Technology-based Intervention and Positive Psychological Training for Blood Pressure Control in African Americans (TechSupport)
11 septembre 2020 mis à jour par: Carolyn Still, Case Western Reserve University
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
18
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Ohio
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Cleveland, Ohio, États-Unis, 44143
- Case Western Reserve University
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
25 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: 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.
|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in systolic and diastolic blood pressure
Délai: 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]
Délai: 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]
Délai: 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]
Délai: 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]
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Carolyn H Still, PhD, University Hospitals Cleveland Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
25 octobre 2018
Achèvement primaire (Réel)
31 juillet 2019
Achèvement de l'étude (Réel)
31 juillet 2019
Dates d'inscription aux études
Première soumission
25 octobre 2018
Première soumission répondant aux critères de contrôle qualité
25 octobre 2018
Première publication (Réel)
29 octobre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 septembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2020
Dernière vérification
1 septembre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5P30NR015326-05 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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