- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Cleveland, Ohio, Estados Unidos, 44143
- Case Western Reserve University
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in systolic and diastolic blood pressure
Periodo de tiempo: 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]
Periodo de tiempo: 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]
Periodo de tiempo: 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]
Periodo de tiempo: 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]
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carolyn H Still, PhD, University Hospitals Cleveland Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 5P30NR015326-05 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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