experimental: TechSupport
A Technology-based interventions comprised of three technolgy components plus positive psychological training accessible by smartphone to support self-managing hypertension.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in systolic and diastolic blood pressure
Time Frame: Baseline to 8 weeks and 12 weeks
|
Measure of participants' in clinic blood pressure (average of three blood pressure readings)
|
Baseline to 8 weeks and 12 weeks
|
PROMIS Global Health-10 [health-related quality of life]
Time Frame: 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.
|
Baseline to 8 weeks and 12 weeks
|
PROMIS Short Form, Positive Affect -15a [positive affect and well-being]
Time Frame: 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.
|
Baseline to 8 weeks and 12 weeks
|
PROMIS- 29, Depression Subscale 4a [depressive symptoms]
Time Frame: 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.
|
Baseline to 8 weeks and 12 weeks
|
PROMIS- 29, Anxiety Subscale 4a [anxiety symptoms]
Time Frame: Baseline to 8 weeks and 12 weeks
|
Change in total summed PROMIS-29, Anxiety subscale.
Higher scores indicate greater anxiety.
Range is 4-20.
|
Baseline to 8 weeks and 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn H Still, PhD, University Hospitals Cleveland Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5P30NR015326-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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