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| Name | Class |
|---|---|
| University Hospitals Cleveland Medical Center | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology-Based Component | Placebo Comparator | A Technology-based interventions comprised of three technolgy components accessible via smartphone to support self-managing hypertension. |
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| TechSupport | Experimental | A Technology-based interventions comprised of three technolgy components plus positive psychological training accessible by smartphone to support self-managing hypertension. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology-based Component | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn H Still, PhD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35302958 | Derived | 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. | |
| 33262580 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| TechSupport | Behavioral | 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. |
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